Job Title: QC Analyst / Laboratory Technician
Location: Durham, NC (100% Onsite)
Duration: 12 Months Contingent with possibility to convert to Full-time.
Job Summary
We are seeking a QC Microbiology Analyst to support laboratory testing activities within a pharmaceutical manufacturing environment. The ideal candidate will have experience in microbiological testing, environmental monitoring, GMP documentation, investigations, and quality systems.
Key Responsibilities
- Perform environmental monitoring of water, air, surfaces, and manufacturing areas.
- Conduct microbiological testing including sterility, bioburden, endotoxin, Gram staining, growth promotion, particulate count, and related assays.
- Support product release testing and quality control activities.
- Investigate laboratory deviations, out-of-specification results, and quality events.
- Participate in CAPA, root cause analysis, and corrective action activities.
- Maintain laboratory records and enter data into laboratory systems.
- Manage laboratory samples and ensure accurate documentation and tracking.
- Maintain laboratory inventory, supplies, reagents, and testing materials.
- Perform equipment qualifications, assay validations, and method verification activities.
- Follow GMP/cGMP requirements and laboratory SOPs.
Required Qualifications
- Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or related scientific discipline.
- 2–3 years of experience in a pharmaceutical, biotechnology, or GMP-regulated laboratory.
- Experience with laboratory investigations, deviations, CAPA, or root cause analysis.
- Hands-on experience with microbiological testing techniques.
- Strong documentation and data integrity skills.