On-Site QA Specialist
Scientific Protein Laboratories
Summary
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.
Job description
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
- 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
Requirements
- Bachelor’s Degree or above in a Scientific discipline or 2+ 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
Benefits
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-term Disability
- Health & Flexible Saving Accounts
- Employee Assistance Program
- Generous Vacation
- Paid Holidays
- 401(k)
- Advancement Opportunities
Company overview
Scientific Protein Laboratories (SPL) is a leading global supplier of high-quality active pharmaceutical ingredients (APIs) with over four decades of experience in the pharmaceutical manufacturing industry. Founded in 1976 in Waunakee, Wisconsin, the company specializes in cGMP biopharmaceutical manufacturing and is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. SPL serves pharmaceutical, veterinary, and food industries worldwide, operating manufacturing facilities in both Waunakee, Wisconsin and Sioux City, Iowa. The company focuses on extracting, isolating, and purifying naturally-derived materials from animal and plant sources, with particular expertise in porcine-sourced starting materials. As a subsidiary of Shenzhen Hepalink Pharmaceutical since 2014, SPL maintains a strong commitment to regulatory compliance and quality assurance, operating strictly in accordance with FDA's cGMP requirements while providing comprehensive regulatory support to its global customer base.