Quality Systems QA Specialist

Scientific Protein Laboratories•Waunakee, WI

About The Position

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 a Quality Systems QA Specialist. This position is responsible for executing written procedures associated with Quality System QA responsibilities including but not limited to cGMP training, review of validation/qualification documents, investigations (including customer complaints), deviations, change controls and CAPAs. Assists the supervisor in personnel activities such as workload management and coordination of training.

Requirements

Bachelor’s degree or above in Scientific discipline with 2+ years Quality experience in the biopharma/pharmaceutical industry required.

Nice To Haves

Bachelor’s degree or above in Scientific discipline with 5+ years Quality experience in the biopharma/pharmaceutical industry preferred.
2+ years’ experience required, 5+ years’ experience preferred.

Responsibilities

Responsible for SPL’s training program, including GMP training and training documentation.
Reviews and approves validation/qualification documents.
Facilitates and reviews the investigation of process deviations, product failures, customer complaints or facility incidents and assures proper documentation and investigation per established procedures.
Reviews and evaluates SPL compliance with Quality Systems QA procedures.
Responsible for continuous improvement projects associated with Quality Systems QA procedures.
Oversees the preparation of the APR’s for all SPL marketed product.
Manages the Change Control Committee meetings, including Change Control status and follow through on timeliness.
Coordinates Audit activities, including but not limited to: o Review of vendor/supplier qualification reports o Coordination and scheduling of internal and external audits o Coordination of responses to internal and external audit observations
Participates in audits and addresses audit findings where necessary.