GMP Document Control Specialist

Kindeva Drug Delivery; Missouri; On-site; USD 52,000 - 78,000; Full time

Job summary

Kindeva Drug Delivery in the United States is seeking a document control coordinator to manage GMP documents, issue batch records and maintain the QDMS system. The role ensures compliant, timely distribution of master GMP documents and supports site transfer cases.

You will format documents to approved templates, reconcile and archive records, and serve as SME for document management processes, with occasional late-night or weekend work as needed.

Qualifications

• Associates degree in science required.
• Experience in GMP environment preferred.
• Familiar with GMP documentation practices.

Responsibilities

• Create, format, revise, issue, reconcile, archive GMP documents and logbooks per procedures.
• Administer GMP documentation within QDMS including change summaries, reviewer assignments, and approvals routing.
• Prepare and maintain master GMP documents and ensure distribution to stakeholders.
• Issue and reconcile batch records in line with production schedules and approved protocols.
• Support site transfer cases and act as SME for document management processes.

Skills

Document management

GMP awareness

SOPs

Education

Associate degree in science field

Tools

QDMS

Job description

Kindeva Drug Delivery in the United States is seeking a document control coordinator to manage GMP documents, issue batch records and maintain the QDMS system. The role ensures compliant, timely distribution of master GMP documents and supports site transfer cases.

You will format documents to approved templates, reconcile and archive records, and serve as SME for document management processes, with occasional late-night or weekend work as needed.