Quality Assurance Specialist

Job Description

Job Description

Quality Assurance Specialist

Job Description

Join a growing Quality Assurance team where you'll play a critical role in maintaining compliance, product quality, and regulatory standards within a pharmaceutical manufacturing environment. This position offers exposure to quality systems, investigations, documentation review, and cross-functional collaboration while supporting continuous improvement initiatives.

Responsibilities

• Review and approve batch records, quality documentation, and raw materials.
• Manage deviations, investigations, CAPAs, and change controls.
• Perform product release and shipping release activities.
• Support Annual Product Reviews and other quality system initiatives.
• Maintain document control and ensure records are audit-ready.
• Utilize electronic quality management systems (eQMS) to manage quality events and workflows.
• Coordinate QA training activities and maintain training records.
• Partner with production, quality, and regulatory teams to ensure compliance with GMP and FDA requirements.

Qualifications

• 2+ years of Quality Assurance experience in a regulated industry (5+ years for higher-level consideration).
• Experience with batch record review, deviations, CAPAs, investigations, and change controls.
• Working knowledge of GMP, FDA, and quality system requirements.
• Strong attention to detail, organization, and documentation skills.
• Experience with electronic quality management systems (eQMS) preferred.
• Bachelor's degree in a scientific discipline preferred.

Why Apply?

• Direct impact on product quality and regulatory compliance.
• Exposure to a broad range of QA systems and processes.
• Collaborative, team-focused environment.
• Opportunity for professional growth and advancement within Quality.
• Stable pharmaceutical environment with long-term career potential.

Work Environment

This is an office-based Quality Assurance role within a regulated pharmaceutical manufacturing environment. You'll work closely with cross-functional teams while helping maintain quality systems, support audits, and ensure products meet the highest standards of compliance and quality.

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

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

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k

This is a fully onsite position in Waunakee,WI.

This position is anticipated to close on Sep 7, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.