On-Site QA Supervisor

Scientific Protein Laboratories; Waunakee (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Medical, Dental & Vision on Day 1

Life and AD&D Insurance

Short and Long-term Disability

Health Savings Account

Employee Assistance Program

Generous vacation

Paid Holidays

401k

Advancement opportunities

Team-oriented environment

Community involvement

Company events

Job summary

Join Scientific Protein Laboratories (SPL) as an On‑Site QA Supervisor on the 1st shift in Waunakee, WI. The role leads the on‑site Quality Assurance team, ensuring cGMP-compliant QA activities including inspections, batch record reviews and materials release.

Responsibilities include maintaining QMS processes, reviewing investigations, deviations, CAPAs, change controls and participating in audits to support FDA/ICH/regulatory compliance.

Qualifications

• Associate degree required; bachelor’s degree preferred.
• 5+ years of QA experience in pharmaceutical manufacturing.
• 1st shift availability and leadership skills.

Responsibilities

• Oversee on-site QA staff, inspection of manufacturing/testing areas, release of raw materials, review of batch records.
• Organize the establishment/maintenance of relevant procedures/documents.
• Assist departments in identification and evaluation of facility events; ensure proper documentation.
• Determine disposition of packaging materials, in‑process materials and products per specs.
• Assist in preparation of Annual Product Review documentation for SPL products.
• Provide QA data and support for regulatory functions.
• Coordinate/review deviations, investigations, change controls and CAPAs.
• Participate in audits and address findings as needed.
• Perform intermediate and finished product release assessments; product shipping release.
• Drive continuous improvement of SPL cGMP Quality Systems for on-site QA.

Skills

Quality assurance

Leadership

Regulatory compliance

Documentation

GMP knowledge

Education

Associate’s degree

Bachelor’s degree preferred

Job description

Job Details

Job Location: Scientific Protein Laboratories - Waunakee, WI 53597

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. 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 and
• 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’ required, 10+ years preferred
• Schedule: 1st shift

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.