Quality Systems QA Specialist

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:
• •      Review of vendor/supplier qualification reports
  •      Coordination and scheduling of internal and external audits
  •      Coordination of responses to internal and external audit observations
• Participates in audits and addresses audit findings where necessary.

Job Requirements and Qualifications:

This position is open to candidates with a range of relevant experience levels. Candidates meeting the minimum qualifications are encouraged to apply. Final job level and compensation will be determined based on the selected candidate’s education, experience, skills, and overall qualifications.

Required:

• Bachelor’s degree or above in Scientific discipline with 2+ years Quality experience in the biopharma/pharmaceutical industry. 

Preferred:

• 5+ years Quality experience in the biopharma/pharmaceutical industry 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, a Hepalink Company, creates the Active Pharmaceutical Ingredients Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. We serve the pharmaceutical, veterinary, and food industries globally. We specialize in cGMP biopharmaceutical manufacturing. Within the still-young biopharmaceutical industry, we are among a small group of companies with an established track record in efficient process development, analytical testing, quality assurance, and regulatory support required to provide our customers with cGMP compliant APIs at all phases of clinical development, straight through to commercial launch.