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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 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
 
 
3) 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
 
 
4) 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
 
 
5) 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
 
 
6) 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
 
 
7) VALIDATION SCIENTIST I (Kansas City, MO)
The Validation Scientist I is responsible for supervising and assuring day-to-day activities in assigned manufacturing rooms or suites are carried out by direction and according to applicable procedures.
JOB REQUIREMENTS:
  • Supports validation and qualification of processes, facilities, equipment and cleaning procedures
  • Prepare protocols, perform field execution and prepare final report for engineering study/process validation for immediate and extended release dosage form
  • Prepare protocols, perform field execution and prepare final report for cleaning validation study/cleaning process validation
  • Performs cleaning verification swabbing
  • Performs or supervise equipment qualification (IQ, OQ, PQ and Commissioning)
  • Review validation, qualification and engineering study protocols
  • Execute Temperature (thermal) Mapping studies for stability chambers, stability room and warehouse
  • Troubleshoots process related problems and implement corrective actions
  • Provides input to develop and maintain current master production records
  • Prepare and revise validation SOPs, and equipment SOPs
  • Document process and protocol investigations/deviations and ensures all investigations/deviations are handled according to the approved procedure
  • Compile and analyze test information to determine process/equipment operating efficiency or to diagnose process/equipment malfunctions
  • Initiates change controls, as necessary
  • Performs verification based on ECC (Equipment Change Control) and DCC (Document Change Control)
  • Evaluate and assess change controls request, and provide validation assessment following validation SOPs
  • Train manufacturing associates on manufacturing processes and equipment SOPs when assigned to do so develop project plan, work with cross functional team and communicate project progress effectively
  • Reports cGMP violations to Floor Supervision attention
  • Assures compliance with NLI’s safety procedures and policies Participates in committees for improvements in pharmaceutical manufacturing operations
  • Ensure process and project documentation is accurate and updated
  • Performs other duties as assigned
WORK LOCATION: Kansas City, MO
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
8) 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
 
 
9) 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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