Job Title: Quality Assurance Specialist: 3rd Shift Job Description The Quality Assurance Specialist will spend the majority of their time on the production floor, assisting the operations team with verifications, conducting general walkthroughs, performing onsite reviews, and executing mini-audits to ensure compliance. They will also be responsible for identifying solutions to problems, such as initiating deviations. Document review, including executed batch records, cleaning records, and logbooks, as well as issuing batch records when necessary, is also part of this role. Approximately 80-85% of the time will be spent on the floor, with the remainder in the office. Gowning requirements vary from safety shoes to full protective gear, depending on the area. Responsibilities + Assist the operations team with verifications and general walkthroughs. + Perform onsite reviews and mini-audits to ensure compliance. + Identify solutions to problems, such as initiating deviations. + Review documents, including executed batch records, cleaning records, and logbooks. + Issue batch records as needed. Essential Skills + Quality assurance expertise. + Experience with FDA regulations. + Batch record and CAPA (Corrective and Preventive Action) management. + Audit and document control skills. + Pharmaceutical industry knowledge. Additional Skills & Qualifications + Bachelor's degree in any science discipline preferred. + 2+ years of experience in a regulated industry (GMP/FDA/ISO) for specialists. + 5+ years of experience in a regulated industry for Sr. positions. + 7+ years of experience in a regulated industry for lead positions. + Experience supervising direct reports or leading teams is a plus. Work Environment The role involves working primarily on the production floor, with some time spent in an office environment. Employees work on nights (4pm to 4am) with a rotating schedule of 3 days on, 2 days off, 2 days on, and 3 days off. Training is conducted on the first shift, Monday to Friday, from 8 am to 4:30 pm for 6-8 weeks. Employees must adhere to varying gowning requirements, from safety shoes to full protective gear, depending on the area. Pay and Benefits The pay range for this position is $62000.00 - $90000.00/yr. Medical, dental, 401K, vision Workplace Type This is a fully onsite position in Madison,WI. Application Deadline This position is anticipated to close on Aug 27, 2025. 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.