Scientific Protein Laboratories-posted 3 months ago
Full-time • Mid Level
Waunakee, WI
251-500 employees

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 Specialist. Under minimal supervision from senior team members, this position is responsible to execute written procedures associated with on-site Quality Assurance responsibilities including but not limited to on-site inspection, batch record review and raw material inspection/release.

  • Assist all departments in the identification and evaluation of facility events and assure proper documentation is initiated to capture the event.
  • Review executed batch records.
  • Perform inspection and disposition of raw materials on the basis of approved specifications.
  • Write deviations, investigations, change controls and/or CAPAs.
  • Perform shipping release procedures.
  • Assist in the preparation of Annual Product Review documentation for all SPL Marketed Products.
  • Provide administrative support for the on-site QA department such as generation of DCR's, file organization, data compilation, training activities, etc.
  • Bachelor’s degree or above required; Bachelor’s degree or above in Scientific discipline preferred.
  • 2 plus years of experience required; 5 plus years of experience preferred.
  • Competitive compensation
  • Excellent benefits package including Medical, Dental and Vision on Day 1
  • Life and AD&D Insurance
  • 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
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