GMP Quality Specialist

Actalent; Madison (WI); On-site; USD 60,000 - 85,000; Full time

Job summary

Actalent in Madison, WI is seeking a GMP Quality Specialist to support quality systems, regulatory requirements, and continuous improvement in a manufacturing environment.

You will review documentation, participate in audits, validations, and CAPA activities, and drive quality metrics across departments with a focus on electronic system transitions. A strong QA background and attention to detail are essential.

Qualifications

• 5+ years of Quality Assurance experience in a GMP-regulated environment.
• Experience managing Deviations, CAPAs, Change Controls, Investigations, and Quality Systems.
• Working knowledge of FDA 21 CFR regulations, cGMP requirements, and ICH guidelines.
• Experience supporting validations and manufacturing quality processes.
• Proficiency with Microsoft Office, including Excel.

Responsibilities

• Review and approve SOPs, protocols, reports, and other quality documents.
• Support Investigations, Deviations, CAPA, Change Control, and Complaint programs.
• Participate in validation activities and quality system improvement projects.
• Assist with internal, supplier, and regulatory audits.
• Support regulatory compliance activities and responses to agency inquiries.
• Track quality metrics and ensure compliance across departments.
• Develop and maintain quality system documentation.
• Support the transition to electronic quality systems and process improvements.

Skills

Quality Assurance

Regulatory compliance

GMP

Audits

Documentation

Attention to detail

Independent work

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related field

Tools

Microsoft Office

Excel

Job description

GMP Quality Specialist

Join a Growing Quality Team

We are seeking an experienced QA Specialist to support quality systems, compliance activities, and regulatory requirements in a GMP-regulated manufacturing environment. This role will partner closely with multiple departments to ensure product quality, regulatory compliance, and continuous improvement initiatives.

Responsibilities

• Review and approve SOPs, protocols, reports, and other quality documents

• Support Investigations, Deviations, CAPA, Change Control, and Complaint programs

• Participate in validation activities and quality system improvement projects

• Assist with internal, supplier, and regulatory audits

• Support regulatory compliance activities and responses to agency inquiries

• Track quality metrics and ensure compliance across departments

• Develop and maintain quality system documentation

• Support the transition to electronic quality systems and process improvements

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or a related scientific field

• 5+ years of Quality Assurance experience in a pharmaceutical, biotechnology, dietary supplement, or GMP-regulated environment

• Experience managing Deviations, CAPAs, Change Controls, Investigations, and Quality Systems

• Working knowledge of FDA 21 CFR regulations, cGMP requirements, and ICH guidelines

• Experience supporting validations and manufacturing quality processes

• Strong attention to detail, organizational skills, and ability to work independently

• Proficiency with Microsoft Office, including Excel

Why Join Us?

• Collaborative, close-knit quality team

• Opportunity to support a wide variety of quality systems and compliance initiatives

• Exposure to validation, auditing, and regulatory activities

• Competitive benefits package and strong work-life balance

• Growing organization focused on automation and continuous improvement

Job Type & Location

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

Pay and Benefits

The pay range for this position is $28.85 - $40.87/hr.

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.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Madison,WI.

Application Deadline

This position is anticipated to close on Sep 18, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.