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 an Audit QA Supervisor.
This position is responsible for supervision of the sites Audit Quality Assurance responsibilities including but not limited to internal audits, vendor/supplier audits, customer audits and regulatory agency audits. Responsible for management of SPL's Audit QA group which includes operational activities such as: oversight of the internal audit program; oversight of vendor/supplier qualifications; hosting of external agencies and/or customer audits. The supervisor is responsible for personnel activities such as: reviews, workload management and coordination of training.
Responsibilities include:
- Responsible for the functions associated with the Audit QA group, including oversight and coordination of the internal audit program, vendor/supplier qualification program, customer audits and regulatory agency audits.
- Organize the establishment/maintenance of relevant procedures/documents.
- Review vendor/supplier qualification reports.
- Participate in the drafting and review of quality agreements with raw material suppliers.
- Coordinates and communicates responses to customer and regulatory agency audit observations.
- Oversee and maintain the audit module used within the electronic quality management system (eQMS).
- Responsible for continuous improvement of SPL cGMP Quality Systems to support audits in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.
- Participates in the preparation of Annual Product Review documentation for all SPL Marketed Products.
- Compiles and communicates metrics associated with audits to management as required.
Job Requirements and Qualifications:
- Education: Associate’s degree required, Bachelor’s degree or above preferred. ASQ Certification or equivalent preferred.
- Experience: 5+ years required, 10+ years 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.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: In person
