Quality Systems Analyst

Job Title: Quality Systems Analyst
Location: Boston, MA
Contractor Work Model: Onsite
Hours: M-F 8am-5pm
Compensation: $70.00 - $125.00/hr
Type: Contract, Potential for extension or conversion to permanent

Overview
We are seeking an experienced Quality Systems Analyst 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). This role will assist with the continued quality oversight of GMP production and testing of clinical trial materials at contract development and manufacturing organizations (CDMOs) and contract testing labs (CTLs). In addition, responsible for review of Regulatory submissions and source data verification. The individual will be a collaborative, quality professional with biotech GMP compliance experience, with exceptional communication skills to support a pipeline of gene editing products. This role will be responsible for document review as well as assisting with the maintenance of phase-appropriate quality systems, including GxP compliance, document control, validation, and quality control.

Responsibilities

• Assist in Quality oversight for external GMP production and testing activities for clinical stage products and materials
• Review master batch records, executed batch records, analytical testing protocols, methods, reports, testing records, stability documentation, and other quality documentation as needed
• Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
• Perform review of Regulatory submissions and source data verification
• Manage review and approval of analytical testing protocols, methods, and qualification/validation reports
• Support review of regulatory filing activities as needed
• Assist in establishing and maintaining internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations
• 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
• Other duties as assigned

• Advanced skills in MS Office including SharePoint
• Experience working with eQMS software
• Strong working knowledge of GMP regulations
• Strong pharmaceutical and/or biotechnology knowledge
• Strong data analysis skills
• Excellent writing and communication skills
• Ability to guide non-quality personnel through complex quality processes efficiently and without unnecessary burden

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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Ref: #558-Scientific