A pharmaceutical company is actively seeking a new QC Analyst 2 to support the gene therapy program pipeline through the execution of GMP microbiological assays.
Responsibilities:
- Perform routine Quality Control microbiology testing of product and water samples
- Test bioburden, plate reading, endotoxin, total organic carbon, conductivity and media growth promotion
- Conduct reviews of GMP analytical data
- Support routine laboratory operations (data management, equipment cleaning, laboratory cleaning, inventory control and logbook management)
- Ensure laboratory operational readiness and assists with troubleshooting/continuous improvement as needed
- Revise SOPs, forms, protocols, data reports, and other controlled documents relating to QC microbiology testing and instrumentation
- Perform peer review of both internal and externally generated data, as needed
- Support QC deviations, investigations, root cause analysis, change control, and CAPA as needed
Qualifications:
- BS or MS in Microbiology or a related discipline with 2+ years industry experience. QC GMP experience is required
- Hands-on experience with performing microbiological analytical testing (bioburden, endotoxin, TOC, etc..) required
- Independently motivated and detail-oriented with good problem-solving ability
- Strong oral and written communication skills with clear penmanship
- Proficient in the use of computerized systems
- Experience with Excel and Microsoft Word
- Ability and desire to work in a fast-paced, start-up environment
- Strong collaboration skills
- Shift: 9:30 AM – 6:00 PM, Monday – Friday
- Flex hours and occasional weekend work
