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QC Microbiology/Bioassay Specialist
Treyburn, NC, NC 27712 United States
Scope of Position:
• The position requires good technical working knowledge of microbiological and cell-based assay/bioassay techniques. Assay validation, routine testing and assay optimization skills are highly preferred. The ability to detect and remedy problems within a cell or microbial assay is very important. Experience with the following cell lines is a benefit; CHO, A172, PANC-1, HT-1080, Ecopack, MRC-5, BHK.
• Proper handling, cell viability/maintenance and passaging of cell lines is vital, including cryogenic freezing methods. These cell lines are to be used in assays for the release of specialty products.
• Microbiology release testing, such as endotoxin, bioburden, sterility testing experience is also desired but secondary to cell based assay experience.
• This position interacts with all functional groups within Manufacturing and Sterilization.
Day to Day Responsibilities:
• Develops, designs and writes assay validations, equipment validations and standard operating procedures (SOP) for products, facility monitoring samples and equipment.
• Schedules/coordinates/performs assigned projects, compiles test data, writes summary reports and final reports.
• Leads setting up new microbiology laboratory assays/methods (test method validation). Performs method transfer and method validation reports
• Performs specified testing of raw materials, intermediates, components, and finished goods submitted to the laboratory for analysis to determine the acceptability of the material/product.
• Review test data to ensure results meet all specifications and input data (as applicable)
• Performs cell line maintenance, passaging for testing of finished products to determine the functionality of the finished product.
• Provide technical guidance and educational training to manufacturing in the area of microbiological testing, environmental and aseptic practices.
• Work closely with the Laboratory Supervisor to review technical problems, suggest solutions and anticipate major problems to key operations.
• Perform and report trend analyses of laboratory test results, lot failures, DHR review and product release.
• Assists/performs internal audits, if required.
• Perform other tasks as assigned.
Travel Requirements: Customer visits, training, etc.
Hours of work/work schedule/flex-time: 24/7 manufacturing environment, M-F position
Required Education: BS degree in Microbiology (preferred) or in the Biological Sciences
Required Years and Area of Experience: Minimum of 4 years of experience in Microbiology.
• Good understanding of cell assays, liquid and dehydrated media manufacturing process, aseptic techniques, sterile fill process, sterilization processes and systems
• Knowledge of microbial, bioburden determination assays and methodologies.
• Strong in application of technical principles, practices and procedures. Effective skills in analytical thinking and problem solving. Attention to detail is required
• Strong knowledge and understanding of quality system regulations/requirements (i.e. ISO 9001, ISO 11137, ISO 13485, ISO 14644, 21 CFR Part 210/211, Part 820, cGMP/GLP or USP requirements).
Soft Skills (Communication/Team/Leadership):
• Effective communication skills at all levels both written and verbal.
• Ability to perform multiple tasks and ability to effectively manage conflict.
• Ability to work in teams to obtain results by effectively influencing others, self-motivated/directed, ability to organize activities, minimal supervision required.
North Carolina Biotechnology Center