Document Control Coordinator

About the role

PolyPeptide partners with pharmaceutical and biotech companies on peptide-based therapies, and is hiring a Production Document Control Coordinator in Torrance, CA. The role keeps manufacturing documentation accurate, complete, timely and compliant with cGMP and internal quality standards, working directly with Manufacturing teams in a regulated environment.

Key responsibilities

• Review manufacturing documentation for accuracy, completeness and cGMP compliance, including document and change-control reviews with minimal supervision and in-process reviews.
• Facilitate GDP corrections, resolve documentation errors and initiate and support the closure of process deviations.
• Prioritize reviews to support Manufacturing timelines and communicate concerns to Production leadership.
• Partner with Leads and Supervisors on recurring GDP and documentation issues and support document and process changes.
• Assist with creating and updating SOPs, forms and document-control procedures.
• Coach Production employees on documentation expectations and best practices, and suggest improvements to accuracy and review efficiency.

Required profile

• 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.
• Strong attention to detail, organization, prioritization and problem-solving skills; ability to coach others.

Required skills

• Working knowledge of cGMP, GDP and applicable FDA and ICH expectations.
• Proficiency with Microsoft Word, Excel and Outlook.