Quality Assurance Specialist

Quality Assurance SpecialistJoin 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.ResponsibilitiesReview 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.Qualifications2+ 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 EnvironmentThis 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.Job Type & LocationThis is a Permanent position based out of Waunakee, WI.Pay and BenefitsThe 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; 401kWorkplace TypeThis is a fully onsite position in Waunakee,WI.Application DeadlineThis position is anticipated to close on Sep 7, 2026.