On-Site QA Specialist

Job Details:

Job Location:

Scientific Protein Laboratories - Waunakee, WI, Salary Range:
Undisclosed, 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.

Schedule is Monday-Friday, 8am-4:30pm, with some flexibility.

• Assists all departments in the identification and evaluation of facility events. Assures proper documentation is initiated to capture the event.
• Reviews executed batch records.
• Perform inspection and disposition of raw materials on the basis of approved specifications.
• Writes deviations, investigations, change controls and/or CAPAs.
• Performs shipping release procedures.
• Assists in the preparation of Annual Product Review documentation for all SPL Marketed Products.
• Administrative support for the on-site QA department such as generation of DCR's, file organization, data compilation, training activities, etc.

• Required:
  
  Bachelor’s Degree or above in a Scientific discipline or 2+ years QA experience in a regulated industry
• Preferred:
  Bachelor's Degree or above in a Scientific discipline with 5+ years QA experience in a regulated industry

• Demonstrate a deep understanding of Quality and Quality systems
• Experience in cGMP in a pharma manufacturing facility
• 2 years’ experience in writing deviations and investigations
• 2 years’ conducting walk throughs using checklists
• Completing Control Document revisions
• Conducting Inspections
• Experience ensuring operators are adhering to safety procedures and company policies

Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

• 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.