On-Site QA Specialist

Scientific Protein Laboratories•Waunakee, WI

3d•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 Specialist. Schedule is Monday-Friday, 8am-4:30pm, with some flexibility. Under minimal supervision from senior team members, this position is responsible to execute written procedures associated with on-site Quality Assurance responsibilities including but not limited to on-site inspection, batch record review and raw material inspection/release. The On-Site QA Specialist will be introduced to the on-site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the On-Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below.

Requirements

Bachelor’s Degree or above in a Scientific discipline or 2+ years QA experience in a regulated industry
Demonstrate a deep understanding of Quality and Quality systems
Experience in cGMP in a pharma manufacturing facility
2 years’ experience in writing deviations and investigations
2 years’ conducting walk throughs using checklists
Completing Control Document revisions
Conducting Inspections
Experience ensuring operators are adhering to safety procedures and company policies

Nice To Haves

Bachelor's Degree or above in a Scientific discipline with 5+ years QA experience in a regulated industry

Responsibilities

Assists all departments in the identification and evaluation of facility events.
Assures proper documentation is initiated to capture the event.
Reviews executed batch records.
Perform inspection and disposition of raw materials on the basis of approved specifications.
Writes deviations, investigations, change controls and/or CAPAs.
Performs shipping release procedures.
Assists in the preparation of Annual Product Review documentation for all SPL Marketed Products.
Administrative support for the on-site QA department such as generation of DCR's, file organization, data compilation, training activities, etc.