Quality Assurance Specialist

Quality Assurance Specialist

The QA Specialist will primarily be active on the production floor, supporting the operations team with verifications, conducting walkthroughs, and performing onsite reviews and mini audits to ensure compliance with operational standards. This role involves identifying and resolving issues, such as initiating deviations, and includes responsibilities like reviewing documents, executed batch records, cleaning records, and logbooks, as well as issuing batch records when necessary. The position demands 80-85% of time spent on the floor, with the remainder in the office. The role also requires adherence to specific gowning requirements, ranging from safety shoes to full gowning.

Support the operations team by performing verifications and walkthroughs on the production floor.

Conduct onsite reviews and mini audits to ensure compliance with established standards.

Initiate deviations and propose solutions to identified problems.

Review and manage documents, including executed batch records, cleaning records, and logbooks.

Issue batch records as needed.

Comply with specific gowning requirements in designated areas.

Experience in quality assurance within a regulated industry.

Familiarity with GMP, FDA, and ISO standards.

Proficiency in batch record review, document control, and CAPA.

Ability to conduct audits within the pharmaceutical sector.

Bachelor's degree in any science discipline preferred.

For Specialist: Minimum of 2+ years of experience in a regulated industry.

For Senior: Minimum of 5+ years of experience in a regulated industry.

For Lead: Minimum of 7+ years of experience in a regulated industry, with potential to supervise or lead.

The work environment involves extensive time on the production floor and requires adherence to gowning protocols. The schedule is night shifts in a rotating pattern of 3 on/2 off/2 on/3 off, from 4pm to 4am. The role includes training on the 1st shift, Monday to Friday from 8 am to 4:30 pm, lasting 6-8 weeks. Employees are eligible for schedule incentives and a third shift differential.

The pay range for this position is $62000.00 - $90000.00/yr.

Medical, dental, 401K, vision

This is a fully onsite position in Waunakee,WI.

This position is anticipated to close on Sep 5, 2025.