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Career Opportunities
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Career Opportunities
 
POSITIONS AVAILABLE:
 
Kansas City, MO Positions:
 
  • QC Supervisor, Kansas City, MO
  • General Summary Description
    The QC Supervisor is responsible for coordinating, planning and monitoring all activities of the Quality Control Department to ensure QC laboratory operates following written procedures, ICH & cGMP Guidelines.
    Duties and Responsibilities
    • Responsible for review and quality control release of raw materials,, in-process, finished products, and stability testing for drug substance and drug products.
    • Oversees the scheduling for testing.
    • Ensures all laboratory personnel are properly trained, have the proper knowledge and skillset to complete day to day activities with quality, integrity, and compliance.
    • Manages laboratory investigations to ensure accuracy, scientific rationale and completed in a timely fashion.
    • Coordinates with instrument calibration program to safeguard all equipment used in the laboratory is within calibration, and routine maintenance has been performed.
    • Reviews and/or updates changes to SOP(s)/STM(s)/Annexures and/or specifications related to QC.
    • Troubleshoots QC instruments.
    • Assists in data processing for integration.
    • Assist in Stability Pull dates, Stability Testing due dates and Stability Review dates.
    • Initiates all laboratory investigations (non-LIR & LIR) and develops investigational plan.
    • Reviews final report which goes to QA for final disposition.
    • Assists with returned goods investigations, product complaint investigations, and product recalls.
    • Performs other duties as assigned .
    Direction Received : Organize own work with very little direction
    Analytical Requirements :
    Decisions and Judgment : Primarily manages a department/division including interviewing, selecting and training employees. Directs work and appraises performance of 2 or more full-time regular employees with the authority to hire, fire and recommend advancement or promotion
    Initiative : Independent action within an established field is required; new procedures and new approaches to problems must be assigned
    Minimum Qualifications
    Bachelors Degree in Chemistry, Pharmacology, Pharmaceutics, Biology or related field with 5-8 years cGMP requirements experience in pharmaceutical, biotech, and/or medical device industry required. Masters degree and 2-5 years experience preferred.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/Skills :
    • Ten-key calculator by touch
    • Ability to use general office equipment
    • Proficient in Microsoft Word and Excel
    • Knowledge of Balance, Dissolution Bathes, AA, and HPLC
    • Strong communication skills
    • Exceptional attention to detail
    • Basic typing skills
    • Excellent supervisory skills
    Work Environment :
    • Office environment
    • Laboratory environment
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • A/P ACCOUNTANT, Kansas City, MO
  • General Summary Description
    The A/P Accountant performs duties as described in the job description with respect accounts payable and other tasks related to the general ledger.
    Duties and Responsibilities
    • Prepare A/P invoices backed up with purchase order and packing slip when applicable to be entered into Great Plains.
    • Update daily the check register, cash summary, A/P cash flow, and lockbox deposit schedule.
    • Maintain various A/P files, accounting reports, and W-9 Forms.
    • Generate purchase orders and follows up on invoices.
    • Review and process expense reports submitted by associates.
    • Prepare approved checks to be mailed.
    • Prepare and send out appropriate sales tax exemption certificates.
    • Complete credit applications for vendors.
    • Draft SOPs for general laboratory procedures.
    • Reconcile bank accounts, credit card accounts, petty cash account, and various vendor accounts.
    • Prepare and enter the quarterly Medicaid rebate into the A/P system.
    • Assist in the annual financial audit.
    • Perform other duties as assigned.
    Direction Received : Initial direction for each job
    Analytical Requirements : Duties are of a routine clerical nature
    Decisions and Judgment : No authority to commit the organization in negotiations or with respect to finances
    Initiative : Procedures are established, but conditions change; initiative must be exercised to overcome minor obstacles
    Minimum Qualifications
    Bachelors Degree and 1-2 years experience or equivalent combination of education and experience required. Prefer 2-5 years experience with degree.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/Skills :
    • Preferred Knowledge of Great Plains and/or any other accounting software
    • Excellent attention to detail
    • Proficient in Microsoft Office Suite
    • Ability to use general office equipment
    • Excellent customer service skills
    • Ten-key calculator by touch
    • Exceptional attention to detail
    • Knowledge of generally accepted accounting principals
    • Strong oral and written communication skills
    • Ability to handle confidential information in a sensitive manner
    Work Environment :
    • Office environment
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • PACKAGING TECHNICIAN - Kansas City, MO
  • General Summary Description
    The Packaging Technician performs routine packaging operations for the production of pharmaceutical products; operates packaging line equipment according to established SOPs and department procedures.
    Duties and Responsibilities
    • Prepares and cleans room, equipment, facility and documents for manufacturing and packaging process
    • Verifies calculations, process steps and yield
    • Ensures that processes, tools, products and materials meet established quality standards and requirements
    • Notifies management when inventory fails below certain levels
    • Assists in the assembly and disassembly of process equipment as necessary
    • Examines sample of finished product per batch record instructions for conformance with specifications
    • Notifies supervisor of manufacturing / packaging deviations and assists with proper resolution/documentation
    • Documents manufacturing and packaging steps and ensures documentation is complete and current to process step
    • Moves product to, from and within production area
    • Performs cGMP manufacturing operations utilizing SOPs, Batch Records and Form Preps
    • Basic equipment troubleshooting skills
    • Performs other duties as assigned
    Direction Received : Light direction that requires only general instruction to begin assigned duties and work is reviewed after completion
    Analytical Requirements : There is a choice of standard procedures
    Decisions and Judgment : No authority to commit the organization in negotiations or with respect to finances
    Initiative : Work is repetitive and well covered by instruction
    Minimum Qualifications
    A High School Diploma and 1 year relevant work experience in the pharmaceutical, food, manufacturing, biotech or healthcare industry or equivalent combination of education and experience required.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/Skills :
    • Strong communication skills
    • Excellent attention to detail
    • Familiar with good manufacturing practices
    • Possess basic troubleshooting skills
    • Basic knowledge of machines and equipment
    Work Environment :
    • Production environment with moderate levels of noise
    • Exposure to moving parts and particles from the manufacturing process
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • CHEMIST I - Kansas City, MO
  • General Summary Description
    The Chemist I is responsible for developing and validating test methods; validating laboratory instruments; conducting lab testing for raw materials, components, in-process materials, finished products, stability, and other samples in accordance with cGMP regulations, regulatory filings, and approved procedures.
    Duties and Responsibilities
    • Performs quality control release testing for impurity, moisture, dissolution, dosage, etc.
    • Reviews testing from other analysts in the quality control
    • Documents work in the lab notebook and annexures
    • Discards expired reagents and samples after the review has been completed
    • Performs validation/verification studies for test methods and cleaning verification
    • Prepares reports of testing, analysis, and conclusions
    • Prepares spreadsheets, Analytical Report Forms and Certificates of Analysis with quality and diligence
    • Creates data packet for drug substance, drug products, product stability and validation/verification studies
    • Conducts daily calibration check as needed
    • Performs logging of submitted samples as necessary
    • Creates and ensures review of specification setting, change controls, and laboratory investigations
    • Assists in pulling samples from stability chamber and logging sample as necessary
    • Assists as needed to complete data for ANDA submission
    • Performs other duties as assigned
    Direction Received : Light direction that requires only general instruction to begin assigned duties and work is reviewed after completion
    Analytical Requirements : Assignments frequently involve decisions based on a wide knowledge of many factors where application of advanced or technical concepts are pedominantly required
    Decisions and Judgment : Provides consultation or expert advice to management on operational issues
    Initiative : Work is performed under direct supervision
    Minimum Qualifications
    Bachelors Degree in Chemistry, Pharmaceutical, Biology or a science related field or equivalent combination of education and experience are required. Bachelors Degree with cGMP Training is preferred.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/Skills :
    • Ten-key calculator by touch
    • Ability to use general office equipment
    • Proficient in Microsoft Word and Excel
    • Knowledge of Balance, Dissolution Bathes, AA, and HPLC
    • Strong communication skills
    • Exceptional attention to detail
    • Basic typing skills
    Work Environment :
    • Office environment
    • Laboratory environment
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • MANUFACTURING OPERATOR I - KANSAS CITY, MO
  • The Manufacturing Operator I performs routine manufacturing operations for the production of pharmaceutical products; operates production equipment according to established SOPs and department procedures.
    JOB REQUIREMENTS:
    • Prepares and cleans room, equipment, facility and documents for manufacturing and packaging processes
    • Operates Tablet presses, Glatt Fluid Bed dryers, High Sheer Granulators, Blenders, MG Encapsulators and other equipment to manufacture pharmaceutical pills, tablets, and capsules
    • Troubleshoots equipment and/or process as required to maintain flow of production
    • Performs standardization of associated equipment
    • Verifies calculations, process steps and yield
    • Follows the master production batch records
    • Ensures that processes, tools, products, and materials meet established quality standards and requirements
    • Notifies management of process difficulties
    • Assemble and Disassemble equipment for cleaning or for manufacturing use
    • Ensure cleaning of manufacturing support areas are performed as required
    • Samples in process and finished product per batch record instructions for conformance with specifications
    • Notifies supervisor of manufacturing/packaging deviations and assists with proper resolution/documentation
    • Documents manufacturing and packaging steps and ensures documentation is complete and current to process step
    • Moves product to, from, and within production area
    • Performs cGMP manufacturing operations utilizing SOPs, Batch Records, and Form Preps
    • Performs other duties as assigned
    WORK LOCATION: Kansas City, MO
    APPLICANTS:
    Send resume to: hrinfo@nostrumlabs.com
     
     
  • IT TIER I - Kansas City, MO
  • General Summary Description
    The IT Tier I position is responsible for assessing and troubleshooting computer support problems and applies understanding of computer software and hardware products and services to resolve problems of users, supporting day to day IT operations, managing the office network, and working in IT operations with our satellite offices as instructed. This individual must also be able to multitask effectively and maintain our network reliability.
    Duties and Responsibilities
    • Understanding of IT to resolve technical as well as functional issues as directed by Senior IT personnel
    • Research new technologies to apply to the organization in the most efficient manner
    • Adheres to direction from IT to perform job duties while adhering to the schedule & scope
    • Administrates phone system, data network, security system, video surveillance, and access control as instructed by Senior IT personnel
    • Maintains user access control, printer issues, connectivity issues and other day to day user issues
    • Participates in IT meetings
    • Updates project plans for IT projects including objectives, technologies, systems, information specifications, schedules
    • Confers with IT personnel to identify problems
    • Assists in specialist projects as requested by Senior IT personnel
    • Participates in meetings, workshops, and seminars for the purpose of conveying and/or gathering information required to perform job functions
    • Deploys desktops, laptops, monitors, phones, and peripherals as instructed by Senior IT personnel
    • Troubleshoot and repair malfunctioning IT managed equipment such as desktops, laptops, phones, etc and software
    • Backup and/or work (as needed) for cross location support
    • Willing to work overtime (Extended shifts and weekends) as needed
    • Performs other duties as assigned
    Direction Received : Immediate or frequent direction
    Analytical Requirements : There is a choice of standard procedures
    Decisions and Judgment : No authority to commit the organization in negotiations or with respect to finances
    Initiative : Work is performed under direct supervision
    Minimum Qualifications
    High School diploma or equivalent with 1 to 2 years related IT experience or equivalent combination of education and experience required.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/Skills :
    • Windows Server 2008/2012
    • Ability to use general office equipment and general computer proficiency
    • Hands on experience of installing IT hardware and software
    • Familiarity with network switches, routers, firewall, and servers
    • Strong telephone, written and verbal skills
    • Experience with IT operating systems: Windows, and otherwise
    Work Environment :
    • Warehouse, Office, Production, Maintenance Shop, Outside office (as required), and other such environments
    • Moderate levels of noise and moving equipment
    • Able to climb ladders and work in narrow and small areas
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • CUSTODIAN I - Kansas City, MO
  • General Summary Description
    The Custodian I is responsible for the general cleaning and sanitizing of the Nostrum Laboratories, Inc. facility.
    Duties and Responsibilities
    • General cleaning of the non-manufacturing areas, change rooms, gowning rooms, general offices, lobby, Warehouses, QA offices, QC offices, lunchroom, conference room, all facility restrooms, and copy rooms
    • Cleaning of the buildings exterior windows
    • Cleaning of the break room appliances
    • Mopping tile floors (lunchroom, restrooms, lab) as assigned
    • Perform Daily, Weekly and monthly cleaning in Manufacturing according to SOPs
    • Proficient with the uses of brooms, dust pans, mops, dusters, vacuums, cleaners, and disinfectants
    • Stocking of restroom and break-room consumables (plastic silverware, coffee & condiments, paper towels, napkins, & restroom supplies, etc.)
    • Comfortable with the safe and sanitary cleaning up of bodily fluids
    • Follows and enforces all SOPS and regulations in the Maintenance & Engineering department
    • Maintains good documentation practices
    • Notify supervisor of areas or equipment possibly needing repair
    • Performs other duties as assigned
    • Willing to work overtime (Extended shifts and weekends) as needed
    Direction Received : Light direction that requires only general instruction to begin assigned duties and work is reviewed after completion
    Analytical Requirements : There is a choice of standard procedures
    Decisions and Judgment : No authority to commit the organization in negotiations or with respect to finances
    Initiative : Procedures are established, but conditions change; initiative must be exercised to overcome minor obstacles
    Minimum Qualifications
    High School diploma and 0-3 years relevant work experience or equivalent combination of education and experience required. Ability to read, understands, and follows standard operating procedures. Good written and verbal communication skills with the ability to interact with individuals at all levels. Some computer and documentation skills required.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/Skills :
    • Good knowledge of cleaning equipment & chemicals
    • Moderate communication and telephone skills
    • Moderate computer proficiency
    • Ability to use general office equipment and general computer proficiency
    Work Environment :
    • Warehouse, Office, Production, and Maintenance Shop environment
    • Moderate levels of noise and moving equipment
    • Use shovel to remove snow and pour salt to driveway and entrances
    • Exposure to dust and cleaning chemicals
    • Pulling and cutting weeds
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • Logistics Operator I - Kansas City, MO
  • General Summary Description
    The Logistics Operator I performs weighing activities for APIs and excipients in addition to operation of equipment for the preparation of pharmaceutical APIs and excipients for weighing according to established SOPs and department procedures.
    Duties and Responsibilities
    • Prepares and cleans room, equipment, facility and documents for weighing processes
    • Performs standardization of all equipment associated with the Weighing Process as deemed necessary
    • Verifies calculations, process steps and yield
    • Ensures that processes, tools, products, and materials meet established quality standards and requirements
    • Determines, monitors, and maintains inventory of necessary raw materials
    • Notifies management when inventory fails below certain levels
    • Assists in the assembly and disassembly of process equipment as necessary
    • Examines sample of finished product per batch record instructions for conformance with specifications
    • Notifies supervisor of manufacturing/packaging deviations and assists with proper resolution/documentation
    • Documents manufacturing steps and ensures documentation is complete and current to process step
    • Moves product to, from, and within production area
    • Performs cGMP manufacturing operations utilizing SOPs, Batch Records, and Form Preps
    • Performs other duties as assigned
    Direction Received : Light direction that requires only general instruction to begin assigned duties and work is reviewed after completion
    Analytical Requirements : There is a choice of standard procedures
    Decisions and Judgment : No authority to commit the organization in negotiations or with respect to finances
    Initiative : Work is performed under direct supervision
    Minimum Qualifications
    A High School Diploma and 0-3 years relevant work experience in the pharmaceutical or biotech industry, or equivalent combination of education and experience required.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/Skills :
    • Strong communication skills
    • Excellent attention to detail
    • Familiar with good manufacturing practices
    • Possess basic troubleshooting skills
    • Basic knowledge of machines and equipment
    Work Environment :
    • Production environment with moderate levels of noise
    • Exposure to moving parts and particles from the manufacturing process
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
    Bryan, Ohio Positions:
     
  • DIRECTOR, QUALITY, Bryan, Ohio
  • General Summary Description
    The Director is responsible for building, maintaining, and improving the Quality Unit, which includes both Quality Assurance and Quality Control, to help ensure compliance with cGMP regulations related to drug safety, identity, strength, quality, and purity while developing personnel to have scientific and technical understanding, product knowledge, process knowledge and/or risk assessment abilities to appropriately execute duties, by identifying specific qualifications, such as education, training, and experience.
    Duties and Responsibilities
    • Oversees the testing results from Quality Control are complete, accurate, and documented according to established written procedures that meet regulations operational aspects
    • Directs Quality Unit regarding deviations from established procedures to ensure appropriate documentation
    • Ensures any changes that may impact product quality are documented and/or investigated according to procedure
    • Coordinates and maintains Quality Board meetings regarding deviations and investigations related to batch records and/or manufacturing processes
    • Monitors instrument activity and utilization along with testing plans in the Quality Control laboratory
    • Reviews and approves changes to procedures and/or specifications related to QC, QA, and Manufacturing
    • Interacts with Regulatory Affairs for deficiencies
    • Evaluates testing required for Product Complaints and conducts risk assessments
    • Performs other duties as assigned
    Direction Received : No day to day direction or instruction necessary to accomplish assigned duties
    Analytical Requirements : Assignments frequently involve decisions based on a wide knowledge of many factors where application of advanced or technical concepts are pedominantly required
    Decisions and Judgment : Provides consultation or expert advice to management on operational issues
    Initiative : Problems are of a difficult nature and supervision is limited to assignments and discussion of problems
    Minimum Qualifications
    Bachelors Degree in Chemistry, Pharmacology, Pharmaceutics or related field with 8-12 years experience in pharmaceutical, biotech and/or medical device and supervisory experience required. Masters Degree with 5-8 years experience and CQA, ASQ, ACS, and ASM certification is preferred.
    Additional Requirements
    Licenses/Certification :
    • CQA, ASQ, ACS, and ASM is preferred
    Special Requirements/Skills :
    • Excellent written and oral communication skills
    • Proficient in Microsoft Office Suite
    • Knowledge of HPLC, GC, Dissolution, Compression, and Granulation
    • Excellent presentation skills
    • Strong customer service skills
    • Ability to work effectively with all levels of employees and management
    • Ability to use general office equipment and general computer proficiency
    • Strong motivational and delegation skills
    • Excellent supervisory skills
    • Demonstrated problem solving and critical thinking skills
    • Ability to organize own work with very little direction
    • Strong discretion of confidential matters and overall business ethics
    Work Environment :
    • Office environment
    • Laboratory environment
    • Production Warehouse
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • CHEMIST I, Bryan, Ohio
  • General Summary Description
    Responsible for development and validation of analytical methods in support of product development and IND/NDA/ANDA filings. Perform routine wet chemical and instrumental analysis on raw materials, in-process, finished and stability products. Accurately compiles and reports data. Gather, compile and compose documents needed for regulatory submissions.
    Duties and Responsibilities
    • Develop and validate analytical test methods for assay, dissolution, impurities/degradation products in drug products according to ICH/FDA/USP requirements
    • Develop and validate test methods for residual solvents in drug substances/excipients according to ICH/FDA/USP requirements
    • Perform complex routine and non-routine physical and chemical tests on raw materials, API's, in-process and finished products and test R&D trial batches and associated stability studies and generate analysis report
    • Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report
    • Responsible for developing and executing analytical protocols (e.g. Method validation) and drafting the test methods and validation reports
    • Develop test methods for evaluating both the physical and chemical aspects of new pharmaceutical products
    • Maintain good documentation practices and proper laboratory notebooks. Review other scientists' notebooks when required
    • Create RFAs
    • Draft SOPs for general laboratory procedures
    • Provide regular update reports on progress of projects
    • Multi-task by working on several simultaneous projects
    • Perform trouble-shooting and investigations under the direction of management
    • Comply with all relevant regulatory requirements
    • Other projects and duties as required or assigned
    Direction Received : Initial direction for each job
    Analytical Requirements : There is a choice of standard procedures
    Decisions and Judgment : Recommendations based on the development of facts concerning conformity with a known standard or set policy and procedures
    Initiative : Work is variable but methods have been established and initiative is required to maintain the flow of work
    Minimum Qualifications
    Bachelors Degree and 0 - 4 years of relevant experience or equivalent combination of education and experience required. Masters Degree or PhD with 0 - 2 years preferred.
    Additional Requirements
    Licenses/Certification :
    • None
    Instrumentation/techniques :
    • Viscometer
    • UV/Vis spectrophotometer, IR spectroscopy
    • FT-IR
    • Wet chemistry techniques
    • USP Dissolution apparatus I and II apparatus
    • HPLC/UPLC with UV variable wavelength, PDA, RI, Fluorescence, CAD detectors
    • GC
    • Optical and specific rotation apparatus
    • Particle size analyzer
    • TLC
    Special Requirements/Skills :
    • Proficient in Microsoft Office
    • Ability to use general office equipment and general computer proficiency
    • Advanced knowledge of handling raw materials, and corrosive reagents
    • Perform analysis utilizing Chromatography software
    • Strong communication skills
    • Maintains confidentiality
    Work Environment :
    • Office environment
    • Laboratory environment with exposure to chemicals and testing material
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • QC LAB TECHNICIAN I, Bryan, Ohio
  • General Summary Description
    The QC Technician I is responsible for conducting non-complex analytical tests for raw materials, components, in-process materials, finished products, other samples as assigned, in accordance with cGMP regulations, regulatory filings, and approved procedures.
    Duties and Responsibilities
    • Performs elementary/simple quality control release tests for Active Pharmaceutical Ingredients, Excipients, Packaging, Labeling, release-to-pack, in-process, bulk drug product and product stability
    • Prepares Analytical Test Reports (ATRs) of assigned QC tests and performs corrections to ATRs, as needed, upon review
    • Reviews Analytical Test Reports from other analysts, as assigned by supervisor in the quality control laboratory
    • Assists with maintaining laboratory inventory and equipment
    • Assists with investigations, change controls, regulatory submissions and updates, annual product reviews, and other investigations as assigned by supervisor
    • Complies with Good Documentation Practices with respect to documentation of work in the lab notebook and annexures
    • Performs other duties as assigned
    Direction Received : Initial direction for each job
    Analytical Requirements : Duties are of a routine clerical nature
    Decisions and Judgment : No authority to commit the organization in negotiations or with respect to finances
    Initiative : Work is repetitive and well covered by instruction
    Minimum Qualifications
    High School Diploma or Associates Degree and 1-2 years experience in pharmaceutical, medical, life sciences laboratory, or equivalent combination of education and experience required.
    Additional Requirements
    Licenses/Certification :
    • None
    Instrumentation/techniques :
    • Knowledge of basic laboratory techniques such as analytical balance use, pH measurement, use of calibrated laboratory glassware, organoleptic tests, specific gravity, preparation of solutions
    • Ten-key calculator by touch
    • Ability to use general office equipment
    • Proficient in Microsoft Word and Excel
    • Strong communication skills
    • Exceptional attention to detail
    • Basic typing skills
    Work Environment :
    • Office environment
    • Laboratory environment with exposure to chemicals and testing material
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • QC MANAGER, Bryan, Ohio
  • General Summary Description
    The QC Manager ensures that GMP's are followed; analytical results are properly documented and are accurate. Ensures deadlines are met for releases, calibrations, stabilities, investigations and projects. The QC Manager certifies that all employees in the QC Department are trained and qualified for the work they perform.
    Duties and Responsibilities
    • Approves analytical worksheets, calibrations, chart recorder records, test procedures and data packets
    • Assists and approves with outside testing lab investigations and QC internal investigations
    • PReviews and approves analysts training
    • Reviews and approves contractors and contract laboratories
    • Assists in DEA paperwork and end of year inventory
    • Develop test methods for evaluating both the physical and chemical aspects of new pharmaceutical products
    • Assists and approves with QA audits of worksheets, instrument log books and training books
    • Oversees analysts scheduling to ensure deadlines are met
    • Attends meetings and works on projects to improve systems in the QC Department
    • Manages and works with QC supervisors
    • Approves audits of Laboratory log books
    • Approves and conducts laboratory investigations
    • Performs other duties as assigned
    Direction Received : No day to day direction or instruction necessary to accomplish assigned duties
    Analytical Requirements : Assignments frequently involve decisions based on a wide knowledge of many factors where application of advanced or technical concepts are pedominantly required
    Decisions and Judgment : Provides consultation or expert advice to management on operational issues
    Initiative : Procedures are established, but conditions change; initiative must be exercised to overcome minor obstacles
    Minimum Qualifications
    Bachelors Degree in Chemistry, Pharmaceutical Sciences or a related field and 5+ years experience, or equivalent combination of education and experience required. Masters Degree preferred.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/ Skills :
    • Ability to use general office equipment and general computer proficiency
    • Proficient in Microsoft Office and Total Chrom
    • Knowledge of LC, GC, FTIR, Disso, UV, pH, and Balances
    • Strong communication skills and presentation skills
    • Comfortable communicating with Federal Departments such as FDA and DEA
    • Excellent supervisory skills
    Work Environment :
    • Experience working in a QC laboratory
    • Chemistry Laboratory
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • QA SUPERVISOR, Bryan, Ohio
  • General Summary Description
    Supervises daily functions of the QA Department in support of operational needs for manufacturing, packaging, quality control and distribution of drug products. This is accomplished through document administration, material review and release, investigations and tracking of timelines for time sensitive material. Supervises personnel who provides assistance in support of the QA department function.
    Duties and Responsibilities
    • Finished Product Release to market
    • Technical review and approval of documentation for accuracy and completeness according to cGMPs to ensure timely release to include but not limited to: o Master Batch and Packaging Records, Protocols, Reports o Raw Material Release o Packaging Component Release o Stability Data o Investigations o Annual Quality Review
    • Change Control Review and Approval
    • Ensures all GMP SOPs are followed
    • Quality Assurance Monthly Report
    • Internal Auditing
    • Provide QA support for ANDA submissions
    • Review and approval of labeling or labeling revisions
    • Perform other duties as assigned
    Direction Received : Organize own work with very little direction
    Analytical Requirements : There is a choice of standard procedures
    Decisions and Judgment : No authority to commit the organization in negotiations or with respect to finances
    Initiative : Work is variable but methods have been established and initiative is required to maintain the flow of work
    Minimum Qualifications
    Degree in Chemistry, Pharmaceutical Sciences or a related field and 5+ years experience, or equivalent combination of education and experience required.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/ Skills :
    • Ability to use general office equipment and general computer proficiency
    • Proficient in Microsoft Word and Excel
    • Knowledge of LC, GC, IR, Disso, pH, IC, AA, Balances
    • Strong communication skills and presentation skills
    • Comfortable communicating with Federal Departments such as FDA
    • Excellent supervisory skills
    Work Environment :
    • Office environment
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • QA MANAGER - COMPLIANCE, Bryan, Ohio
  • General Summary Description
    Duties and Responsibilities
    • Manages quality assurance compliance activities, including the following
    • Tracking of deviations and investigations to completion, assuring that batches remain on-site in Quarantine status until the deviation or investigation is closed
    • Ensuring that deviations or investigations list appropriate and achievable CAPA requirements
    • Tracking of CAPAs to completion, including maintaining a spreadsheet of CAPA due dates and if not complete, that the personnel responsible for the activity complete interim reports on time until CAPAs are closed
    • Manage the Vendor qualification program including External Audits and Qualification of the materials, active ingredients, excipients and services of vendors and service providers
    • Conduct external audits to ensure that materials and services produced are consistent with the requirements of specifications or regulatory commitments
    • Ensures appropriate external audit reports are completed and that written responses are completed in accordance with the vendor quality risk and Nostrum vendor qualification SOP
    • Ensures that Quality Agreements are completed for raw material and service providers
    • Conduct internal audits to ensure conformance to established Nostrum standard operating procedures, batch processing documents, analytical methods, training requirements, and conformance of processes to regulatory submissions
    • Ensures appropriate internal audit reports are completed and that written responses are completed in accordance with the quality risk
    • Ensures that current practices are accurately documented and adequately followed
    • Perform other duties as assigned
    Direction Received : No day to day direction or instruction necessary to accomplish assigned duties
    Analytical Requirements : Duties are of a complex nature requiring judgment for which there are no precedents
    Decisions and Judgment : Primarily manages a department/division including interviewing, selecting and training employees. Directs work and appraises performance of 2 or more full-time regular employees with the authority to hire, fire and recommend advancement or promotion
    Initiative : Complicated work with few precedents, performed independently, virtually without supervision
    Minimum Qualifications
    Bachelors Degree in Pharmaceutical, Science, or related field with 4 years experience in pharmaceutical, biotech, and/or medical device industry or equivalent combination of education and experience required.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/ Skills :
    • Ability to use general office equipment and advanced computer proficiency
    • Expert Knowledge of cGMP requirements
    • Knowledge of ISO13485 requirements
    • Proficient in Microsoft Word and Excel
    • Excellent written and verbal communication
    • Excellent supervisory skills
    • Exceptional attention to detail with advanced documentation skills
    Work Environment :
    • Office environment
    • Some travel is required
    • Exposure to moving parts and particles from the manufacturing process
    • Warehouse environment with exposure to dust and temperature variances
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • MICROBIOLOGIST I, Bryan, Ohio
  • General Summary Description
    Duties and Responsibilities
    • Perform all testing on in-house and contract samples as needed:

      o In-process

      o Finished product

      o Stability

      o Raw material (including water)

      o Environmental Testing

    • Performs Antimicrobial Effectiveness Testing
    • Identification of unknown and quality control challenge organisms (Biolog system)
    • Update and revise Microbiology documents
    • Internal Auditing
    • Assist with validation of microbial methods and test samples
    • Keep training book up to date
    • Peer review
    • Assist with training of Micro. Personnel
    • Obtain cross training
    • Cooperate in safety functions
    • Maintain environmental monitoring data base and prepare trending analysis/graphs
    • Participate in investigations
    • Perform other duties as assigned
    Direction Received : Initial direction for each job
    Analytical Requirements : There is a choice of standard procedures
    Decisions and Judgment : No authority to commit the organization in negotiations or with respect to finances
    Initiative : Work is repetitive and well covered by instruction
    Minimum Qualifications
    Bachelors Degree in Biology or Microbiology, laboratory experience through related course work, or equivalent combination of education and experiences required.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/ Skills :
    • Ability to use general office equipment and general computer proficiency
    • Proficient in Microsoft Office and Excel
    • Knowledge of microbiology lab equipment
    • Strong communication skills and presentation skills
    • Comfortable communicating with Federal Departments such as FDA
    • Knowledge of aseptic technique
    • Strong organization skills
    Work Environment :
    • Office environment
    • Lab environment
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
    8) QA TECHNICIAN I , Bryan, Ohio
    General Summary Description
    Duties and Responsibilities
    • Trending of IP/FP and Analytical data for annual APRs
    • Trending of IP/FP and Analytical data in Minitab for CPV
    • Raw Material Trending and Reports
    • Prepare Annual Product Reviews
    • Handle Customer Inquiries
    • Training Functions (compliance wire, data entry, cGMP training)
    • Provide Regulatory support for ANDA CMC submissions
    • Data Entry
    • Provide Support for QA Matrix for Monthly Report
    • Issue Visitor Badges
    • Assists on Vendor and Outside Lab GMP Questionnaires
    • Coordinates BSE/TSE/Allergin /Residual Solvents Letters
    • Ensures all GMPs SOPs and protocols are followed
    • Perform additional duties required by Quality Assurance
    • Maintain Vendor Files and Prepare Compliance Reviews
    • Review of Raw Materials and Packaging Components
    • Review of Stability Data Packets
    • Review of Production Records
    • Filing
    Direction Received : Initial direction for each job
    Analytical Requirements : There is a choice of standard procedures
    Decisions and Judgment : No authority to commit the organization in negotiations or with respect to finances
    Initiative : Work is performed under direct supervision
    Minimum Qualifications
    A High School diploma/GED and 1 year of manufacturing or quality experience or equivalent combination of education and experience required.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/ Skills :
    • Moderate typing skills and ten-key by touch
    • Strong written, communication and problem solving skills
    • Ability to use general office equipment and general computer proficiency
    • Strong knowledge of Microsoft Office Suite (Word, Excel, Outlook)
    • Comfortable communicating with Federal Departments such as FDA
    • Knowledge of aseptic technique
    • Strong organization skills
    Work Environment :
    • Office environment
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
  • METROLOGIST I , Bryan, Ohio
  • General Summary Description
    Duties and Responsibilities
    • Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements
    • Identifies magnitude of error sources that contribute to uncertainty of results to determine reliability of measurement process in quantitative terms
    • Calibrates/qualifies a variety of process laboratory equipment, measurement/control instrumentation, and software
    • Conducts daily calibration check as needed
    • Schedule and perform calibrations according to SOPs or manufactures procedures on Measurement and Test Equipment insuring schedule work requirements are met
    • Completes all calibration certificates
    • Ensures accuracy, reliability, and compliance with operating procedures
    • Performs data entry functions required to update the calibration database, as required
    • Initiates instrument/document change control as necessary
    • Maintains documentation according to SOPs and cGMP requirements
    • Writes, develops, and reviews Standard Operating Procedures
    • Reviews and approves equipment specifications
    • Orders parts and instruments as necessary for calibration and maintenance
    • Coordinates with instrument manufacturers for scheduled services
    • Tech support and services to address laboratory instrumentation and troubleshooting
    • Maintains and supports troubleshooting for all laboratory equipment including but not limited to HPLC, GC, Dissolution and Disintegration Baths, Moisture Balances, Karl Fisher Titrator and pH Meters
    • Performs other duties as assigned
    Direction Received : Light direction that requires only general instruction to begin assigned duties and work is reviewed after completion
    Analytical Requirements : Assignments frequently involve decisions based on a wide knowledge of many factors where application of advanced or technical concepts are pedominantly required
    Decisions and Judgment : Develops guidebooks, manuals, or other policies and procedures for the organization or customers
    Initiative : Procedures are established, but conditions change; initiative must be exercised to overcome minor obstacles
    Minimum Qualifications
    A Bachelors Degree in Chemistry or Physical Science and 1 - 2 years relative work experience with laboratory instrumentation/repair or equivalent combination of education and experience required.
    Additional Requirements
    Licenses/Certification :
    • None
    Special Requirements/ Skills :
    • Ability to use general office equipment and general computer proficiency
    • Ability to make basic repairs and troubleshooting on mechanical equipment
    • Strong knowledge of HPLC, GC, UV-Vis, Disso-Bath, FTIR, pH Meter
    • Strong communication, presentation, and customer service skills
    • Familiar with cGMP requirements
    Work Environment :
    • Office environment
    • Laboratory environment
    Qualified Applicants:
     
    Please Contact:
    Shari Rapposelli
    Nostrum Laboratories, Inc.
    1800 N. Topping Ave.
    Kansas City, MO 64120
     
    Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com  
     
     
     
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