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Quality Assurance Specialist
3 months ago
- Conduct batch record reviews and manage the release process
- Review completed or executed batch records and follow up on errors
- Attach supportive materials to the completed records
- Create and maintain error logs
- Review and validate completed raw material inventory cards
- Draft quality assurance procedures (such as SOPs) and provide support in driving the improvement programs in the Quality Assurance Team
- Review and approve of SOP's; provided consultation in development of new SOP's to ensure product development conforms with GXPs
- Review investigations and provide support in implementation of CAPAs as needed
- Review change control and ensure proper assessment is performed and action plan is documented to implement the change control
- Handle certificate of analysis and certificates of compliance
- Other duties as assigned
QUALIFICATIONS
- 4 years experience working within QA
- Prior experience working with a CMO preferred
- Bachelors Degree
