GMP Manufacturing Documentation Writer

PolyPeptide US; Torrance (CA); On-site; USD 50,000 - 59,000; Full time

Job summary

PolyPeptide US is seeking a Technical Writer – Manufacturing Documentation in Torrance, CA, to develop, revise, and maintain GMP manufacturing documentation, including SOPs, MBRs, and work instructions.

You will partner with Manufacturing and Quality teams to translate complex processes into clear, accurate instructions, support change control, and ensure compliance across documents. Strong writing and collaboration are essential.

Qualifications

• Bachelor’s degree in a science-related field.
• Minimum of 2 years of GMP manufacturing, technical writing, operations, or another regulated environment.
• Experience creating or revising controlled manufacturing documentation preferred.

Responsibilities

• Draft, edit, and revise SOPs, Master Batch Records, work instructions, cleaning procedures, and controlled forms.
• Translate technical and manufacturing information into clear, accurate documentation.
• Partner with manufacturing subject matter experts to verify production processes.
• Observe manufacturing activities to ensure procedures reflect current practices.
• Ensure documentation meets GMP requirements and internal standards.
• Process document changes through the electronic document management system.
• Maintain version control, approvals, and document release/archival processes.
• Incorporate updates related to deviations, CAPAs, and process changes.
• Collaborate with cross-functional teams including QA, Packaging, Validation.
• Support development of training materials and communicate document changes.
• Review documents for consistency, clarity, and data integrity.
• Identify opportunities to improve documentation quality and usability.

Skills

Technical writing

Editing

Proofreading

Detail orientation

MS Office

Electronic Document Management Systems

Education

Bachelor’s degree in a science-related field

Tools

DGMS (Document Management)

Job description

PolyPeptide US is seeking a Technical Writer – Manufacturing Documentation in Torrance, CA, to develop, revise, and maintain GMP manufacturing documentation, including SOPs, MBRs, and work instructions.

You will partner with Manufacturing and Quality teams to translate complex processes into clear, accurate instructions, support change control, and ensure compliance across documents. Strong writing and collaboration are essential.