Technical Writer - Manufacturing Documentation
PolyPeptide US · Torrance
Job description
About the role
PolyPeptide partners with pharmaceutical and biotech companies on peptide-based therapies, and is hiring a Technical Writer for its Torrance site. The writer creates and maintains the controlled documents that guide GMP manufacturing operations, working closely with Manufacturing and Quality teams to turn complex processes into clear, accurate instructions.
Key responsibilities
- Draft, edit and revise SOPs, Master Batch Records, work instructions, cleaning procedures and controlled forms.
- Partner with subject matter experts and observe manufacturing to ensure procedures match actual practice.
- Ensure documentation meets GMP requirements, internal standards and client expectations.
- Process document changes through the electronic document management system, including version control, approvals, releases and archival.
- Incorporate updates from deviations, CAPAs, process changes and validation activities.
- Collaborate with Manufacturing, QA, Packaging, Validation and other teams, and support training materials and communication of changes.
- Review documents for consistency, clarity, formatting and data integrity, and suggest improvements.
Required profile
- Bachelor's degree in a science-related field.
- Minimum 2 years of experience in GMP manufacturing, technical writing, operations or another regulated environment.
- Experience creating or revising controlled manufacturing documentation preferred.
- Strong writing, editing and proofreading skills, with a compliance-focused mindset.
Required skills
- Basic understanding of GMP documentation, version control, change management and controlled templates.
- Ability to interpret batch records and SOPs.
- Proficiency with Microsoft Office; experience with electronic document management systems preferred.
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Published 2 weeks ago
Expires 1 month from now
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PolyPeptide US
Torrance
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