Scientific Protein Laboratories is a biopharmaceutical leader in the development and cGMP compliant 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 Compliance Specialist to join our growing team.

Responsible for management of SPL’s quality compliance throughout SPL which includes operational activities such as: release of product; review of batch records; approval of investigations, deviations, discrepancies, and CAPAs; oversight of vendor qualifications; hosting of external agencies and/or customer audits; handling customer communications; review of cGMP documentation; pest control; raw material inspections, and Material Review Board. This position supervises a team of 5-7 individuals, the supervisor is responsible for personnel activities such as: reviews, workload management and coordination of training.

• Oversee the functions of QA compliance staff to include but are not limited to sampling and release of raw materials, review of manufacturing and packaging batch records, and product release.
• Determine disposition of packaging materials, in-process materials and products on the basis of approved specifications.
• Responsible for the prompt, technically accurate and cGMP-compliant preparation of Annual Product Review documentation for all SPL Marketed Products. Provide appropriate data and QA support for SPL regulatory functions.
• Assurance/compliance for critical quality systems and material controls including audits of quality systems, suppliers and contractors.
• Oversee the Material Review Board including assessment of customer complaints.
• Facilitates investigation of process deviations and discrepancies, product failures, or facility incidents and assures proper documentation and investigation per established procedures. Approves all deviations, discrepancies and investigations. Approve all proposed and completed CAPA.
• Participate as a Core Team Member of the Material Review Board (MRB). Develop a monitoring and trending system which will serve to analyze key Material Quality Matters (MQMs) which are discussed in the Material Review Board (MRB).

Bachelor’s degree or above in a Scientific discipline. Associate’s degree in a relevant discipline with experience may be substituted for Bachelor’s degree education.

5+ years of experience required. SPL offers a competitive salary, a comprehensive benefits package and a pleasant work environment. 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.