Quality Assurance Specialist

Job Title: Quality Assurance Specialist - 3rd Shift

Job Description

The Quality Assurance Specialist works primarily on the production floor to support operations by performing real-time verifications, walk-throughs, and mini audits to ensure processes consistently meet Good Manufacturing Practice (GMP) and regulatory standards. This role combines hands-on floor presence with detailed documentation review, problem-solving, and deviation management, requiring strong initiative, independence, and comfort making decisions during limited-supervision night shifts.

Responsibilities

• Provide real-time GMP quality oversight on the production floor, spending the majority of time supporting operations.
• Perform production walkthroughs, reviews, and mini audits to ensure compliance with FDA, GMP, and ISO requirements.
• Identify and address deviations, nonconformances, and documentation issues; initiate deviations and support investigations and CAPAs.
• Review executed batch records, cleaning records, and logbooks for accuracy and compliance; issue and control batch records as needed.
• Deliver real-time guidance and GMP training to operators, reinforcing proper documentation and process controls.
• Document and communicate quality observations clearly and collaborate with QA and operations to drive continuous improvement.
• Work independently on 3rd shift with limited supervision while maintaining high quality and compliance standards.

Qualifications

• Experience in Quality Assurance within a GMP/FDA/ISO regulated environment:
  • Specialist: 2 years | Sr: 5 years | Lead: 7 years
• Strong knowledge of GMP principles and pharmaceutical or regulated manufacturing environments.
• Experience with batch record review, deviations, investigations, CAPA, and electronic quality systems (EQMS).
• Ability to work independently on overnight shifts and make sound quality decisions.
• Strong attention to detail, communication skills, and comfort working on the production floor.

Education

• Bachelor’s degree in a scientific discipline preferred; equivalent experience may be considered.

Work Environment

This role is primarily on-site within a production environment, with approximately 60–70% of time spent on the production floor and the remaining time in an office setting for documentation and reporting activities.

This is a 3rd shift role.

This is a Permanent position based out of Madison, WI.

The pay range for this position is $62000.00 - $90000.00/yr.

Eligible for 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, the company offers 160 hours of vacation & 40 hours of sick time (both pro-rated base on hire date) and 9 paid holidays.

This is a fully onsite position in Madison,WI.

This position is anticipated to close on May 20, 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.

Salary : $62,000 - $90,000