QA Specialist
7400 Gateway Boulevard Newark, CA 94560 US
Job Description
Responsibilities include, but are not limited to:
- Review production batch record for compliance to Good Documentation Practices and established SOPs/standards Initiate raw material and product disposition process
- Assist with QA retain inspections w/ QC and Sample Mgmt. Review and approve
- Certificate of Analysis and Certificate of Conformance for batch release
- Perform documentation review of media fills and media fill protocol approvals as needed
- Create / revise documents (SOPs/Forms/templates) as needed
- Support QMS processes including deviations, CAPAS and change controls
- Assist with training other individuals within the department
- Review specifications/ standards/ inspection plans for compliance to current regulatory requirements.
- Participate in audits as assigned by management
- Other duties as assigned by supervisor
Skills:Â Â Â
- Knowledge of quality systems and regulatory requirements including relevant US and EU guidelines
Education:Â Â Â
- Bachelor’s degree in related science or engineering field with at least 5 years of experience in GMP regulated biopharmaceutical manufacturing with preference for experience with gene and cell therapy products
Pay Rate Range: $40-58/hr. Salary will be commensurate with experience.
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