Job Title: Supply Chain Technical Writer II
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-Have Requirements:
- 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, PowerPoint) 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.
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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.