More jobs:
Senior Specialist II, Quality Control Validation
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-10-08
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-08
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist, Medical Science
Job Description & How to Apply Below
Role:
Senior Specialist II, QC Validation, overseeing method validation and validation readiness within Quality Control for cell and gene therapy manufacturing.
- develop validation strategies, protocols, and plans aligned with regulatory standards
- execute validation activities
- analyze data
- ensure compliance
- collaborate with Analytical Development, QC testing, QA, and customer teams
- support inspections and audits
- mentor supporting staff
- BS in Biology, Molecular Biology, Chemistry, or related field with 8+ years (or MS with 6+ years) in GMP QC
- expertise in gene and cell therapy assays like qPCR, ddPCR, flow cytometry, ELISA, cell-based assays
- strong GMP, SOP, and quality system knowledge
- data analysis skills
- experience with method validation for commercial products
- preferred experience in cell/gene therapy manufacturing and electronic systems (LIMS, QMS)
- cell and gene therapy
- validation
- GMP QC
- microbiology
- raw materials
- outsourcing
- regulatory compliance
Work Setup: not specified; physical requirements include standing and routine movements.
Position Requirements
10+ Years
work experience
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