Quality Assurance Specialist

Job Description

Job Description

Job Title: Quality Assurance Specialist
Job Description

The Quality Systems Quality Assurance Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment. This role focuses on executing and maintaining key quality processes, including GMP training programs, validation and qualification document review, investigations, deviations, change controls, and corrective and preventive actions (CAPAs). The specialist spends a majority of the day overseeing the CAPA system, tracking progress, driving timely closure, managing extensions when needed, and supporting deviation management. The position collaborates cross‑functionally to ensure compliance with quality system procedures, supports continuous improvement initiatives, participates in internal and external audits, manages training documentation, and oversees activities such as annual product review (APR) preparation and change control governance to ensure regulatory compliance and product quality.

Responsibilities

• Execute and maintain cGMP quality system processes within a biopharmaceutical manufacturing environment.
• Oversee the CAPA system, including tracking CAPAs, driving closure, and managing extensions as needed.
• Support deviation management by providing information, assisting with write‑ups, and contributing to root cause analyses.
• Review validation and qualification documentation to ensure compliance with internal procedures and regulatory expectations.
• Support and maintain GMP training programs, including managing training documentation and ensuring accurate recordkeeping.
• Participate in and support internal and external audits by providing documentation, responding to observations, and helping implement corrective actions.
• Contribute to investigations related to quality issues, deviations, and non‑conformances, ensuring thorough documentation and follow‑up.
• Support change control governance by reviewing and tracking changes to processes, systems, and documentation.
• Assist with the preparation and maintenance of annual product reviews (APR) and related quality reports.
• Collaborate cross‑functionally with manufacturing, quality control, 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 and operational efficiency.
• Perform document control and batch record review activities to ensure completeness, accuracy, and compliance with cGMP requirements.
• Maintain compliance with FDA and other applicable regulatory guidelines through consistent application of quality system processes.

• Quality assurance experience in a regulated environment, preferably within the biopharmaceutical or pharmaceutical industry.
• Quality systems experience, including practical exposure to cGMP requirements and quality management system processes.
• At least 4+ months of experience working with CAPAs and deviations, including providing information, assisting with write‑ups, and supporting root cause analysis activities.
• Understanding of compliance requirements related to FDA regulations and cGMP standards.
• Experience with document control and batch record review in a quality‑focused environment.
• Ability to support internal audits and external regulatory or customer audits.
• Strong attention to detail and accuracy in documentation and recordkeeping.
• Effective communication skills for cross‑functional collaboration and audit interactions.
• Ability to manage multiple quality system activities simultaneously and prioritize work in a fast‑paced environment.

• Bachelor’s degree or above in a scientific discipline.
• 4+ months of Quality Assurance or Quality Systems experience in the biopharma or pharmaceutical industry preferred; experience in food and beverage or medical device industries is also considered.
• Experience with quality system elements such as CAPA management, deviation handling, investigations, and change controls.
• Familiarity with quality auditing practices and internal audit processes.
• Knowledge of quality management systems and quality system documentation requirements.
• Ability to support continuous improvement efforts within quality systems.
• Comfort working with training documentation and GMP training program administration.

This position is based in a biopharmaceutical manufacturing environment within an office and quality systems setting. The role is part of a growing quality systems team that currently includes Quality Management System Specialists and Document Control Technicians, with plans to add additional team members. 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 closely together in a shared building, fostering collaboration and communication across quality and operational functions.

Job Type & Location

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

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

This is a fully onsite position in Waunakee,WI.

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 ziprecruiter.com 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.