More jobs:
Quality Control Analyst , Raw Materials
Job in
Bedford, Middlesex County, Massachusetts, 01730, USA
Listed on 2026-09-12
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-12
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Position Summary
Quality Control (QC) Analyst I, Raw Materials is responsible for routine and non-routine testing of raw materials to ensure compliance with internal specifications, regulatory requirements, and industry standards. Performs analytical testing, documentation, and cross-functional collaboration to support manufacturing and supply chain operations.
Key Responsibilities- Perform qualitative and quantitative testing of raw materials using HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
- Review and interpret analytical data; ensure compliance with cGMP, USP, EP, JP, and other applicable standards.
- Support aliquoting, shipment, and coordination of outsourced testing at contract laboratories.
- Assist with QC incoming inspections and AQL activities for raw materials and finished products.
- Assist in preparation/review of SOPs, test protocols, test reports, test methods, and specifications.
- Perform method transfer, validation, and verification per ICH Q2 and cGMP guidelines.
- Investigate and document out-of-specification (OOS) results and deviations.
- Support raw material qualification and requalification.
- Collaborate with QA, procurement, warehouse, and manufacturing to resolve material-related issues.
- Participate in internal and external audits/inspections; ensure lab safety and environmental/regulatory compliance.
- Bachelor's degree in Chemistry, Biochemistry, or related scientific discipline.
- 1-3 years QC laboratory experience (regulated industry preferred).
- Proficiency with analytical techniques and instrumentation.
- Strong understanding of cGMP and GLP/regulatory guidelines.
- Excellent documentation/organizational skills; ability to work independently and in a team.
- Strong problem-solving/critical thinking.
- Experience with LIMS.
- Familiarity with compendial testing (USP, EP, JP).
- Knowledge of raw material lifecycle management.
Laboratory setting with chemicals and analytical instruments; occasional lifting up to 25 lbs; use of PPE as required.
Salary Range$68,000-$75,000 USD
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