Quality Control Chemist - I

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.