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Up to Lead Quality Assurance Compliance Specialist
Waunakee, WI
Job Description
Scientific Protein Laboratories is a biopharmaceutical leader in the development and manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation. We have an immediate opening in Waunakee, WI (Madison area) for a QA Compliance Specialist.
The QA Compliance Specialist develops and oversees execution of written procedures designed to ensure Good Manufacturing Practices (cGMP) compliance in such areas as batch production; record review and retention; and release of raw materials and product. This role conducts deviation/discrepancy investigations, product investigations and completes CAPAs. The QA Specialist also writes and reviews SOPs, logbooks, and product protection plans. This position is responsible for performing internal audits, assisting to write Annual Product Review and assists with internal company training.
DUTIES AND RESPONSIBILITIES
JOB REQUIREMENTS:
EOE
The QA Compliance Specialist develops and oversees execution of written procedures designed to ensure Good Manufacturing Practices (cGMP) compliance in such areas as batch production; record review and retention; and release of raw materials and product. This role conducts deviation/discrepancy investigations, product investigations and completes CAPAs. The QA Specialist also writes and reviews SOPs, logbooks, and product protection plans. This position is responsible for performing internal audits, assisting to write Annual Product Review and assists with internal company training.
DUTIES AND RESPONSIBILITIES
- Coordinates shipments for SPL, works closely with all departments to facilitate shipments.
- Mentors and trains new QA compliance staff.
- Actively participates as quality support in the manufacturing departments.
- Coordinates the review of batch records and releases product.
- Completes Deviations and CAPA's as needed.
- Serves as back up for various responsibilities as needed.
JOB REQUIREMENTS:
- Bachelor’s degree in Chemistry or related field required
- Requires 5 or more years of relevant experience
- Must have 2 or more years of experience in a pharmaceutical setting and a strong knowledge of cGMPs
- Demonstrated proficiency in technical writing and oral communication skills is required
EOE
Job Summary
Company
Start Date
12/15/2016
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
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