- QC Analyst – Biologics |
- Location: CA
- Position Overview
- Our pharmaceutical client is seeking an experienced QC Analyst to support Quality Control testing for biologics manufacturing operations. The ideal candidate will have hands-on experience with analytical testing of biologic products, particularly ELISA and RiboGreen assays. Experience supporting mRNA products or RNA-based therapeutics is highly preferred.
- Key Responsibilities
- Perform routine QC analytical testing of biologic and mRNA-based products in a GMP laboratory environment.
- Execute ELISA assays for protein detection, quantification, and product-specific testing.
- Perform RiboGreen assays and similar fluorescence-based methods for RNA concentration and quantification.
- Conduct analytical testing of raw materials, in-process samples, drug substance, and/or finished products.
- Prepare samples, standards, reagents, buffers, and controls in accordance with approved SOPs and analytical procedures.
- Accurately review, record, and document analytical results in compliance with GMP, GDP, and data integrity requirements.
- Support laboratory investigations, deviations, OOS/OOT investigations, and analytical troubleshooting.
- Maintain laboratory equipment, instruments, and associated documentation in a compliant state.
- Collaborate closely with QC, QA, Manufacturing, and Analytical Development teams to meet testing and product-release timelines.
- Ensure all testing activities are performed safely, accurately, and in accordance with established procedures.
- Qualifications
- Hands-on QC analytical testing experience within biologics, biotechnology, or pharmaceutical manufacturing.
- Strong practical experience performing ELISA assays.
- Experience with RiboGreen assays or comparable fluorescence-based RNA/DNA quantification techniques.
- Experience supporting mRNA products, RNA therapeutics, or other biologic modalities strongly preferred.
- Working knowledge of GMP laboratory practices, data integrity, and Good Documentation Practices (GDP).
- Ability to independently execute analytical methods and troubleshoot laboratory testing issues.
- Experience supporting QC investigations, deviations, OOS/OOT events, and general laboratory operations preferred.
- Strong attention to detail, documentation skills, and ability to work effectively in a fast-paced manufacturing environment.
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QC Analyst – Biologics
United Pharma
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