Quality Systems Specialist - Auditing And Vendor Management

Job Title: Quality Systems Specialist - Auditing and Vendor Management

Job Description

The Quality Systems QA Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment, executing and maintaining processes managed through the MasterControl electronic Quality Management System (eQMS). This role involves building and managing a supplier and vendor quality program, including qualification and auditing of suppliers, with occasional domestic and international travel required. The specialist is responsible for GMP training programs, validation and qualification document review, deviations, investigations, CAPAs, and change controls. Collaboration cross-functionally to ensure compliance with internal procedures and global regulatory requirements is essential.

Responsibilities

• Build and manage a supplier and vendor quality program, including qualification and auditing of suppliers.
• Execute and maintain processes managed through the MasterControl eQMS.
• Conduct GMP training programs, validation and qualification document reviews.
• Handle deviations, investigations, CAPAs, and change controls.
• Collaborate cross-functionally to ensure compliance with internal procedures and global regulatory requirements.
• Support continuous improvement initiatives.
• Coordinate internal and external audits.
• Manage training documentation and oversee change control governance.
• Support Annual Product Review (APR) preparation.

Essential Skills

• Quality assurance
• Quality auditing
• Audit
• CAPA
• Compliance
• FDA knowledge
• Document control
• Quality system management
• Batch record handling
• Vendor management
• Internal audit
• Batch record review

Additional Skills & Qualifications

• Bachelor's degree or above in a Scientific discipline
• 1+ years of quality experience in the biopharma/pharmaceutical industry preferred
• Experience in managing vendors and auditing
• Willingness to occasionally travel (less than once a month)
• Open to candidates from food & beverage or Med Device backgrounds

Work Environment

The position operates on a 1st shift schedule from Monday to Friday, starting between 7-9am for 8-hour workdays. The team is based in Building 1, which is currently experiencing space constraints. The team consists of 4 QMS Specialists and 2 Document Control Technicians, with plans to add 2 more members.

Job Type & Location

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