Operations On-Site QA Specialist

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 Operations On-site QA Specialist.

Under minimal supervision from senior team members, this position executes written procedures associated with on-site Quality Assurance responsibilities focusing on on-site inspection of manufacturing and testing operations.  The Operations On-Site QA Specialist will be introduced to the on-site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP QA setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the Operations On-Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below.

Work Schedule:

• This is a 12-hour day shift - 4 am to 4 pm
• Week 1: Sunday, Wednesday and Thursday
• Week 2: Monday, Tuesday, Friday and Saturday

Responsibilities include:

• Conducts on the floor reviews of all manufacturing and testing operations.
• Performs verifications required to support manufacturing and testing documentation (including but not limited to batch records, cleaning records, logbooks, and test methods).
• Assists all departments in the identification and evaluation of facility events.
• Performs on the floor reviews of executed batch records.
• Assists in the organization and/or the establishment/maintenance of relevant procedures/documents.
• Assists in audits where necessary.
• Supports the document control team in issuing records as needed.
• Performs other duties as assigned.

Job Requirements and Qualifications:

This position is open to candidates with a range of relevant experience levels. Candidates meeting the minimum qualifications are encouraged to apply. Final job level and compensation will be determined based on the selected candidate’s education, experience, skills, and overall qualifications.

Education:

• 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

Experience:

• 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

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.