1 Year Contract
Waltham, MA (hybrid)
Shift : M-F 8AM - 4PM - Hybrid
Job Responsibilities
- Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substances, bulk drug product, drug product and clinical materials for use in clinical trials.
- Perform QA review and approval on SOPs, forms, WI, and other document types
- Reviews and approves Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities
Education & Qualifications
- Education : HS or AA degree, with 5+ years of experience; Bachelors and or 8+ years of experience
- 5+ years of experience must be in quality, (more experience welcomed)
- Reviews and Approves Analytical documents such as Test Methods, Test Method, Transfer Plans, and Assessments
Must Have :
- Industry Knowledge, only supports QC lab documentation, and testing - will not support manufacturing
- Review and approve analytical-related documents such as test methods, test methods, transfer plans, and assessments.
- Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substances, bulk drug products, drug products, and clinical materials for use in clinical trials.
- MS Office
Nice to Have :
- Veeva experience a plus!
- Experience as QA Lead on projects
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