Document Coordinator I

Kindeva; Maryland Heights (MO); On-site; USD 55,000 - 85,000; Full time

Job summary

Kindeva Drug Delivery is seeking a document control coordinator to manage GMP documents within the Quality Document Management System (QDMS). You will format, issue, reconcile, and archive SOPs, master batch records, specifications, lab methods, and related documents to support compliant manufacturing.

The role involves preparing master GMP documents, maintaining tracking databases, supporting site transfers, and providing SME input on document management processes.

Qualifications

• Associate degree in a science field required.
• Experience in GMP environment preferred, especially within Quality.

Responsibilities

• Controlled document management: create, format, revise, issue, reconcile, archive GMP documents and logbooks in accordance with procedures.
• QDMS compliance: administer GMP documentation within the Quality Document Management System (QDMS).
• Batch record support: issue and reconcile laboratory, production, replacement, redlined, and related batch records.
• Record retention and archiving: maintain records and archive batch records and related documents.
• Tracking and transfer support: create and maintain QA documentation tracking databases and site transfer cases.
• Process and project support: act as document author and SME for document management processes and QA activities.
• Business coverage: support occasional late-night or weekend work based on business needs.
• Other duties as assigned.

Education

Associate degree in a science field

Job description

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.

Why Kindeva?

• Significant growth opportunities
• Collaborative, team-oriented culture
• Direct impact on patient care
• Industry-leading pharmaceutical innovation

ROLE SUMMARY

The document control coordinator is responsible for coordinating the system by which changes are made to controlled GMP documents such as SOPs, Forms, Batch Records, printed material, specifications, device design documents (DHF documents) etc. This includes issuing production batch records as well as maintaining several Tracking databases; formatting various document types to conform to approved templates within the Quality Document Management System (QDMS); finalizing approved GMP documents and ensuring copies are distributed to contract customers and Regulatory Affairs as needed. Responsible for preparation and maintenance of master GMP documents.

ROLE RESPONSIBILITIES

Essential responsibilities include:

• Controlled document management: Create, format, revise, issue, reconcile, archive, and maintain GMP-controlled documents and logbooks in accordance with applicable procedures. Document types include SOPs, master batch records, specifications, laboratory methods, protocols, Design History File documents, training materials, reference manuals, job aids, and forms.
• QDMS compliance: Administer GMP documentation within the Quality Document Management Systems (QDMS), including document properties, formatting, change summaries, reviewer assignments, and approval routing to support compliance with applicable procedures, policies, regulations, and quality requirements.
• Batch record support: Issue and reconcile laboratory, production, replacement, redlined, supermarket, media fill, machine trial, experimental, and research batch records in accordance with production schedules and approved protocols.
• Record retention and archiving: Maintain company records within the record retention program. Scan, upload, and archive batch records, sterilization records, raw material test reports, cleanability assessments, and related records in the applicable electronic archive, shared file, or archival system in accordance with site SOPs and retention requirements.
• Tracking and transfer support: Create and maintain QA Documentation tracking databases and prepare site transfer cases, as needed.
• Process and project support: Serve as document author and subject matter expert for document management processes, support department projects, and perform assigned QA Documentation activities.
• Business coverage: Support occasional late-night or weekend work based on business needs.
• Other duties as assigned.

BASIC QUALIFICATIONS

MinimumAssociates degree in a science field

Preferred:

Experiencein a GMP environment, preferably within Quality.

Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.