QA Batch Disposition & Documentation Coordinator

INCOG BioPharma Services

Fishers (IN)

On-site

USD 60,000 - 75,000

Full time

13 hours ago
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Job summary

INCOG BioPharma Services in Fishers, IN is seeking a QA Batch Disposition Department Coordinator to support the QA Batch Review and Disposition team. This role focuses on organizing GMP documentation, tracking batch records, and reporting metrics to QA leadership.

The ideal candidate has 2+ years in administration/coordination or document control, strong organization, and proficient Microsoft Office skills.

Qualifications

  • A minimum of 2 years of relevant administrative, coordination, or document control experience.
  • Proven ability to manage multiple tasks and priorities in a fast-paced environment.
  • Strong organizational and time management skills, with a high degree of attention to detail.
  • Excellent written and verbal communication and interpersonal skills.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
  • Ability to respond to the unexpected quickly and constructively, while balancing tact and directness.

Responsibilities

  • Organize, control, and track GMP documentation (e.g., executed Batch Records, forms, and supporting records).
  • Transport documentation to and from the QA Batch Review Space.
  • Maintain logbooks for document issuance, retrieval, and tracking.
  • Support deviation investigations, root cause analysis, and CAPA with timely documentation.
  • Prepare batch record review packages and client documentation requests.
  • Collect, coordinate, and report departmental and batch release metrics.
  • Maintain batch release trackers and dashboards for visibility.

Skills

Document control
Coordination
Microsoft Office
Attention to detail
Communication

Tools

eDMS
eQMS (Veeva)
Power BI
Smartsheet

Job description

INCOG BioPharma Services in Fishers, IN is seeking a QA Batch Disposition Department Coordinator to support the QA Batch Review and Disposition team. This role focuses on organizing GMP documentation, tracking batch records, and reporting metrics to QA leadership.

The ideal candidate has 2+ years in administration/coordination or document control, strong organization, and proficient Microsoft Office skills.

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