Quality Assurance Supervisor API Pharmaceuticals
Job Description
Job Description
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. This is a 1st shift position.
This position is responsible for supervision of the sites on-site Quality Assurance responsibilities including but not limited to on-site inspection, batch record review, and raw material inspection/release. 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 product, release assessment of finished product; review of batch records; review of investigations, deviations, change controls and CAPAs; pest control; raw material inspections/release. The supervisor is responsible for personnel activities such as reviews, workload management and coordination of training.
Responsibilities include:
- Oversee the functions of the on-site QA staff to include but are not limited to on-site inspection of manufacturing/testing areas, sampling and release of raw materials, pest control, review of manufacturing and packaging batch records
- Organize the establishment/maintenance of relevant procedures/documents.
- Assists all departments in the identification and evaluation of facility events. Assures proper documentation is initiated to capture the event.
- Determine disposition of packaging materials, in-process materials and products on the basis of approved specifications.
- Participates in the preparation of Annual Product Review documentation for all SPL Marketed Products.
- Provide appropriate data and QA support for SPL regulatory functions.
- Coordinates/reviews deviations, investigations, change controls and CAPAs
- Participates in audits and addresses audit findings where necessary.
- Performs intermediate product release and finished product release assessments.
- Product shipping release.
- Responsible for continuous improvement of SPL cGMP Quality Systems to support on-site QA in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.
- Compiles and communicates metrics associated with on-site QA to management as required.
Job Requirements and Qualifications:
Education: Associate’s degree required, Bachelor’s degree or above preferred
Experience:
- 5 years experience 10+ years preferred in Pharmaceutical Quality Assurance, ensuring Quality Assurance cGMP procedure compliance
- Experience leading a team of QA professionals performing inspections of manufacturing and testing areas, sampling and release of raw materials, pest control, review of manufacturing and packaging batch records
- Experience preparing for Annual Product Reviews
- Experience coordinating and reviewing deviations, investigations, change controls and CAPAs
- Experience performing all Quality Assurance functions and creating continuous improvement in those functions
- Skilled in compiling and communicating metrics associated with on-site QA to management
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!
\nCompany 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-young 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 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-young 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.