Technical Writer

Location: Branchburg, NJ 08876

Work Arrangement: Fully Onsite (Initial onboarding and training are 100% onsite; minor flexibility, such as 1–2 remote days per month, may be evaluated later based on performance)

Position Type: 6-Month Contract (High potential for extension up to 12–18 months based on performance and business needs)

Interview Process: 1-Round Interview

Position Overview: We are seeking a Technical Writer II to support tissue manufacturing operations within the Supply Chain organization. This role focuses on end-to-end documentation lifecycle management: authoring, revising, and coordinating Standard Operating Procedures (SOPs), work instructions, job aids, and Change Controls to support day-to-day manufacturing and upcoming new product launches. The ideal candidate brings strong, hands-on procedural writing experience within a regulated industry (Pharma, Biotech, or Medical Device). While supply chain knowledge is beneficial, core technical writing expertise and hands-on change control experience are the primary requirements.

Key Responsibilities: Authoring & Revisions: Create, revise, and format GMP-compliant documentation, including SOPs, work instructions, forms, batch records/specifications, and job aids. Change Control Execution: Directly author, coordinate, and drive Change Controls through initiation, review, approval, and closure for a new product launch and process updates. Supply Chain Documentation: Partner with Subject Matter Experts (SMEs) across Material Management, Logistics, Shipping, Receiving, Material Movement, and Planning to capture accurate workflows. Compliance & Quality Alignment: Collaborate with Quality Assurance and Operations teams to ensure all documentation adheres to current GMP, regulatory guidelines, and internal formatting standards. CAPA & Continuous Improvement: Facilitate CAPA documentation closures, resolve documentation gaps/redundancies, and participate in manufacturing process improvement initiatives. Document Tracking: Follow up actively with cross-functional reviewers and approvers to meet project milestones and eliminate operational bottlenecks. Candidate Profile &

Qualifications: Must-

Experience: 3 to 6+ years of hands-on technical writing experience within a regulated manufacturing environment (Pharmaceutical, Biotechnology, Medical Device, or Tissue Manufacturing).Change Management: Direct experience authoring and managing Change Controls (not merely reviewing or providing supporting attachments).Document Mastery: Proven track record of drafting clear, concise SOPs, step-by-step work instructions, and job aids from scratch or complex redlines.

Communication Skills: Exceptional English verbal and written communication skills with the ability to translate complex technical/operational processes into standardized documentation. Software Proficiency: High proficiency in Microsoft Office Suite (Word, Excel, Power Point) and experience using Electronic Document Management Systems (EDMS).Preferred /

Nice-to-Have: Familiarity with Supply Chain workflows (warehousing, inventory planning, logistics, or cold chain shipping).Experience with root-cause analysis, deviations, or CAPA closure documentation. Bachelor’s degree in Technical Writing, English, Communications, Life Sciences, or a related discipline. For information on benefits, equal opportunity employment, and location-specific applicant notices. Click here: https://spectraforce.com/spectraforce-applicant-disclaimers-contingent/At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.