On-Site QA Specialist
On-site Quality Assurance specialist at Scientific Protein Laboratories, a cGMP biopharmaceutical API manufacturer in Waunakee, WI (Mon-Fri, 8am-4:30pm). The role performs facility inspections, batch record review, raw material inspection/release, and writes deviations, investigations, change controls and CAPAs.
- Compensation
- Not disclosed
- Location
- Scientific Protein Laboratories - Waunakee, WI 53597
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- 2+ years
- Category
- Qa
- Posted
Must have
- Bachelor's Degree or above in a Scientific discipline or 2+ years QA experience in a regulated industry
- 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
Nice to have
- Bachelor's Degree or above in a Scientific discipline with 5+ years QA experience in a regulated industry
Full description
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 .
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. The 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 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 On-Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below.
Responsibilities include:
- 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.
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:
- Demonstrate a deep understanding of Quality and Quality systems