GMP Technical Writer – On-Site, Raleigh

Kelly Science, Engineering, Technology & Telecom; Raleigh (NC); Vor Ort; USD 55.000 - 65.000; Vollzeit

Zusammenfassung

Kelly Science, Engineering, Technology & Telecom is seeking Contract Technical Writers to support a GMP-regulated CAPA/SOP remediation initiative at a Raleigh, NC facility. The role involves updating and creating GMP-compliant documentation and collaborating with Quality, Manufacturing, and Laboratory teams to meet regulatory standards.

This on-site contract project requires 3+ years of GMP technical writing experience and offers a pay rate of $40-$47/hour for an initial 6-8 week engagement with

Qualifikationen

• 3+ years technical writing in a GMP-regulated environment.
• Bachelor's degree or equivalent in a regulated manufacturing field.
• Experience writing SOPs, batch records, work instructions, and lab documentation.
• Knowledge of CAPA processes and document control.

Aufgaben

• Revise and update SOPs to support CAPA closure activities.
• Author, revise, and format technical documentation, including batch records and laboratory forms.
• Translate input from Quality, Manufacturing, and Laboratory SMEs into compliant documentation.
• Ensure documents comply with cGMP and internal quality systems.
• Track documentation against project timelines and CAPA due dates.
• Collaborate with cross-functional teams to verify technical accuracy before approval.
• Utilize EDMS to draft, route, and maintain documentation.

Kenntnisse

Technical writing

GMP compliance

SOP development

CAPA processes

Documentation

Regulatory compliance

Independent work

Ausbildung

Bachelor's degree in scientific/technical field

Tools

MS Office

EDMS

Jobbeschreibung

Kelly Science, Engineering, Technology & Telecom is seeking Contract Technical Writers to support a GMP-regulated CAPA/SOP remediation initiative at a Raleigh, NC facility. The role involves updating and creating GMP-compliant documentation and collaborating with Quality, Manufacturing, and Laboratory teams to meet regulatory standards.

This on-site contract project requires 3+ years of GMP technical writing experience and offers a pay rate of $40-$47/hour for an initial 6-8 week engagement with