Quality Assurance Specialist

Job Description

Job Description

Job Title: Quality Assurance Specialist

Job Description

The Quality Assurance Specialist ensures that all quality systems, documentation, and processes comply with applicable GMP, FDA, and ISO regulations. This role focuses on reviewing batch records, inspecting and approving raw materials, managing deviations and change controls, and supporting continuous improvement through investigations and CAPAs. The specialist also performs shipping release procedures and provides comprehensive administrative support to the QA department, including document control, data compilation, and coordination of training activities.

Responsibilities

• Review batch records thoroughly to verify accuracy, completeness, and compliance with GMP, FDA, and ISO requirements.
• Inspect and approve incoming raw materials to ensure they meet established quality specifications and documentation standards.
• Write and manage deviations, investigations, change controls, and CAPAs to address nonconformances and drive corrective and preventive actions.
• Perform shipping release procedures, ensuring that products meet all quality and documentation requirements prior to release.
• Support the preparation of Annual Product Review documentation for all marketed products, compiling data and ensuring timely completion.
• Provide administrative support to the QA department, including generating document change requests (DCRs), organizing files, and maintaining orderly records.
• Compile and analyze quality-related data to support reporting, trending, and continuous improvement initiatives.
• Coordinate QA-related training activities, including scheduling, tracking completion, and maintaining training records.
• Interact regularly with the electronic quality management system (EQMS) for document control, change management, and quality records.
• Collaborate with cross-functional teams, production areas, and other stakeholders to resolve quality issues and support compliance.
• Support internal and external audits by ensuring documentation is complete, organized, and readily accessible.
• Follow established quality procedures and contribute to the refinement of QA processes and documentation practices.

Essential Skills

• 2+ years of regulated industry experience in a GMP, FDA, or ISO environment for Specialist-level roles.
• 5+ years of regulated industry experience in a GMP, FDA, or ISO environment for Sr-level roles.
• Experience in quality assurance within a pharmaceutical or similarly regulated industry.
• Strong knowledge of GMP, FDA, and ISO quality system requirements and practices.
• Hands-on experience with batch record review and batch record documentation.
• Ability to write and manage CAPAs, deviations, investigations, and change controls.
• Experience with document control processes, including generating and processing document change requests (DCRs).
• Familiarity with audit processes and quality inspections in a regulated environment.
• Proficiency in using electronic quality management systems (EQMS) for document and quality record management.
• Strong attention to detail and accuracy in reviewing and maintaining quality documentation.
• Effective written and verbal communication skills for drafting quality documents and collaborating with cross-functional teams.
• Organizational skills for managing files, compiling data, and coordinating training activities.

Additional Skills & Qualifications

• Bachelor’s degree in a science discipline preferred for Specialist and Sr roles.
• Experience in pharmaceutical manufacturing or related life sciences industries.
• Familiarity with Annual Product Review processes and requirements.
• Ability to work independently in an office-based QA environment while collaborating with production and other departments.
• Comfort with handling multiple priorities and deadlines in a regulated setting.
• Strong problem-solving mindset with a focus on continuous improvement of quality systems.

Work Environment

This is an on-site, office-based Quality Assurance role, located in an office area outside of production. The position operates Monday through Friday on first-shift hours, providing a stable weekday schedule. The specialist works primarily in an office or QA area, which may be shared or independent, with regular interaction with an electronic quality management system (EQMS) for document control and quality records. The environment emphasizes compliance, organization, and collaboration with production and other departments, while maintaining a professional office setting.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $62000.00 - $90000.00/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 Aug 11, 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 actalentaccommodation@actalentservices.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.