On-Site QA Supervisor

Scientific Protein Laboratories•Waunakee, WI

9d•Onsite

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 an On-Site QA Supervisor. This is a 1st shift position. This position is responsible for supervision of the sites on-site Quality Assurance responsibilities including but not limited to on-site inspection, batch record review and raw material inspection/release. Develops and maintains cGMP-compliant Quality Management Systems. Responsible for management of SPL's quality compliance throughout SPL which includes operational activities such as: release of intermediate product, release assessment of finished product; review of batch records; review of investigations, deviations, change controls and CAPAs; pest control; raw material inspections/release. The supervisor is responsible for personnel activities such as: reviews, workload management and coordination of training.

Requirements

Associate’s degree required
5+ years’ required experience

Nice To Haves

Bachelor’s degree or above preferred
10+ years preferred experience

Responsibilities

Oversee the functions of the on-site QA staff to include but are not limited to on-site inspection of manufacturing/testing areas, sampling and release of raw materials, pest control, review of manufacturing and packaging batch records
Organize the establishment/maintenance of relevant procedures/documents.
Assists all departments in the identification and evaluation of facility events. Assures proper documentation is initiated to capture the event.
Determine disposition of packaging materials, in-process materials and products on the basis of approved specifications.
Participates in the preparation of Annual Product Review documentation for all SPL Marketed Products.
Provide appropriate data and QA support for SPL regulatory functions.
Coordinates/reviews deviations, investigations, change controls and CAPAs
Participates in audits and addresses audit findings where necessary.
Performs intermediate product release and finished product release assessments.
Product shipping release.
Responsible for continuous improvement of SPL cGMP Quality Systems to support on-site QA in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.
Compiles and communicates metrics associated with on-site QA to management as required.