What are the responsibilities and job description for the Quality Control Chemist - I position at Unicon Pharma Inc?
Job Title: Quality Control Chemist
Location: Frederick, MD (Onsite)
Shift: Wednesday–Saturday, 3:00 PM–1:30 AM EST
Note: First 7 weeks require Monday–Friday, 7:30 AM–4:00 PM for onboarding and training.
Key Responsibilities:
- Perform QC testing of raw materials, intermediates, and finished products using Flow Cytometry, ELISA, qPCR, and cell-based bioassays.
- Review and trend test data, maintain GMP documentation, and support product release and Certificates of Analysis (CoAs).
- Maintain lab instruments, calibration, and routine maintenance.
- Write and revise SOPs, validation protocols, and reports.
- Support OOS investigations, deviations, and root cause analysis.
- Ensure GMP compliance, review procedural changes, and support continuous improvement.
Basic Qualifications:
- Bachelor’s degree; OR Associate degree with 2 years of relevant biotechnology and QC experience; OR High school diploma with 3 years of relevant experience.
Preferred Qualifications:
- Strong knowledge of GMP, SOPs, QC processes, and OOS investigations.
- Hands-on experience with Flow Cytometry, ELISA, PCR/qPCR, and cell-based assays.
- Knowledge of regulatory requirements (21 CFR Parts 11, 210, and 211).
- Proficiency in MS Office and strong communication skills.
- Preferred experience in the biotechnology or pharmaceutical industry.