Senior Analyst, Quality Control; Raw Materials
Job in
Bedford, Middlesex County, Massachusetts, 01730, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Role:
Senior QC Analyst specializing in raw material testing within a GMP-regulated pharmaceutical setting, primarily for ophthalmic product development using proprietary bioresorbable hydrogel technology.
Responsibilities:
- Perform and review complex analytical tests (HPLC, GC, XRPD, Karl Fischer)
- Lead investigations (OOS, OOT, deviations)
- Author SOPs and validate methods
- Coordinate external testing
- Support raw material qualification
- Mentor junior staff
Collaborates with QA, Manufacturing, Supply Chain, and external labs; participates in audits.
Qualifications:- Bachelor's in Chemistry, Biochemistry, or related
- 5+ years in GMP QC labs with expertise in analytical instrumentation
- Familiarity with pharmacopeial standards (USP, EP, JP)
- Experience with LIMS and validation activities
- Experience with regulatory submissions
- ICH/FDA guidelines
- Clean lab operations
- Continuous improvement initiatives
Laboratory setting with chemical exposure, PPE use required, occasional lifting up to 25 lbs.
High-Value Details:Focus on raw material qualification, analytical method validation, and GMP compliance; no specific therapeutic area beyond ophthalmic drug delivery.
Location and travel specifics are not provided.
Position Requirements
10+ Years
work experience
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