Quality Systems QA Manager

Job Details

Job Location:

Scientific Protein Laboratories - Waunakee, WI 53597

Position Summary

• Responsible for the functions associated with the Quality System, including oversight and coordination of training, investigations (including customer complaints), deviations, change controls, CAPAs and validation/qualification documents.
• Oversee the establishment/maintenance of relevant procedures/documents
• Compiles and communicates metrics associated with the Quality System to management as required.
• Administer and oversee the electronic quality management system (eQMS).
• Responsible for continuous improvement of SPL cGMP Quality Systems to support compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.
• Oversee external agency and customer audits, and responses to audit findings.
• Performs intermediate and finished product release, and shipping documentation review/approval.
• Responsible for the prompt, technically accurate and cGMP-compliant preparation of Annual Product Review documentation for all SPL Marketed Products.
• Writes customer related Quality Agreements and verifies SPL is compliant with the approved Quality Agreements (including customer notifications)
• Oversee the investigation of process deviations, product failures, customer complaints or facility incidents and assures proper documentation and investigation per established procedures. Approves minor deviations and related CAPAs.
• Participates in the Material Review Board including assessment of customer complaints. Participates in assigning and addressing all customer communications.

• Associate's Degree, Bachelor's Degree or above preferred
• 10+ years of experience, 15+ years preferred

Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

• 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.