QC Tech Writer Job at LS Solutions in Cambridge

Overview

Our client is a cell and gene therapy company; a new research and development (R&D) unit focused on advancing cell therapies in oncology and immunology. They are seeking an experienced QC Tech Writer to support their QMS documents, deviations / investigations, and jump in on testing when needed.

Roles and Responsibilities

• Own and manage Quality documentation within Veeva QMS, including change controls, CAPAs, deviations, and investigations.
• Lead or support deviation investigations, root cause analysis, and corrective/preventive action development.
• Collaborate with cross-functional teams (QC, QA, Manufacturing, MS&T) to ensure timely closure of quality events.
• Support audit readiness and regulatory compliance efforts within the QC organization.
• Assist with QC Analytical Lab testing on an as-needed basis, including sample handling, test execution, and data documentation aligned with GMP standards.
• Participate in continuous improvement initiatives related to Quality and Laboratory operations.

Required Skillset

• 5-7+ years of experience in the industry. Direct experience and background with the QC lab.
• Experience with Deviations and Investigations from start to finish.
• Experience with PCR or ddPCR required.
• Would be beneficial to have experience with analytical instruments and have worked in a cell and gene therapy company.
• Strong technical writing and communication skills.
• DNA extractions
• Cell Counting (NC202)
• Flow Cytometry

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Marketing, Public Relations, and Writing/Editing

Industries

• Business Consulting and Services