Quality Systems Specialist

About the role

The Quality Systems Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment, executing and maintaining processes managed through the MasterControl electronic Quality Management System (eQMS).

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.
• Cook up internal and external audits.
• Manage training documentation and oversee change control governance.
• Support Annual Product Review (APR) preparation.

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)

Additional Skills

• Work Environment
• This is a Permanent position based out of Madison, WI.
• 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.
• Job Type & Location
• This is a fully onsite position in Madison,WI.

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.

Equal Opportunity Employer

We are 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.

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.