Quality Systems QA Manager
Scientific Protein Laboratories
Summary
Responsible for management of the site's Quality Systems including but not limited to cGMP training, investigations (including customer complaints), deviations, change controls and CAPAs. Develops and maintains cGMP-compliant Quality Management Systems. Responsible for management of SPL's quality compliance throughout SPL which includes operational activities such as: release of intermediate and finished product, review/coordination of investigations (including customer complaints), approval of deviations, change controls, and CAPAs; approval of validation/qualification documents; hosting of external agencies and/or customer audits. The manager is responsible for personnel activities such as: reviews, workload management and coordination of training.
Job description
Responsibilities Include:
- 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.
- 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 assure 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.
Requirements
- Associate's Degree, Bachelor's Degree in natural sciences or above preferred
- 10+ years of experience, 15+ years preferred
- History of developing Quality Systems' teams' skills with examples of coaching to goals, identifying strengths, mentoring, encouraging cross-functional collaboration
- Experience with professional, transparent compliance engagement with external authorities
- Demonstrate experience in inspection, inspection readiness, coordination, and proper documentation. Coaching team experts to speak on documents as needed.
- Experience in relationships with managing consultants
- Experience managing metrics reporting for technical aspects, navigating change control
- Experience managing the needs for annual product reviews, vendor audits
- Experience escalating issues to solve problems
- Coach sales to understand compliance
Benefits
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-term Disability
- Health & Flexible Saving Accounts
- Employee Assistance Program
- Generous Vacation
- Paid Holidays
- 401k
- Advancement Opportunities
- Team-oriented Environment
- Community Involvement
- Company Events
Company overview
Scientific Protein Laboratories (SPL) is a leading global supplier of high-quality active pharmaceutical ingredients (APIs) with over four decades of experience in the pharmaceutical manufacturing industry. Founded in 1976 in Waunakee, Wisconsin, the company specializes in cGMP biopharmaceutical manufacturing and is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. SPL serves pharmaceutical, veterinary, and food industries worldwide, operating manufacturing facilities in both Waunakee, Wisconsin and Sioux City, Iowa. The company focuses on extracting, isolating, and purifying naturally-derived materials from animal and plant sources, with particular expertise in porcine-sourced starting materials. As a subsidiary of Shenzhen Hepalink Pharmaceutical since 2014, SPL maintains a strong commitment to regulatory compliance and quality assurance, operating strictly in accordance with FDA's cGMP requirements while providing comprehensive regulatory support to its global customer base.