Manufacturing Documentation and Compliance Specialist
3 days ago
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OnsiteFull-timeEntry
Summary
Scientific Protein Laboratories, LLC is seeking a Manufacturing Documentation and Compliance Specialist to join their team in Waunakee, WI. The role involves supporting manufacturing operations by ensuring accurate documentation, data integrity, and coordination with Quality Assurance and Quality Control.
About the Role
As a Manufacturing Documentation and Compliance Specialist, you will serve as a liaison between Manufacturing and Quality for timely review and approval of documentation and investigations. Your responsibilities will include assisting in the drafting and closure of manufacturing deviations, supporting change controls, coordinating training documentation, and maintaining compliance with cGMP standards. You will also participate in internal audits and ensure the accuracy of manufacturing instructions and batch records.
About You
Required:
- High School Diploma or G.E.D. required.
- 2+ years of experience in a GMP-regulated manufacturing or documentation support role.
Preferred:
- Associate’s or Bachelor’s degree in a scientific, technical, or related field.
Benefits
- Competitive compensation.
- Excellent benefits package including Medical, Dental, and Vision on Day 1.
- Life and AD&D Insurance, Short and Long-term Disability.
- Health and Flexible Saving Account options.
- Employee Assistance Program.
- Generous vacation and paid Holidays.
- 401k with advancement opportunities.
- Team-oriented environment and community involvement.
Scientific Protein Laboratories, LLC
Scientific Protein Laboratories (SPL) has been a leading global supplier of high quality active pharmaceutical ingredients (APIs) for over three decades. We specialize in cGMP biopharmaceutical manufacturing and are among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. We serve the pharmaceutical, veterinary, and food industries globally. Our manufacturing facility is located in Waunakee, Wisconsin.
Waunakee, WI