What are the responsibilities and job description for the Quality Systems QA Specialist position at Scientific Protein Laboratories?
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 a Quality Systems QA Specialist.
This position is responsible for executing written procedures associated with Quality System QA responsibilities including but not limited to cGMP training, review of validation/qualification documents, investigations (including customer complaints), deviations, change controls and CAPAs. Assists the supervisor in personnel activities such as workload management and coordination of training.
Responsibilities include:
o Review of vendor/supplier qualification reports o Coordination and scheduling of internal and external audits o Coordination of responses to internal and external audit observations
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Job Requirements and Qualifications:
Position will be filled up to the Senior level and determined at discretion of the hiring manager.
Education: Bachelor’s degree or above in Scientific discipline with 2 years Quality experience in the biopharma/pharmaceutical industry required. Bachelor’s degree or above in Scientific discipline with 5 years Quality experience in the biopharma/pharmaceutical industry preferred.
Experience: 2 years’ experience required, 5 years’ experience preferred.
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.