Quality Systems QA Manager in Waunakee

Energy Jobline ZR; Waunakee (WI); Vor Ort; USD 110.000 - 190.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Medical, Dental and Vision on Day 1

Life and AD&D Insurance

401k; advancement opportunities

Paid Holidays

Zusammenfassung

Join Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals located just outside Madison, Wisconsin in Waunakee. The On-Site QA Supervisor will lead the Quality System, including investigations, CAPAs, change controls, and regulatory compliance to support FDA/ICH and other pharma requirements.

Responsibilities include overseeing eQMS, product release, audit preparedness, and continuous improvement of cGMP Quality Systems, along with personnel training and workload

Qualifikationen

• Associate's or Bachelor's degree or higher required.
• 10+ years experience in QA; 15+ years preferred.

Aufgaben

• Manage Quality System functions including training, investigations, deviations, change controls, CAPAs and validation/qualification documents.
• Oversee procedures and documents; administer eQMS.
• Prepare and communicate Quality System metrics to management.
• Oversee external audits and responses to audit findings.
• Perform product release review and shipping documentation approval.
• Prepare Annual Product Review documentation for SPL marketed products.
• Draft and verify customer quality agreements and ensure SPL compliance.

Kenntnisse

Quality Assurance

Regulatory knowledge

Auditing

Ausbildung

Bachelor's degree or higher

Tools

eQMS system

Jobbeschreibung

Job DescriptionJob Description

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 On-Site QA Supervisor.

Shift: 1st Shift

Responsible for management of the sites 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.

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.
• 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.

Requirements:

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

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 ; 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!

Company Description

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- 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.

Company DescriptionSPL, 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- 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.