Technical Writer - Torrance
About The Position
At PolyPeptide, we partner with pharmaceutical and biotech companies to support the development and manufacturing of peptide-based therapies. We are looking for a Technical Writer – Manufacturing Documentation to create and maintain the controlled documents that guide our GMP manufacturing operations. This role is a strong fit for someone who enjoys combining technical understanding with strong writing skills. You will work closely with Manufacturing and Quality teams to translate complex processes into clear, accurate, and practical instructions that support consistent execution, compliance, and operational excellence.
Requirements
- Bachelor’s degree in a science-related field.
- Minimum of 2 years of experience in GMP manufacturing, technical writing, operations, or another regulated environment.
- Basic understanding of GMP documentation practices, version control, change management, and controlled templates.
- Ability to interpret manufacturing processes, batch records, and SOPs.
- Strong writing, editing, and proofreading skills.
- High attention to detail and documentation accuracy.
- Proficiency with Microsoft Office applications.
- Strong organizational and time-management skills.
- Ability to work effectively with cross-functional teams and technical subject matter experts.
- Adaptable, collaborative, and comfortable learning new processes.
- Strong compliance-focused mindset.
Nice To Haves
- Experience creating or revising controlled manufacturing documentation preferred.
- Experience with electronic Document Management Systems 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, and user-friendly documentation.
- Partner with manufacturing subject matter experts to understand and verify production processes.
- Observe manufacturing activities to ensure written procedures accurately reflect current practices.
- Ensure documentation meets GMP requirements, internal standards, and client expectations.
- Process document changes through the electronic document management system.
- Maintain version control, approval routing, document release, and archival activities.
- Incorporate updates related to deviations, CAPAs, process changes, and validation activities.
- Collaborate with Manufacturing, Quality Assurance, Packaging, Validation, and other cross-functional teams.
- Support the development of training materials and communication of document changes.
- Review documents for consistency, clarity, formatting, and data integrity.
- Help identify opportunities to improve documentation quality and usability.
Benefits
- equal opportunity employer
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
