GMP Technical Writer II: Change Control & CAPA Lead

Spectraforce Technologies, Inc.; Branchburg Township (NJ); In loco; USD 75.000 - 95.000; Tempo pieno

Descrizione del lavoro

Spectraforce Technologies, Inc. in Branchburg, NJ is seeking a Technical Writer II to support manufacturing operations and supply chain with GMP documentation and CAPA closures.

You will own the documentation lifecycle, gather SME inputs, and drive changes through an approved process in a regulated environment. Responsibilities include authoring and maintaining SOPs, work instructions, forms, and change controls; coordinating with QA, QC, and supply chain teams; and driving process improvements

Competenze

• Bachelor's degree in a scientific/technical discipline or 5+ years of relevant experience.
• 3–6 years of technical writing in a regulated manufacturing environment (Pharma/Biotech/Medical device).
• Proven experience writing SOPs, work instructions, Job Aids, and managing Change Controls.
• Highly proactive with ownership and drive to complete tasks.
• Excellent written and verbal English communication, across all levels.
• Proficiency with MS Word/Excel/PowerPoint; familiarity with QC, Change Control, and document management systems.

Mansioni

• Partner with Supply Chain SMEs, Quality, and other stakeholders to drive changes to completion.
• Author, revise, and maintain GMP documentation including SOPs, Work Instructions, Job Aids, specifications, forms, and Change Controls.
• Coordinate Change Proposals and facilitate CAPA closures to meet GMP requirements.
• Schedule meetings, gather inputs, and follow up with reviewers and approvers for timely completion.
• Develop and maintain standards for SOP content/format; ensure logical organization and compliance.
• Participate in Operations process improvements and optimize documentation workflows.

Conoscenze

Technical writing

Stakeholder management

SOP development

Change control

CAPA management

MS Office

Formazione

Bachelor's degree in science/engineering

Strumenti

Microsoft Office Suite

Quality/Change control systems

Document management system

Descrizione del lavoro

Spectraforce Technologies, Inc. in Branchburg, NJ is seeking a Technical Writer II to support manufacturing operations and supply chain with GMP documentation and CAPA closures.

You will own the documentation lifecycle, gather SME inputs, and drive changes through an approved process in a regulated environment. Responsibilities include authoring and maintaining SOPs, work instructions, forms, and change controls; coordinating with QA, QC, and supply chain teams; and driving process improvements