Document Coordinator I

Our Work Matters

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

Why Kindeva?

• Purpose-driven work environment
• 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:

1. 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.
2. 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.
3. 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.
4. 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.
5. Tracking and transfer support: Create and maintain QA Documentation tracking databases and prepare site transfer cases, as needed.
6. 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.
7. Business coverage: Support occasional late-night or weekend work based on business needs.
8. Other duties as assigned.

BASIC QUALIFICATIONS

Minimum Associates degree in a science field

Preferred:

Experience in a GMP environment, preferably within Quality. 

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