Quality Auditor III

Job Title: Quality Auditor - III

Location: Andover, MA

Type: Contract

Compensation: $59.50

Contractor Work Model: Remote – offsite

Hours: 40.0

Overview
Leading pharmaceutical company looking for an experienced Quality Auditor III. This role is mostly remote with some travel to the Indiana CMO site. Ideal candidates should have 7 years of Quality Assurance / Quality Management experience.

Responsibilities

• Manage day-to-day quality oversight of the CMO manufacturing operations, building and maintaining strong relationships with the CMO’s quality and operations teams.
• Travel to the Indiana manufacturing site as needed, especially during onboarding and initial phases.
• Conduct oversight related to aseptic processes and ensure compliance with internal and external standards.
• Participate in virtual site operating team meetings and cross-functional project discussions.
• Review batch records, validation protocols, engineering run protocols, and other GMP documentation.
• Support investigations, deviation management, and root cause analyses.
• Prepare and manage change controls as needed.
• Ensure operations meet cGMP requirements and quality expectations.
• Collaborate with internal GCMC and Regulatory Affairs partners to understand regulatory considerations impacting product manufacturing at the CMO.

Requirements

• Quality Assurance / Quality Management experience (ideally 7 years).
• Regulatory experience sufficient to interface effectively with regulatory and GCMC teams.
• Aseptic manufacturing experience (highest priority due to product risk profile).
• Experience managing or overseeing CMO relationships (preferred).
• Strong understanding of aseptic operations in a GMP environment.
• Experience with aseptic medical device manufacturing is ideal.
• Ability to navigate complex cross-functional environments and virtual team structures.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.