Quality Systems Specialist

Job Title: Quality Systems Specialist

Job Description

The Quality Systems Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment, with a primary focus on executing and maintaining quality processes such as GMP training programs, validation and qualification document review, investigations, deviations, change controls, and CAPAs. The role centers on overseeing the CAPA system, including tracking actions, driving timely closure, managing extensions, and supporting deviation management. This position collaborates cross-functionally to ensure compliance with quality system procedures, supports continuous improvement initiatives, contributes to internal and external audits, manages training documentation, and oversees activities such as annual product review preparation and change control governance to ensure regulatory compliance and product quality.

Responsibilities

• Oversee the CAPA system on a daily basis, including tracking CAPAs, driving timely closure, and managing extensions as needed.

• Support deviation management by gathering information, assisting with write-ups, and contributing to root cause analysis activities.

• Execute and maintain cGMP quality system processes, including GMP training programs, validation and qualification document review, investigations, deviations, change controls, and CAPAs.

• Review and control quality documentation to ensure accuracy, completeness, and compliance with established procedures.

• Collaborate cross-functionally with manufacturing, quality, and other departments to ensure adherence to quality system procedures and regulatory requirements.

• Support continuous improvement initiatives within the quality management system to enhance compliance, efficiency, and product quality.

• Participate in internal and external audits by providing documentation, answering questions, and demonstrating adherence to quality standards and regulatory expectations.

• Manage and maintain training documentation to ensure personnel training records are accurate, current, and compliant with cGMP requirements.

• Contribute to annual product review preparation and change control governance to support regulatory compliance and ongoing product quality.

• Perform quality assurance and quality auditing activities, including batch record review and internal audit support, in alignment with FDA and other regulatory guidelines.

Essential Skills

• Bachelor's degree or above in a scientific discipline.

• Approximately 4+ months of Quality Assurance or Quality Systems experience in the biopharmaceutical or pharmaceutical industry preferred; experience in food and beverage or medical device environments is also considered.

• Approximately 4+ months of experience working with CAPAs and deviations, including providing information, assisting with write-ups, and participating in root cause analysis.

• Knowledge of cGMP principles and quality management systems within a regulated manufacturing environment.

• Experience with CAPA processes, deviation handling, and change control activities.

• Understanding of FDA compliance expectations and regulatory requirements for quality systems.

• Ability to perform quality auditing and internal audit support activities.

• Proficiency in document control and maintaining accurate, compliant quality records.

• Strong attention to detail and ability to manage multiple quality system activities simultaneously.

• Effective communication and collaboration skills for cross-functional work in a quality-focused environment.

Work Environment

Work is performed on first shift, Monday through Friday, with a flexible start time between 7:00 a.m. and 9:00 a.m., and standard eight-hour workdays. The team works together in a shared office environment within the facility, with a focus on collaboration and close coordination among quality systems and document control staff.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $45000.00 - $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 Madison,WI.

Application Deadline

This position is anticipated to close on Jul 20, 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 View email address on click.appcast.io 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.