Quality System Engineer

Job Title: Quality Systems Analyst

Location: Boston MA

Duration: 16 Months

Position Summary

We are seeking an experienced

Quality Systems Engineer (Contractor)

to support GMP biotechnology operations. This role will act as a hands-on quality partner to Subject Matter Experts (SMEs) across manufacturing, laboratory, and technical teams.

The primary focus of this position is to ensure the timely, accurate, and compliant completion of quality records—including change controls, deviations, laboratory investigations, and controlled document updates—within the electronic Quality Management System (eQMS).

Key Responsibilities

• Partner with SMEs to author, review, and route

change control records

within the eQMS

• Support operations and technical teams in initiating, writing, and closing

deviation records

• Ensure change descriptions, impact assessments, and implementation plans meet

GMP compliance standards

• Track and manage timelines for change controls and deviations; proactively follow up to prevent aging records

• Collaborate with QC and analytical teams to document

Out-of-Specification (OOS)

and

Out-of-Trend (OOT)

investigations

• Support document lifecycle activities, including review, approval, and release in eQMS platforms (e.g., Veeva Vault)

• Serve as a resource and coach to SMEs on quality processes and eQMS workflows

• Identify and escalate quality issues or systemic trends to Quality Management

• Support audit readiness by ensuring all quality records are complete, accurate, and inspection-ready

• Contribute to continuous improvement initiatives within the Quality Systems function

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related field

• Proven experience in

GMP-regulated biotechnology or pharmaceutical environments

• Strong hands-on experience with

eQMS systems

(e.g., Veeva Vault, TrackWise, MasterControl)

• Solid understanding of

deviations, CAPA, change control, OOS/OOT investigations

, and document control processes

• Excellent technical writing, documentation, and communication skills

• Ability to collaborate cross-functionally and guide non-quality stakeholders through quality processes

• Strong attention to detail with the ability to manage multiple priorities and timelines

Preferred Qualifications

• Prior experience supporting

biotech manufacturing or laboratory operations

• Experience driving

process improvements

within Quality Systems

• Familiarity with regulatory expectations (FDA, EMA, ICH guidelines)