LS Solutions is hiring: Senior Technical Writer in Cambridge

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Senior Talent Acquisition Specialist | Building High-Impact Teams | Tech & Non-Tech Hiring | Passionate about People & Possibilities

Location: Cambridge, MA

Duration: 12 months contract

JOB DESCRIPTION:

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 theQC 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

· Cell Counting (NC202)

· Flow Cytometry

Thanks,

Raja

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Analyst, Design, and Engineering

• Industries

  Pharmaceutical Manufacturing and Retail Pharmacies

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Medical insurance

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