QA Compliance Specialist
Job Details
Scientific Protein Laboratories - Waunakee, WI
Full Time
4 Year Degree
Day
QA - Quality Control
Description

Scientific Protein Laboratories is a biopharmaceutical leader in the development and cGMP compliant 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 to join our growing team.

 

This position is responsible for developing and overseeing 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. The QA Compliance Specialist conducts deviation/discrepancy investigations, product investigations and completes CAPAs as necessary. The role also includes writing and reviewing SOPs, logbooks, and product protection plans. In addition, the QA Compliance Specialist performs internal audits as necessary, assists in writing Annual Product Review and assists in internal company training.

 

Responsibilities

 

• Oversees and coordinates investigations, provides direction and guidance for investigations and executes them when needed.  

• Reviews completed batch records for completeness, accuracy and compliance to process parameters.

• Actively participates as quality support in the manufacturing departments.

• Supports SPL and participates in quality related training initiatives.

• Completes Deviations and CAPA's as needed.

• Serves as a back up for various responsibilities as needed

Qualifications
  • Bachelor's degree or above in Chemistry, Biological Sciences, or related discipline required. Associate’s degree in a relevant discipline with experience may be substituted for Bachelor’s degree education.

  • 2+ years of dedicated QA experience required. Relevant experience includes working in the pharmaceutical or other similar industry and working on routine review and release, investigation and audit support, participating in investigations, deviations, CAPAs, change controls or other document changes.

SPL offers a competitive salary, a comprehensive benefits package and a pleasant work environment.

 

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.

 

 


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