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QA Specialist
Waunakee, WI
Job Description
Scientific Protein Laboratories is a biopharmaceutical leader in the development and manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation. We have an immediate opening in Waunakee, WI (Madison area) for a QA Specialist to support R&D programs.
This position assists in developing, implementing and maintaining a specialized Quality System to support the R&D programs including quality assurance for GMP and GLP supplies. The R&D QA Specialist assists in the technical transfer of products to SPL. They ensure Good Manufacturing Practices (cGMP) compliance in such areas as batch production and record review and retention. This position conducts deviation/discrepancy investigations, product investigations and completes CAPAs as necessary. The R&D QA Specialist writes and reviews SOPs, logbooks, and product protection plans and assists with customer inquiries. They also perform internal audits as necessary, and backs up the Manager, R&D QA and Customer Support when necessary.
Responsibilities
Requirements
This position assists in developing, implementing and maintaining a specialized Quality System to support the R&D programs including quality assurance for GMP and GLP supplies. The R&D QA Specialist assists in the technical transfer of products to SPL. They ensure Good Manufacturing Practices (cGMP) compliance in such areas as batch production and record review and retention. This position conducts deviation/discrepancy investigations, product investigations and completes CAPAs as necessary. The R&D QA Specialist writes and reviews SOPs, logbooks, and product protection plans and assists with customer inquiries. They also perform internal audits as necessary, and backs up the Manager, R&D QA and Customer Support when necessary.
Responsibilities
- Oversees and coordinates investigations, provides direction and guidance for investigations and executes them when needed.
- Provide Quality Systems support for complex technical projects and in troubleshooting activities.
- Assist with CDMO and product technical transfers to commercial state.
- Assist in building, maintaining and continuously improving a specialized quality system to support R&D and CDMO programs.
- Answers customer communications and helps build a customer support program.
- Reviews completed batch records for completeness, accuracy and compliance to process parameters.
- Actively participates as quality support to R&D and the manufacturing departments that is performing the technical transfer.
- Supports SPL and participates in quality related training initiatives.
- Completes Deviations and CAPA's as needed.
- Serves as a back up for various responsibilities as needed.
Requirements
- Bachelor's Degree in Chemistry or related field highly preferred
- 5 or more years of relevant experience
SPL offers a competitive salary, a comprehensive benefits package and a pleasant work environment.
EOE
Job Summary
Company
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
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