SRG is seeking a QA Specialist for a client in Berkeley, CA.
This position is with a major pharma company, and qualified candidates should have a BS and 3+ years of related Quality Assurance experience in the biopharma industry.
- Serve as a SME, providing technical support for clinical batch manufacturing activities
- Review clinical batch production documentation
- Independently review, revise and approve clinical batch production documents (e.g. master batch records, Clinical Manufacture Facility's operational SOP, Change controls, Deviations etc.)
- Provides QA evaluation of discrepancies offering sound suggestions on improvement
- Train internal customers/stakeholders on QAD relevant activities
- Support internal and external inspections and audits.
- Revise SOPs or other QA & Compliance documents.
- Sign Certificate of Conformance (CoC) and Certificate of Analysis (CoA), if not required to be executed by an authorized person (AP).
- Review and approve manufacturing batch records (MBRs), standard operating procedures (SOPs), sample tables (STs) and laboratory control records and associated records, specifications, sampling plan, Inspection Plan.
- BS/BA in a scientific/technical discipline
- At least 6 years total of experience in the biopharma industry
- 3-4+ years of quality assurance / clinical manufacturing related experience
- Knowledge/experience with Lot Release, Quality Assurance, Quality Control, Engineering, or Manufacturing in a GMP regulated environment
- Previous work experience in a GMP environment and exposure to manufacturing records, testing reports and SOPs
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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