Description:
We are looking for a QA Batch Disposition Department Coordinator who will support the QA Batch Review and Disposition team through project coordination, metrics reporting, and the control of GMP documentation at a new state-of-the-art contract development and manufacturing organization. Do you naturally create new ways to deliver exceptional results? We want to meet you! QA Batch Disposition Department Coordinator Summary Working closely with the Associate Director, QA Batch Review and Disposition, the QA Batch Disposition Department Coordinator will provide organizational, administrative, and documentation control support to an active team of QA Batch Review and Disposition professionals. The Department Coordinator will be key in maintaining the accuracy, completeness, and traceability of GMP documentation as it moves to and from the controlled QA Batch Review space until batch disposition. Are you skilled in document control, workflow coordination, and data consolidation/reporting in a regulated environment? Do you take pride in keeping records organized, accurate, and audit-ready? If so, we want to meet you!
Essential Job Functions:
Organize, control, and track GMP documentation (e.g., executed Batch Records, forms, and supporting records) in accordance with Good Documentation Practices (GDP) and site procedures.
Transport documentation to and from the QA Batch Review Space.
Maintain document issuance, retrieval, and tracking logs to ensure all records are accounted for throughout the QA batch record review and disposition lifecycle.
Retrieve and provide scanned records and supporting documentation to Quality Systems, Investigation Associates, and Deviation Writers to support timely deviation investigations, root cause analysis, and CAPA activities.
Support the QA Batch Review team with the preparation of batch record review packages and Client documentation requests to support on-time batch release activities.
Collect, coordinate, and report on departmental and batch release metrics (e.g., review cycle time, disposition turnaround time, right-first-time, and documentation error trends) to QA leadership.
Maintain batch release trackers and dashboards to provide visibility to batch status and upcoming disposition priorities.
Identify, recommend, and support implementation of improvements to departmental processes, tools, and workflows.
Coordinate with Document Control the archival of completed records following batch Disposition.
Support regulatory inspection and Client audit readiness by promptly retrieving requested batch records and maintaining an organized, audit-ready filing system within the QABR space..Assist in the preparation of reports, presentations, and other documents as needed.
Handle confidential and Client-proprietary information with discretion and professionalism.
Exemplify and take proactive approaches in terms of best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Special
Job Requirements:- 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).walk, stand, and transport documentation throughout the facility as needed.
- Proven customer service mindset; ability to build strong working relationships with internal customers.
- Ability to respond to the unexpected quickly and constructively, while balancing tact, negotiation, and directness. Additional Preferences:
- Experience in a GMP-regulated pharmaceutical or biopharmaceutical environment, or other regulated space, is a plus.
- Working knowledge of Good Documentation Practices (GDP), ALCOA+ data integrity principles, and the batch record lifecycle.
- Experience with eDMS, eQMS (e.g., Veeva), or document scanning and archival systems.
- Experience with metrics reporting and data visualization tools (e.g., Excel, Power BI, Smartsheet)
Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.
