Technical Writer

North Jersey, NJ – Onsite / Hybrid – 6-12 Months

About the role

We are seeking a Technical Writer with a 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.

Requirements

• 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.