Operations On-Site QA Specialist, 1st (4am-4pm, 3 days on/2 days off/2 days on/ 3 days off)

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 Operations On-site QA Specialist

This position is responsible for Under minimal supervision from senior team members, executes written procedures associated with on-site Quality Assurance responsibilities focusing on on-site inspection of manufacturing and testing operations.

Responsibilities include:

• 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.
• 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:

Position will be filled up to the Lead level and determined at discretion of the hiring manager. 

Specialist     

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: Required: 2+ years, Preferred: 5+ years

Senior

Education: Required: Bachelor’s Degree or above in a Scientific discipline or 5+ years QA experience in a regulated industry, Preferred: Bachelor's Degree or above in a Scientific discipline with 7+ years QA experience in a regulated industry

Experience: Required:5+ years, Preferred: 7+ years

Lead

Education: Required: Bachelor’s Degree or above in a Scientific discipline or 7+ years QA experience in a regulated industry, Preferred: Bachelor's Degree or above in a Scientific discipline with 10+ years QA experience in a regulated industry

Experience: Required: 7+ years, Preferred: 10+ years

WHY JOIN SPL?

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