JOB SUMMARY
Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Quality Systems QA Specialist.
This position is responsible for executing written procedures associated with Quality System QA responsibilities including but not limited to cGMP training, review of validation/qualification documents, investigations (including customer complaints), deviations, change controls and CAPAs. Assists the supervisor in personnel activities such as workload management and coordination of training.
Responsibilities include:
- Responsible for SPL’s training program, including GMP training and training documentation.
- Reviews and approves validation/qualification documents.
- Facilitates and reviews the investigation of process deviations, product failures, customer complaints or facility incidents and assures proper documentation and investigation per established procedures.
- Reviews and evaluates SPL compliance with Quality Systems QA procedures.
- Responsible for continuous improvement projects associated with Quality Systems QA procedures.
- Oversees the preparation of the APR’s for all SPL marketed product.
- Manages the Change Control Committee meetings, including Change Control status and follow through on timeliness.
- Coordinates Audit activities, including but not limited to:
o Review of vendor/supplier qualification reports
o Coordination and scheduling of internal and external audits
o Coordination of responses to internal and external audit observations
- Participates in audits and addresses audit findings where necessary.
Job Requirements and Qualifications:
Position will be filled up to the Senior level and determined at discretion of the hiring manager.
Education: Bachelor’s degree or above in Scientific discipline with 2+ years Quality experience in the biopharma/pharmaceutical industry required. Bachelor’s degree or above in Scientific discipline with 5+ years Quality experience in the biopharma/pharmaceutical industry preferred.
Experience: 2+ years’ experience required, 5+ years’ experience preferred.
WHY JOIN SPL?
Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.
Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!
SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
Skills Required
- Bachelor's degree in a Scientific discipline
- 2+ years quality experience in the biopharma/pharmaceutical industry
- 5+ years quality experience in the biopharma/pharmaceutical industry
- Knowledge of and experience working under cGMP
- Experience managing GMP training programs and training documentation
- Experience reviewing and approving validation and qualification documents
- Experience conducting investigations for deviations, product failures, and customer complaints
- Experience managing change control processes and Change Control Committee activities
- Experience managing CAPAs and continuous improvement projects related to Quality Systems
- Experience coordinating and participating in internal and external audits and responding to observations
- Experience preparing Annual Product Reviews (APRs)
What We Do
Scientific Protein Laboratories is a leading global supplier of high-quality active pharmaceutical ingredients (APIs). Specializing in cGMP biopharmaceutical manufacturing, the company is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. Based in Waunakee, Wisconsin, it serves the pharmaceutical, veterinary, and food industries globally.
