A validation and quality assurance provider is looking to hire a
Technical Writer (SOPs, Work Instructions, Training Records) for their
Rensselaer, NY project site. This is a six month to one year + Hybrid (onsite and remote) assignment
Hourly rate $40.00
Overview We are seeking a detail-oriented Technical Writer with hands-on experience creating SOPs, Work Instructions, and Training Records for a GMP-regulated pharmaceutical environment. The successful candidate will document and standardize processes within Adept by Synergis Software, ensuring content meets regulatory requirements, quality systems expectations, and user needs. This role supports the implementation, maintenance, and continuous improvement of electronic records, workflows, and training documentation to support compliant manufacturing operations.
Key Responsibilities
- Develop, revise, and maintain high-quality SOPs, Work Instructions, and training materials aligned with GMP guidelines and company quality policies.
- Create and organize Training Records, ensuring accurate tracking of qualification, competency, and duration of training for personnel using Adept.
- Collaborate with process owners, Engineering, IT, and GMP teams to capture, draft, and finalize documentation reflecting system usage, configuration, and control changes within Adept.
- Translate complex system configurations, workflows, and specifications into clear, concise, and user-friendly documentation suitable for a diverse audience (operators, engineers, quality, and management).
- Ensure documents meet regulatory requirements (21 CFR Part 11 considerations, data integrity principles, and company Data Governance standards) and align with site-specific procedures.
- Develop templates and style guides for consistency across SOPs, Work Instructions, and training materials; maintain version control and proper archival processes.
- Collaborate with Engineering to assist in user acceptance testing (UAT) documentation, traceability matrices, and change control records.
- Manage review, approval workflows, and document control activities within the appropriate electronic document management system (eDMS) and Adept-related modules.
- Support training program design by generating training modules, job aids, and assessment materials; track completion and maintain Training Records.
- Contribute to knowledge transfer, audience mapping, and the creation of onboarding materials for new users of Adept.
- Maintain a library of best practices, QA notes, and Lessons Learned to inform continuous improvement.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Technical Communication, or a related field (or equivalent experience in GMP environments).
- Proven experience writing GMP-compliant SOPs, Work Instructions, and Training Records in the pharmaceutical or biotechnology industry.
- Strong understanding of pharmaceutical manufacturing processes, cGMP concepts, data integrity, and document control practices.
- Hands-on experience with Adept by Synergis Software (or equivalent E-SOP/Manufacturing Execution/Document Management systems) and familiarity with its documentation and training modules.
- Ability to translate technical content into clear, actionable documentation with structured formats (Headers, Definitions, Steps, Roles, Visuals).
- Experience with change control processes, validation lifecycle, and system/software qualification documentation.
- Proficiency with Microsoft Office suite and document management tools; comfort with authoring tools, templates, and version control.
- Excellent written and verbal communication, interviewing, and cross-functional collaboration skills.
- Detail-oriented with strong organizational, time-management, and prioritization abilities; capable of meeting tight regulatory timelines.
- Knowledge of data governance, 21 CFR Part 11 considerations, and regulatory expectations for electronic records.
Preferred Qualifications
- Experience creating content for Adept-specific workflows, scripts, or configuration guides.
- Familiarity with LIMS/ELN environments or other GMP IT systems.
- Experience in producing training records that tie to competency matrices and personnel qualifications.
- Any certifications in technical writing, quality systems, or regulatory affairs (e.g., DWIT, ASQ certifications) are a plus.
What You’ll Deliver
- A complete set of GMP-compliant SOPs, Work Instructions, and Training Records for Adept usage and related processes.
- Clear templates and style guides to standardize future documentation.
- Training materials and assessment tools aligned with competency requirements.
- Documentation that supports audit readiness and regulatory inspections.
JSG has been named to three prestigious lists from Staffing Industry Analysts (SIA)’s: Largest Staffing Firms in the U.S., Largest Engineering Staffing Firms in the U.S., and Largest Staffing Firms in Canada.
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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