Technical Writer

Title: Technical Writer

Location: North Jersey, NJ

Location Type: Onsite / Hybrid

Duration: 6-12 Months

Job Description

We are seeking a Technical Writer with strong understanding of pharmaceutical, biologics, and cell therapy manufacturing operations, along with Quality Control and Quality Assurance documentation. The resource will support authoring, revising, formatting, and routing GMP documents, technical procedures, reports, protocols, investigation write-ups, and quality system documentation.

This role requires someone who can understand technical content from Manufacturing, QC, QA, Validation, MSAT, Engineering, and Operations teams and convert it into clear, accurate, inspection-ready GMP documentation.

Responsibilities

• Author, revise, and maintain GMP technical documents, including SOPs, work instructions, batch-related procedures, protocols, reports, forms, templates, and controlled documents.
• Work closely with Manufacturing, QC, QA, Validation, MSAT, Engineering, and Operations teams to gather technical input and convert it into clear, compliant documentation.
• Support documentation related to biologics and cell therapy manufacturing processes, including aseptic operations, cleanroom practices, cell processing, upstream/downstream activities, and controlled GMP workflows.
• Draft and revise Quality Control documentation, including laboratory procedures, sample handling workflows, analytical/microbiology testing support documents, data review procedures, and QC investigation documentation.
• Support Quality Assurance documentation, including deviations, CAPAs, change controls, risk assessments, batch record review support, quality event summaries, and inspection-readiness documents.
• Review existing procedures and technical documents for accuracy, clarity, consistency, formatting, GDP compliance, and alignment with current site practices.
• Interview SMEs and process owners to understand actual shop-floor, laboratory, and quality system practices before drafting or revising documents.
• Assist in writing investigation summaries, root cause narratives, impact assessments, corrective/preventive action descriptions, and supporting technical justifications.
• Ensure documentation follows cGMP, GDP, data integrity, ALCOA , regulatory expectations, and internal document control standards.
• Support document lifecycle activities, including document creation, redline updates, review coordination, approval routing, version control, and archival readiness.
• Prepare technical summaries, process descriptions, training materials, flow diagrams, and user-friendly documents to support manufacturing, QC, and QA teams.
• Identify documentation gaps, inconsistencies, outdated language, or procedure-practice mismatches and work with SMEs to correct them.
• Support audit and inspection readiness by ensuring documents are accurate, complete, traceable, and aligned with current GMP expectations.
• Manage multiple documentation assignments and timelines while coordinating feedback from cross-functional reviewers and approvers.
  
  

Qualifications

• Bachelor s degree in Life Sciences, Biology, Biotechnology, Chemistry, Pharmaceutical Sciences, Engineering, or related field preferred.
• 3 years of technical writing, GMP documentation, quality documentation, manufacturing documentation, or regulated documentation experience.
• Experience supporting pharmaceutical, biotechnology, biologics, cell therapy, or other GMP-regulated manufacturing environments.
• Strong understanding of GMP documentation, Good Documentation Practices, SOP structure, controlled document workflows, and quality system expectations.
• Working knowledge of Manufacturing, QC, and QA terminology within regulated life sciences environments.
• Ability to work with technical SMEs and translate complex process or quality information into clear, accurate written documents.
• Experience with deviations, CAPAs, change controls, investigations, batch records, QC procedures, validation documents, or audit-readiness documentation preferred.
• Strong attention to detail, grammar, formatting, consistency, and document traceability.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, SharePoint, and document management systems.
• Experience with Veeva, MasterControl, TrackWise, ValGenesis, Kneat, SAP, LIMS, or similar GMP systems is preferred.
  
  

Preferred Skills

• Prior experience supporting biologics or cell therapy manufacturing documentation.
• Familiarity with aseptic processing, cleanroom operations, cell culture, cell processing, QC laboratory testing, and QA quality systems.
• Experience writing or revising SOPs, batch record-related documents, investigation reports, validation protocols/reports, and quality event documentation.
• Ability to support high-volume documentation remediation, procedure updates, audit responses, and inspection readiness activities.