Quality Systems Specialist - CAPAs And Deviations

Job Title:

Quality Systems Specialist - CAPAs and Deviations Job Description The Quality Systems Specialist plays a crucial role in supporting cGMP quality system activities within a biopharmaceutical manufacturing environment. The position involves executing and maintaining quality processes such as GMP training programs, validation and qualification document review, investigations, deviations, change controls, and CAPAs. A significant portion of the role focuses on overseeing the CAPA system, tracking progress, ensuring timely closure of CAPAs, managing extensions, and assisting with deviations. The specialist collaborates cross-functionally to ensure adherence to quality system procedures, supports continuous improvement initiatives, coordinates internal and external audits, manages training documentation, and oversees activities like APR preparation and change control governance to ensure regulatory compliance and product quality. Responsibilities Oversee the CAPA system, ensuring CAPAs are tracked and closed out timely. Assist with managing deviations and implementing necessary changes. Execute and maintain GMP training programs and quality processes. Review validation and qualification documents. Collaborate cross-functionally to ensure compliance with quality system procedures. Support continuous improvement initiatives. Coordinate internal and external audits. Manage training documentation. Oversee activities such as APR preparation and change control governance. Essential Skills Quality assurance expertise. Experience in quality auditing and document control. Familiarity with compliance and FDA regulations. Proficiency in managing quality management systems and internal audits. Experience with batch record reviews. Additional Skills & Qualifications Bachelor's degree or above in a scientific discipline. Minimum 2 years of Quality Assurance or Quality Systems experience in the biopharma/pharmaceutical industry. At least 2 years of experience working with CAPAs and deviations. Work Environment The role is based in a dynamic team environment with QMS Specialists and Document Control Technicians. The team is expanding with plans to add 2 more members. The work schedule is the first shift, Monday to Friday, with start times between 7-9 am for an 8-hour workday. The team works closely together, although space is currently limited. The office is located in building 1. Job Type & Location This is a Permanent position based out of Waunakee, WI. Pay and Benefits The pay range for this position is $52000.00 - $80000.00/yr. 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 Workplace Type This is a fully onsite position in Waunakee,WI. Application Deadline This position is anticipated to close on Apr 29, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.