Quality Assurance Specialist

Quality Assurance Specialist + 12-hour rotating shifts + Nights: 3 days on / 2 days off / 2 days on / 3 days off (4:00 PM u2013 4:00 AM) + Training Schedule: Mondayu2013Friday, 8:00 AM u2013 4:30 PM for 6u20138 weeks Job Description The Quality Assurance Specialist will spend the majority of their time on the production floor assisting the operations team. They will perform verifications, conduct general walk-throughs, and carry out onsite reviews and mini audits to ensure compliance with established procedures. The role involves problem-solving, such as initiating deviations, and includes reviewing documents like executed batch records, cleaning records, and log books. When necessary, they will issue batch records. Approximately 80-85% of the time will be spent on the production floor, with the remainder in the office. Gowning requirements vary by area, ranging from safety shoes to full gowning. Responsibilities + Assist the operations team with verifications and conduct general walk-throughs of the production area. + Perform onsite reviews and mini audits to ensure compliance with established procedures. + Initiate deviations and propose solutions to identified problems. + Review documents including executed batch records, cleaning records, and log books. + Issue batch records as required. Essential Skills + Quality assurance expertise. + Experience with FDA regulations. + Knowledge of batch records and CAPA processes. + Experience in conducting audits and document control. + Familiarity with pharmaceutical industry standards. Additional Skills & Qualifications + Bachelor's degree in any science discipline preferred. + 2+ years of experience in a regulated industry (GMP/FDA/ISO) for Specialist level. + 5+ years of experience in a regulated industry (GMP/FDA/ISO) for Sr level. + 7+ years of experience in a regulated industry (GMP/FDA/ISO) for Lead level, with potential to supervise or lead. + Associates with 10 years of experience may be considered. Work Environment The work environment predominantly involves being on the production floor, with some time in an office setting. Interaction with the EQMS system is required. Employees are eligible for schedule incentives and shift differentials based on their assigned shifts. 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. 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, 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. Application Deadline This position is anticipated to close on Feb 23, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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. 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 ( ) for other accommodation options.

Created: 2026-02-11