GMP Technical Writer — Pharma Documentation (Contract)

Actalent; Sacramento (CA); On-site; USD 55,000 - 76,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

401(k) retirement plan eligibility

Onsite in Sacramento

Job summary

Actalent is seeking a Technical Writer to support documentation in a regulated pharmaceutical GMP environment in Sacramento, CA. You will author, review, and revise GMP documents, SOPs, deviations, CAPAs, and validation records, collaborating with Manufacturing, Engineering, Validation, and Quality teams.

The position is a 6-month contract with potential extension or conversion, day shift, requiring independent work, strong attention to detail, and ability to manage multiple projects while

Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline preferred.
• 3+ years of technical writing experience in a regulated industry.
• Experience authoring GMP documentation in a pharmaceutical, biotechnology, medical device, or other FDA-regulated environment.
• Strong experience writing SOPs, batch records, deviations, investigations, CAPAs, change controls, and validation and qualification documentation.

Responsibilities

• Author, edit, and maintain GMP documentation, including batch records, SOPs, deviations, investigations, CAPAs, change controls, QC documentation, and validation records.
• Partner with Manufacturing, Engineering, Validation, and Quality teams to gather information and translate it into compliant documentation.
• Review existing documentation and workflows to identify gaps and drive improvements.
• Ensure all documentation complies with FDA regulations and cGMP.
• Support quality system activities within electronic QMS.
• Coordinate document revisions and updates due to process improvements and regulatory changes.
• Maintain document control, traceability, and lifecycle compliance.

Skills

Technical writing

FDA/cGMP knowledge

SOP writing

Cross-functional collaboration

Attention to detail

Independent work

Project management

Communication skills

Education

Bachelor's degree in science/engineering

Job description

Actalent is seeking a Technical Writer to support documentation in a regulated pharmaceutical GMP environment in Sacramento, CA. You will author, review, and revise GMP documents, SOPs, deviations, CAPAs, and validation records, collaborating with Manufacturing, Engineering, Validation, and Quality teams.

The position is a 6-month contract with potential extension or conversion, day shift, requiring independent work, strong attention to detail, and ability to manage multiple projects while