Job Information
Actalent Quality Systems Specialist - CAPAs And Deviations in Waunakee, Wisconsin
Job Title: Quality Systems Specialist - CAPAs and DeviationsJob Description
The Quality Systems QA Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment. The role involves executing and maintaining quality processes such as GMP training programs, validation and qualification document review, investigations, deviations, change controls, and CAPAs. A primary focus will be overseeing the CAPA system, ensuring CAPAs are tracked, closed out, and managing any necessary extensions while assisting with deviations.
Responsibilities
Oversee and manage the CAPA system to ensure timely closure and compliance.
Track and manage deviations, ensuring appropriate resolutions.
Collaborate cross-functionally to ensure adherence to quality system procedures.
Support continuous improvement initiatives and participate in internal and external audits.
Manage training documentation and oversee activities like APR preparation and change control governance.
Ensure regulatory compliance and maintain product quality.
Essential Skills
Quality assurance
Quality auditing
Audit compliance
CAPA management
Familiarity with FDA regulations
Document control
Quality management systems
Internal audit expertise
Batch record review
Additional Skills & Qualifications
Bachelor’s degree or above in a Scientific discipline
2+ years of Quality Assurance or Quality Systems experience in the biopharma/pharmaceutical industry
2+ years of experience working with CAPAs and deviations
Work Environment
The team is situated in Building 1 and is expanding, consisting of 4 QMS Specialists and 2 Document Control Technicians, with plans to add 2 more members. The role operates on the 1st shift, Monday to Friday, with a flexible start time between 7-9am, working 8-hour days.
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 30, 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.