<p>Job Title: Quality Assurance Specialist</p> <p>Job Description</p> <p>The Quality Assurance Specialist is responsible for ensuring proper documentation, reviewing batch records, inspecting and approving raw materials, writing deviations, conducting investigations, managing change controls, and implementing CAPAs. This individual will perform shipping release procedures and support the preparation of Annual Product Review documentation for all marketed products. This individual will provide administrative support to the QA department including generating DCRs, organizing files, compiling data, and coordinating training activities.</p> <p>Responsibilities</p> <ul> <li>Ensure proper documentation and review batch records. </li><li>Inspect and approve raw materials. </li><li>Write deviations, conduct investigations, and manage change controls. </li><li>Implement Corrective and Preventive Actions (CAPAs). </li><li>Perform shipping release procedures. </li><li>Support preparation of Annual Product Review documentation. </li><li>Provide administrative support to the QA department. </li><li>Generate DCRs, organize files, and compile data. </li><li>Coordinate training activities. </li></ul> <p>Essential Skills</p> <ul> <li>Quality assurance expertise. </li><li>Experience with FDA regulations and GMP/ISO standards. </li><li>Proficiency in batch record review and document control. </li><li>Understanding of CAPA processes. </li><li>Ability to conduct audits. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Bachelor's degree in any science discipline preferred. </li><li>2+ years of experience in a regulated industry (GMP/FDA/ISO) required. </li><li>May consider candidates with 10 years of experience and an Associate's degree. </li></ul> <p>Work Environment</p> <p>This is an office-based role with interaction with the EQMS system. The position operates outside of production areas, offering either shared or independent office space. Work is conducted during regular Monday to Friday, first shift hours.</p> <p>Job Type & Location</p> <p>This is a Permanent position based out of Waunakee, WI.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $62000.00 - $90000.00/yr.</p> <p>Medical, Dental, Vision, 401K</p> <p>Workplace Type</p> <p>This is a fully onsite position in Waunakee,WI.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Dec 26, 2025.</p> <p>About Actalent</p> <p>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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.</p> <p>The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.</p> <p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.</p>