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Career Opportunities
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Career Opportunities
 
POSITIONS AVAILABLE:
 
1) PACKAGING TECHNICIAN
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  
 
 
2) MANUFACTURING MAINTENANCE MECHANIC II (Kansas City, MO)
The Manufacturing Maintenance Mechanic II is responsible for the troubleshooting, repair, and preventative maintenance and repair of all production equipment and support systems/utilities.
JOB REQUIREMENTS:
  • Monitors all manufacturing equipment on a routine basis for equipment condition, malfunctions, and/or maintenance
  • Performs preventative maintenance on manufacturing equipment and systems to meet FDA/GMP regulations
  • Completes appropriate documentation on work orders, PMs, and material orders
  • Monitors cleanliness of work areas and checks for safety hazards
  • Follows all SOPS and regulation and enforce in Maintenance & Engineering department
  • Maintains good documentation practices
  • Assembles, assists in the set-up, change over, operation and preventative maintenance on various pharmaceutical manufacturing equipment
  • Maintains equipment in operating condition according to FDA/government regulations
  • Follows gowning SOP when entering production area
  • Mounts and connects auxiliary, mechanical, electrical, electronic, pneumatic or hydraulic equipment
  • Performs, evaluates, and submits revisions to PMs to improve equipment reliability
  • Willing to work overtime (extended shifts and weekends) as needed
  • Supports off hours calls by being available
  • Performs other duties as assigned
WORK LOCATION: Kansas City, MO
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
3) 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
 
 
4) MANUFACTURING OPERATOR I – 2ND SHIFT (2pm – 10:30pm) (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
  • 2nd shift works 2pm – 10:30pm
  • Performs other duties as assigned
WORK LOCATION: Kansas City, MO
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
5) MANUFACTURING OPERATOR II - KANSAS CITY, MO
The Manufacturing Operator II 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
  • Performs training of other operators on manufacturing equipment and processes
  • Performs basic preventative maintenance on manufacturing equipment
  • Able to independently operate 2 or more major pieces of manufacturing equipment (Fluid Bed Dryer, Granulator, Blender, Tablet Press, Encapsulator, Tablet Coater)
  • Troubleshoots machine 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
  • Sample 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
 
 
6) LOGISTICS OPERATOR I - KANSAS CITY, MO
The Logistics Operator I performs weighing activities for API’s and excipients in addition to operation of equipment for the preparation of pharmaceutical API’s and excipients for weighing according to established SOPs and department procedures.
JOB REQUIREMENTS:
  • 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
WORK LOCATION: Kansas City, MO
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
7) CALIBRATION TECHNICIAN I - KANSAS CITY, MO
The Calibration Technician I is responsible for calibrating instruments and troubleshooting, installing and repairing mechanical components. In addition set up laboratory and testing equipment.
JOB REQUIREMENTS:
  • Calibrates a variety of process equipment, measurement/control instrumentation, and software
  • 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
  • Reviews all calibration certificates for conformance to established requirements
  • Initiates equipment change control as necessary and initiates a deviation if the calibration requirements are not met
  • Maintains documentation according to SOPs and cGMP requirements
  • Reviews and approves calibration requirements
  • Maintains and supports troubleshooting for all non-laboratory equipment
  • Performs other duties as assigned
WORK LOCATION: Kansas City, MO
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
8) MANUFACTURING SUPERVISOR - 2ND SHIFT - KANSAS CITY, MO
The Manufacturing Supervisor – 2nd shift is responsible for assisting in the planning and manufacturing of products, following SOPs, departmental procedures, and approved master batch records as written; as well as, proper use and documentation related to equipment, facilities, and batch manufacturing.
JOB REQUIREMENTS:
  • Prepares rooms, equipment, facility and documents for manufacturing
  • Provides guidance and supervision during manufacturing process to applicable manufacturing personnel, room, equipment and facility required for the applicable processes
  • Ensures intermediates and products are stored according to the requirements stated in the batch record
  • Ensures production employees are trained for jobs performed and training is documented related to applicable processes
  • Ensures manufacturing facilities, systems and equipment are calibrated and maintained requirements required for all processes
  • Conducts hands-on manufacturing of commercial and pre-commercial pharmaceutical products according to written procedures, inclusive of handling pharmaceutical raw materials, weighing and processing raw materials in an intermediate or finished pharmaceutical product as needed to conform to the production schedule
  • Provides guidance as assigned to manufacturing personnel during the course of day-to-day activities inside of manufacturing room or suite, inclusive of handling pharmaceutical raw materials, weighing and processing raw materials into an intermediate or finished pharmaceutical product
  • Trains manufacturing personnel in functional operations when specially assigned to do so
  • Assists in performing disciplinary action as directed and assisted by management; report pertinent job performance matters to management
  • Performs all required cleaning to facilitate timely startup of manufacturing as needed to conform to the production schedule
  • Manufactures batches and assists in resolving problems as they arise as needed to conform to the production schedule
  • Removes and submits samples per batch record instruction
  • Documents manufacturing steps and ensures documentation is complete
  • Informs material team leader about manufacturing and assist with resolutions
  • Processes paperwork
  • 2nd shift works 2pm – 10:30pm
  • Performs other duties as assigned
WORK LOCATION: Kansas City, MO
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
9) MANUFACTURING MAINTENANCE SUPERVISOR - KANSAS CITY, MO
The Manufacturing Maintenance Supervisor is responsible for the repair, preventative maintenance, setup, operation of pharmaceutical manufacturing equipment, supporting utilities and schedules the installation of machines, tools and equipment, as well as the coordination and direction of those who report to them in support of these responsibilities.
JOB REQUIREMENTS:
  • Supervises the Manufacturing Maintenance Team
  • Assigns work orders / PMs to Manufacturing Maintenance mechanics
  • Responsible for compliance of Quality Systems (ECC, work orders, PMs) maintaining cGMP compliance
  • Ensures accurate and documented SOPs, Work Orders and Preventive Maintenance forms are written for the Manufacturing Maintenance function
  • Notifies management, and Quality personnel to resolve maintenance problems and recommend measures to improve operations and conditions of machines and equipment
  • Assess the condition of the Manufacturing areas and performs corrective maintenance as necessary
  • Complete deviations, Investigations and CAPA within allotted time for completion
  • Uses reliability technologies to identify equipment that is not working within specifications
  • Troubleshoots equipment issues, adjusting, repairing, or replacing parts
  • Follows & enforces all SOPS and regulations in the Maintenance & Engineering department
  • Performs, evaluates, and submits revisions to PMs to improve equipment reliability
  • Identifies, sources, and orders wear and spare parts for inventory
  • Provides guidance and supervision to direct reports during the course of day-to-day activities
  • Ensures proper training of direct reports and documentation of such training
  • Assists in performing disciplinary action as directed and assisted by management; reports pertinent job performance matters to management
  • Supports off hours calls by being available or calling in employees under their supervision
  • Processes paperwork and ensures documentation accuracy of subordinates
  • Performs other duties as assigned
WORK LOCATION: Kansas City, MO
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
10) FORKLIFT OPERATOR II - KANSAS CITY, MO
The Forklift Operator II operates and drives battery or electric-powered industrial truck equipped with lifting devices, to push, pull, lift, stack, tier, or move products, equipment, or materials in warehouse.
JOB REQUIREMENTS:
  • Performs the disarming of the warehouse alarm and the startup procedures of the warehouse
  • Assists the warehouse manager with any needs
  • Receives, quarantines, and stores materials according to approved procedures
  • Inputs all transactions into computer database to maintain an accurate inventory
  • Issue materials to packaging, production, and R&D as directed
  • Follows first-in and first-out procedures based on quantity, expiry, and retest dating
  • Documents returns and destruction of materials
  • Conducts cycle counts for verification of warehouse accuracy
  • Pulls material to appropriately fill and ships orders
  • Dispatching shipment
  • Load and unload incoming and outgoing shipments
  • Schedule pick-ups for Finished Product
  • Schedule pick-ups for destruction
  • Schedules pick-ups of equipment, orders and samples for outside testing
  • Pulls necessary materials to the sampling area
  • Moves status changed materials to the proper location
  • Receives any non-inventory shipments and appropriately logs them
  • Operates forklifts, pallet jack, hand truck, carts, and pallet wrapper
  • Performs other duties as assigned
  • Provides guidance and supervision to direct reports during the course of day-to-day activities
WORK LOCATION: Kansas City, MO
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
11) MANAGER, FORMULATION, PROCESS DEVELOPMENT (Bryan, OH)
The Formulation and Product Development Manager is responsible for assisting Product Development, and supporting ANDA submissions to FDA in accordance with cGMP requirements, regulatory approvals, and current industry practices.
JOB REQUIREMENTS:
  • Works within project teams to lead product development of liquid / Suspension / and Semi-solid dosage forms. Development projects may include potent compound or DEA controlled substance as assigned.
  • Reviews data on developmental batches to determine appropriate steps to proceed and/or bring process improvements; writes scientific technical reports for regulatory filing.
  • Lead Planning and coordination of the technology transfer, scale-up and ANDA submission batches. Travels to other sites for the same if required.
  • Has knowledge of ICH Q1 Stability, Q6 Specifications, Q7 Good Manufacturing Practices, Q8 Product Development, Q9 Quality Risk Management.
  • Provide assistance to Technical Operations during scale-up and validation activities.
  • Provides technical input for FDA CMC deficiencies as required.
  • Leads strategic team within department, and participates on cross-functional teams.
  • Mentors team members to assist in achievement of objective as assigned.
  • Prepares and/or reviews written procedures and documentation, including SOPs, Master Batch Records, Master Packaging Records, Specifications, investigations, deviations and other related documents.
  • Prepares and/or reviews ANDA submissions, including PCN (Product Concept Notes), PDR (Product Development Reports) and QOS (Quality Overall Summary) by applying QBD (Quality by Design) principles and Quality Risk Management Assessments.
  • Coordinates with Analytical R&D, Quality Control, Microbiology and Regulatory Affairs departments in filing ANDAs and/or PAS (Prior Approval Supplements).
  • Coordinates with sales and marketing department to purchase essential inventory items, components, and equipment parts based on forecast.
  • Assists multi-disciplinary and multi-site teams to develop several products in parallel.
  • Participates in project management for cost estimation, project timelines, and resource needs.
  • Implements of all R&D projects.
  • Supports manufacturing processes through process development and process improvement efforts.
  • Performs other duties as assigned.
WORK LOCATION: Bryan, Ohio
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
12) TECHNICAL OPERATIONS MANAGER (Bryan, OH)
The Technical Operations Manager is responsible for ensuring that the Technical Operations Supervisor (Manufacturing) and Technical Operations Supervisor (Packaging), Validation Technicians, Maintenance, and Manufacturing and Packaging personnel fulfill their requirements and follow cGMP regulations. The Technical Operations Manager is the backup for all of these positions. The Technical Operations Manager is responsible for ensuring equipment utilized within the facility has been qualified prior to use, ensures all processes being used to produce approved drug products are valid, provides direction for current production schedule, obtains proper resources for the timely execution of the production schedule, and provides necessary information for the maintenance, modification or expansion of the facility in accordance to local code and necessary requirements for production.
JOB REQUIREMENTS:
  • Product Costing
  • Manufacturing, packaging and materials handling equipment and facilities
  • Manufacturing, Packaging and R&D System Implementation
  • Approval of Departmental SOP
  • Approval of Validation Protocols and Reports
  • Approval of Qualification Protocols and Reports
  • Approval of Material Reports
  • Approval of Rejection and Destruction Requests
  • Approval of Work Orders
  • Approval of MBRs, MPRs
  • Approval of Protocol Deviations
  • Approval of Preventative Maintenance Records
  • Approval of Cleaned Tags and Preparation of Solutions
  • Approval of Equipment Logs
  • Approval of Room Logs
  • Approval of Third Party Calibration
  • Approval of Deduction Cards
  • Approval of Chart Recorders
  • Approval of Training Forms
  • Approve equipment qualifications
  • Approve manufacturing and packaging validations
  • Approve raw materials and packaging components
  • Specify manufacturing, packaging and materials handling equipment
  • Specify and design facility improvements
WORK LOCATION: Bryan, Ohio
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
 
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