Quality Systems Specialist
Job Details
Experienced
Scientific Protein Laboratories - Waunakee, WI
2 Year Degree
Pharmaceutical
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.

 

To Assure SPL maintains a strong quality system by ensuring deadlines are met, tasks are completed accurately the first time and mistakes have appropriate corrective and preventative actions put in place so they are not repeated. Follows and maintains SPL's procedures designed to ensure current Good Manufacturing Practice (cGMP) compliance. Prepares and maintains trend reports.

 

RESPONSIBILITIES

 

  • Assists in drafting, reviewing, and closing Deviations, CAPAs, and Change Controls
  • Assists in preparation of the APR's
  • Assists with GMP training
  • Assists in customer/regulatory agency audits
  • Tracks and trends metrics for the Quality Systems Department
  • Assists with external audits (i.e., customers, FDA)
  • Coordinates/leads the Change Control Committee
  • Assist with administration of the Electronic Quality Management System (EQMS)
Qualifications

Associate’s Degree required, Bachelor’s Degree or above in a Scientific discipline preferred.

5+ years’ experience required, 10+ preferred.

Experience with MasterControl preferred.

 

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.

 

 

#zr

Apply