What are the responsibilities and job description for the Quality Control Sr. Scientist/Supervisor position at STC Biologics Inc?
About Us
We are a boutique biologics CDMO located in Newton MA . We are looking for self driven QC expert with technical expertise in biologics who will have end-to-end ownership of QC and EM investigations ensuring they are scientifically rigorous, risk-based, and inspection-ready
Key Responsibilities:
- Own and close deviations, OOS/OOT, and EM investigations
- Lead root cause analysis and determine appropriate CAPAs
- Assess analytical, microbiological, and biological variability
- Interface directly with QA and cross-functional stakeholders
- Defend the investigation conclusion
- Drive consistency and continuous improvement in investigation practices
Qualifications:
- BS in Chemistry, Biochemistry, or related field (MS preferred)
- 6–8 years GMP experience with ≥3 years owning investigations
- Strong background in biologics QC and microbiology/EM investigations
- Direct experience in supporting inspections
- Demonstrated ability to make independent, science-based decisions