Quality Systems Analyst

Job Title: Quality Systems Analyst
Location: Boston, MA
Contractor Work Model: Onsite
Hours: M-F 8am-4:30pm
Compensation: $70.00 - $125.00/hr
Type: Contract, Potential for extension or conversion to permanent

Overview

We are seeking an experienced Quality Systems Engineer contractor to support our GMP biotechnology operations. In this role, you will serve as a hands-on quality partner to Subject Matter Experts (SMEs) across manufacturing, laboratory, and technical functions. Your primary focus will be facilitating the timely and compliant completion of quality records — including change controls, deviations, laboratory investigations, and controlled document revisions — within our electronic Quality Management System (eQMS).

The ideal candidate brings strong working knowledge of GMP regulations, excellent writing and communication skills, and the ability to guide non-quality personnel through complex quality processes efficiently and without unnecessary burden.

Responsibilities

• Partner with SMEs to author, document, and route change control records in the eQMS
• Assist operations and technical teams in opening, writing, and closing deviation records
• Ensure change descriptions, impact assessments, and implementation plans are thorough, accurate, and compliant with GMP requirements
• Track change control and deviation timelines and proactively follow up to prevent aging records
• Collaborate with QC and analytical teams to support the documentation of Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations
• Support SMEs in managing documents through the review, approval, and release workflow in the eQMS (e.g., Veeva Vault)
• Serve as a resource and coach for SMEs navigating quality processes and eQMS workflows
• Identify and escalate quality issues or systemic trends to Quality management
• Support audit readiness by ensuring quality records are complete, accurate, and on-time
• Contribute to continuous improvement initiatives within the Quality Systems function
  

• Strong understanding of GMP regulations and quality documentation processes
• Experience with eQMS systems such as Veeva Vault preferred
• Excellent attention to detail and organizational skills
• Effective communication and collaboration abilities
• Ability to support audit preparations and manage documentation workflows

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.

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