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Career Opportunities
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Career Opportunities
 
POSITIONS AVAILABLE:
 
1) DIRECTOR, QUALITY
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
Bachelor’s Degree in Chemistry, Pharmacology, Pharmaceutics or related field with 8-12 years experience in pharmaceutical, biotech and/or medical device and supervisory experience required. Master’s 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  
 
 
2) 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  
 
 
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) SCIENTIST II (Kansas City, MO)
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.
JOB REQUIREMENTS:
  • 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 ARFs and CoAs.
  • 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.
WORK LOCATION: Kansas City, MO
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
5) MAINTENANCE ELECTRICIAN I (Kansas City, MO)
The Maintenance Electrician is responsible for performing skilled level electrical work in the installation, alteration, maintenance, and repair of electrical systems, equipment, and fixtures in accordance with standards and practice of the electrical trade.
JOB REQUIREMENTS:
  • Installs and repairs electrical systems, apparatus, and electrical and electronic components of pharmaceutical machinery and equipment, following electrical code, manuals, schematic diagrams, blueprints, and other specifications, using hand tools, power tools, and electrical electronic test equipment.
  • Diagnoses malfunctioning apparatus, like transformers, motors, and lighting fixtures, using test equipment, and replaces damaged or broken wires cables, using hand tools.
  • Follows gowning SOP when entering production area.
  • Mounts and connects auxiliary, mechanical, electrical, electronic, pneumatic or hydraulic equipment.
  • Installs moving parts, such as shafts, levers, or bearings, and tests free movement.
  • Replaces faulty electrical components of machines, like relays, switches, and motors, and positions sensing devices, using hand tools.
  • Provides preventative maintenance for pharmaceutical equipment.
  • Connects power supply wires to machines & equipment and connects cables and wires between machines and equipment, following manuals, schematic diagrams and blueprints, using hand tools test equipment.
  • Troubleshoots and repairs PLC and control logic on pharmaceutical equipment.
  • Uses reliability technologies to identify equipment that is not working within specifications.
  • Proficient with the use of power tools, hand tools, and shop equipment.
  • Troubleshoots equipment issues, adjusting, repairing, or replacing parts.
  • Works safely with electricity, steam, compressed gasses, chemicals and mechanical moving parts.
  • Installs power supply wiring and conduit for newly installed machines & equipment, like conveyors and programmable controllers, following electrical code and blueprints, using hand tools voltage tester.
  • Must be able to work in a cGMP facility utilizing Good Documentation Practice while completing Work Orders, Log Books, CAPA’s, ECC’s, & all other regulated forms.
  • Follows & enforces all SOPS and regulations in the Maintenance & Engineering department.
  • Replaces faulty electrical components of machine, like relays, switches, and motors, and positions sensing devices, using hand tools.
  • Tests malfunctioning machinery, using test equipment, and discusses malfunction with other maintenance workers.
  • May be required to hold electricians license.
  • Performs other duties as assigned.
WORK LOCATION: Kansas City, MO
APPLICANTS:
Send resume to: hrinfo@nostrumlabs.com
 
 
 
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