Document Control Coordinator - 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 Production Document Control Coordinator to support manufacturing by ensuring production documentation is accurate, complete, timely, and compliant with cGMP and internal quality standards. This role is a strong fit for someone who is highly detail-oriented, organized, and comfortable working directly with Manufacturing teams in a regulated environment. The Production Document Control Coordinator plays an important role in keeping manufacturing documentation moving efficiently through the production process. You will review batch and production records, facilitate GDP corrections, support deviation activities, help implement document changes, and work directly with Leads, Supervisors, and Production personnel to improve documentation quality. This role combines GMP compliance, document review, problem solving, and cross-functional collaboration and has a direct impact on manufacturing efficiency, product quality, and on-time delivery.
Requirements
- Associate or Bachelor’s degree in Life Sciences or a related field preferred.
- 2+ years of experience in a GMP-regulated manufacturing, quality, or similar regulated environment.
- Experience reviewing production documentation or supporting manufacturing operations preferred.
- Working knowledge of cGMP, GDP, and applicable FDA and ICH expectations.
- Strong attention to detail and commitment to documentation accuracy.
- Ability to identify errors, inconsistencies, and compliance concerns.
- Strong organizational and prioritization skills.
- Effective communication and cross-functional collaboration skills.
- Ability to manage multiple priorities in a fast-paced manufacturing environment.
- Proficiency with Microsoft Word, Excel, and Outlook.
- Comfortable providing coaching and guidance to manufacturing personnel.
- Strong problem-solving and continuous-improvement mindset.
Responsibilities
- Review manufacturing documentation for accuracy, completeness, and cGMP compliance.
- Perform document and change-control reviews with minimal supervision.
- Conduct in-process or person-in-plant documentation reviews as needed.
- Facilitate GDP corrections and help resolve documentation errors.
- Initiate and support the closure of process deviations.
- Prioritize documentation reviews to support Manufacturing timelines and operational needs.
- Communicate documentation or process concerns to Production leadership.
- Partner with Leads and Supervisors to address recurring GDP or documentation issues.
- Support the implementation of document and process changes.
- Assist with creating and updating SOPs, forms, and document-control procedures.
- Provide coaching and guidance to Production employees on documentation expectations and best practices.
- Identify opportunities to improve documentation accuracy, consistency, and review efficiency.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
