Quality Assurance Specialist

Quality Assurance Specialist

The Quality Assurance Specialist supports production operations by spending the majority of their time on the manufacturing floor, performing verifications, walkthroughs, onsite reviews, and mini audits to ensure processes follow established procedures and regulatory requirements. This role also reviews and issues critical documentation, such as executed batch records, cleaning records, and logbooks, and helps identify and implement solutions when issues arise, including initiating deviations and supporting CAPA activities.

The position combines hands-on floor presence with office-based documentation review and reporting.

Responsibilities:

• Spend approximately 60–70% of working time on the production floor supporting operations and verifying that activities comply with established procedures and quality standards.
• Conduct routine walkthroughs of production areas to observe operations, identify potential issues, and ensure processes occur as intended.
• Perform onsite reviews and mini audits to confirm adherence to GMP, FDA, ISO, and internal quality requirements.
• Collaborate with operations personnel to identify problems, propose solutions, and help initiate deviations when necessary.
• Review executed batch records, cleaning records, logbooks, and other quality-related documents for accuracy, completeness, and compliance.
• Issue batch records as needed to support production activities and ensure proper documentation is in place before manufacturing.
• Document findings from floor walkthroughs, reviews, and audits, and report observations to appropriate stakeholders in a clear and timely manner.
• Support CAPA and document control activities related to quality events, deviations, and audit findings, as needed.
• Follow area-specific gowning and safety requirements, ranging from safety shoes to full gowning, depending on the production area.
• Use electronic quality management systems (EQMS) and other office tools to manage documentation, track activities, and maintain records.

Additional Skills &

Qualifications:

• Bachelor's degree in any science discipline preferred.
• Experience in pharmaceutical manufacturing or a similar regulated production environment preferred.
• Familiarity with FDA regulations and pharmaceutical quality systems preferred.
• 0–2+ years of experience in a regulated industry environment such as GMP, FDA, or ISO-regulated operations.
• Experience or familiarity with batch records, batch record review, and document control practices.
• Ability to work 12-hour shifts on a rotating schedule, including overnight hours for third shift.

Work Environment:

This is an on-site role based primarily on the production floor, with the majority of time spent in manufacturing areas and the remainder in an office setting for documentation and reporting. Current openings are on third shift. New hires begin on first shift (Monday–Friday, 8:00 a.m. to 4:30 p.m.) for approximately 6–8 weeks of training, with efforts made to have team members on the same shift train together.

The environment includes time on the production floor and time in an office area outside of production, with regular interaction with an electronic quality management system (EQMS) and other office tools.

Job Type &

Location:

This is a Permanent position based out of Waunakee, WI.

Pay and Benefits:

The pay range for this position is $62000.00 - $72000.00/yr. Eligible for Medical, Dental and Vision on day 1 of employment. The company provides Basic Life insurance, Basic AD&D insurance along with Short-term disability on all full-time employees. Employees have the option to elect Voluntary Life, Voluntary AD&D along with Long-term disability coverage. Health and Flexible spending account options. Full-time employees can contribute to their 401k upon hire and are eligible for a company contribution.

Annually, the company offers 160 hours of vacation & 40 hours of sick time (both pro-rated base on hire date) and 9 paid holidays.

Workplace Type:

This is a fully onsite position in Waunakee, WI.

Final date to receive applications:

This position is anticipated to close on Jul 31, 2026.