Job Title: QC Sr. SpecialistJob Type: Long Term ContractLocation: Durham, NC (Onsite Role) Job Description:Support compliance and conformance to quality standards in manufacturing and production.
Key Responsibilities: - Coordinate QC activities and method transfers
- Support evaluations, documentation, and internal audits
- Perform trend analysis and review data for specification compliance
- Lead investigations (Deviation, OOS/OOT/OOE)
- Author and revise SOPs, reports, and protocols
- Oversee analytical projects and instrument problem-solving
- Support training and continuous improvement
Requirements: - Bachelors in Biochemistry, Biology, Microbiology, or related
- 8 years in GMP or 7 years at GTx
- Proficient in testing methods: ELISA, PCR, HPLC, CE, AUC, etc.
- Excellent communication and technical writing
Strong teamwork, problem-solving, and independent judgment