Opportunity Description
Roles & Responsibilities:
- Performs work under general supervision.
- Provide quality, technical support and oversight during manufacturing activities.
- Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark.
- Open deviations as appropriate based upon Spark Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition.
- Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release.
- Review and evaluate QC testing records and any associated OOS investigations.
- Review, write, revise, and approve SOP's, technical documents, and reports.
- Perform inspection and release of materials used for production and review vendor certificates for completeness / co...
Ready to Apply?
Submit your application for Quality Assurance Specialist at Katalyst Healthcares & Life Sciences
Apply for this Position