Senior Technical Writer – Quality Documentation & Change Control
Location: 100% Onsite- Branchburg, NJ
Industry: Pharmaceutical / Medical Device / Biotechnology
Contract through the end of 2026 with potential extensions
Up to $28/hr based on benefit elections
About the Role
Orion Group is seeking an experienced Senior Technical Writer – Quality Documentation & Change Control to support the development, creation, revision, and management of controlled documentation within a highly regulated pharmaceutical manufacturing environment.
This role will author and revise SOPs, work instructions, batch records, forms, and other controlled documents while partnering closely with Manufacturing, Engineering, Process Development, Quality, CAPA/Investigations, Change Control, and other subject matter experts.
The ideal candidate has hands-on technical writing experience within pharmaceutical, biotechnology, or medical device environments and understands how to translate complex technical processes into clear, accurate, compliant documentation.
Key Responsibilities
- Author, revise, edit, and maintain controlled documentation, including:
- Standard Operating Procedures (SOPs)
- Work Instructions
- Batch Records
- Forms and other GMP-controlled documentation
- Serve as an Initiator for Change Controls and manage activities through completion while working against tight deadlines.
- Gather technical information from subject matter experts and translate complex processes into clear, straightforward procedures.
- Ensure documents contain the appropriate level of detail and accurately reflect process and product specifications.
- Serve as an SME for document creation, formatting, revision, and Electronic Document Management System (EDMS) processes.
- Process controlled documentation within the EDMS in accordance with established policies and procedures.
- Review and evaluate change requests of varying complexity and support activities required for timely closure.
- Partner with Manufacturing, Engineering, Process Development, Quality, CAPA/Investigations, Change Control, and other cross-functional teams to develop and revise document content.
- Proofread and edit technical documentation for accuracy, consistency, grammar, formatting, and compliance.
- Support continuous improvement initiatives related to document management and documentation processes.
- Develop and deliver training and guidance to change initiators and support staff.
- Represent Quality Documentation and Change Control during regulatory audits.
- Communicate project status, risks, and documentation issues to management and escalate concerns when appropriate.
- Provide team leadership and guidance as needed and support Change Control leadership in their absence.
Qualifications
- Bachelor's degree or 5–7 years of equivalent relevant professional experience.
- 3–5 years of technical writing experience within a pharmaceutical, medical device, biotechnology, or similarly regulated environment.
- Demonstrated experience authoring and revising SOPs, work instructions, batch records, forms, and controlled documentation.
- Working knowledge of GMP/GxP requirements and regulated Quality Systems.
- Basic knowledge of applicable regulations and standards, including 21 CFR Part 820, ISO 13485, FDA requirements, and AATB standards.
- Strong experience working within an Electronic Document Management System (EDMS); One Vault experience is highly preferred.
- Experience with SAP or another ERP system preferred.
- Advanced Microsoft Word skills, including tables, headers/footers, formatting, document review, and revision capabilities.
- Strong proofreading, editing, grammar, and technical writing skills.
- Ability to gather information from technical SMEs and convert complex processes into clear, usable documentation.
- Strong organizational and project management capabilities with the ability to manage multiple priorities and tight deadlines.
- Excellent written, verbal, and interpersonal communication skills.
- Ability to work effectively with cross-functional stakeholders at varying levels of the organization.
- Experience providing training or guidance related to controlled documentation and change control processes is preferred.
What We're Looking For
The strongest candidate will bring a combination of technical writing expertise and Quality Systems knowledge. This is not simply a general writing position — we're looking for someone who understands controlled documentation within a regulated environment and can confidently work with technical SMEs to ensure documentation is accurate, detailed, compliant, and completed on schedule.
Key Skills:
Technical Writing SOP Authoring Controlled Documentation Change Control EDMS GMP/GxP 21 CFR 820 ISO 13485 Batch Records Work Instructions Quality Systems Microsoft Word SAP Document Control Pharmaceutical / Medical Device / Biotech
Pay: $23.00 - $28.00 per hour
Benefits:
- 401(k) 2% match
- Dental insurance
- Health insurance
- Vision insurance
Education:
Experience:
- Technical writing: 3 years (Preferred)
- Pharmaceutical Industry : 3 years (Preferred)
- SAP: 1 year (Preferred)
- Quality systems: 3 years (Preferred)
Work Location: In person
