Quality Control Chemist - I

Job Description

Job Title: Quality Control Chemist

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Location: Frederick, MD (Onsite)

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Shift: Wednesday–Saturday, 3:00 PM–1:30 AM EST

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Note: First 7 weeks require Monday–Friday, 7:30 AM–4:00 PM for onboarding and training.

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Key Responsibilities:

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• Perform QC testing of raw materials, intermediates, and finished products using Flow Cytometry, ELISA, qPCR, and cell-based bioassays.
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• Review and trend test data, maintain GMP documentation, and support product release and Certificates of Analysis (CoAs).
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• Maintain lab instruments, calibration, and routine maintenance.
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• Write and revise SOPs, validation protocols, and reports.
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• Support OOS investigations, deviations, and root cause analysis.
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• Ensure GMP compliance, review procedural changes, and support continuous improvement.
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Basic Qualifications:

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• 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.
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Preferred Qualifications:

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• Strong knowledge of GMP, SOPs, QC processes, and OOS investigations.
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• Hands-on experience with Flow Cytometry, ELISA, PCR/qPCR, and cell-based assays.
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• Knowledge of regulatory requirements (21 CFR Parts 11, 210, and 211).
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• Proficiency in MS Office and strong communication skills.
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• Preferred experience in the biotechnology or pharmaceutical industry.
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