Job Description
Job DescriptionQuality Assurance SpecialistAbout the Role
We are seeking a detail-oriented Quality Assurance Specialist to support quality systems, compliance initiatives, and continuous improvement efforts within a regulated manufacturing environment. This role is responsible for ensuring adherence to GMP, FDA, and ISO requirements through batch record review, deviation management, document control, and quality system support. The ideal candidate will have experience in Quality Assurance within a regulated industry and enjoy working with quality systems, documentation, investigations, and cross-functional teams to maintain the highest standards of compliance and product quality.
Key Responsibilities
- Review batch records to ensure accuracy, completeness, and compliance with GMP, FDA, and ISO requirements.
- Inspect and approve incoming raw materials to verify quality standards and documentation requirements are met.
- Manage deviations, investigations, CAPAs, and change controls, ensuring timely resolution and effective corrective actions.
- Perform shipping release activities and verify products meet all quality requirements prior to release.
- Support the preparation and maintenance of Annual Product Review documentation.
- Maintain quality records and support document control activities, including document change requests (DCRs).
- Compile, organize, and analyze quality data to support reporting, trending, and continuous improvement initiatives.
- Coordinate quality-related training activities and maintain training records.
- Utilize electronic quality management systems (eQMS) for document control, change management, and quality record administration.
- Collaborate with production and cross-functional teams to resolve quality concerns and improve compliance.
- Support internal, customer, and regulatory audits by ensuring documentation is accurate, complete, and readily available.
- Contribute to the continuous improvement of quality systems, procedures, and documentation practices.
Qualifications
- Bachelor's degree in Biology, Chemistry, Microbiology, Pharmaceutical Sciences, or another scientific discipline.
- 2+ years of experience in a regulated GMP, FDA, or ISO environment for Quality Assurance Specialist-level candidates.
- Experience working in Quality Assurance within the pharmaceutical, biotechnology, medical device, or other highly regulated industries.
- Strong knowledge of GMP, FDA, and ISO requirements.
- Experience performing batch record review and quality documentation review.
- Experience managing deviations, investigations, CAPAs, and change controls.
- Familiarity with document control processes and document change requests (DCRs).
- Experience supporting audits and inspections in a regulated environment.
- Proficiency with electronic quality management systems (eQMS).
- Strong attention to detail and organizational skills.
- Excellent written and verbal communication abilities.
- Ability to manage multiple priorities while maintaining compliance and documentation accuracy.
Work Environment
This is an on-site, office-based Quality Assurance role operating on a Monday through Friday, first-shift schedule. The position is primarily located within the Quality Assurance office area and involves regular interaction with electronic quality management systems and quality documentation.
The role provides a stable weekday schedule while offering opportunities to collaborate closely with production, operations, and other departments to support compliance and quality initiatives. The environment emphasizes organization, accuracy, teamwork, and adherence to regulatory standards.
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 - $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
Job Type & Location
This is a Permanent position based out of Waunakee, WI.
Application Deadline
This position is anticipated to close on Oct 29, 2026.
Workplace Type
This is a fully onsite position in Waunakee,WI.
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 actalentaccommodation@actalentservices.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.