Catalent
Consumer Health
QualitySystemsCoordinator
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Systems Coordinator at Catalent. Skills: Quality Systems, cGMP compliance, CAPA management. Coordinate resolution of Deviations. Coordinate completion of Deviations”
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
2+ years GMP experience, Knowledge of quality systems
Nice to Have
Bachelor's degree scientific or technical, Experience supporting raw material specifications, Experience SOP management, Experience training materials development, Power BI skill preferred
What You'll Do.
Coordinate resolution of Deviations
Coordinate completion of Deviations
Coordinate resolution of CAPAs
Coordinate completion of CAPAs
Coordinate batch record backlogs
Implement process improvements
Track Change Controls
Support audit preparation
Support inspection preparation
Coordinate training activities
Build culture of quality awareness
Establish process for training records
Escalate training record gaps
How You'll Work.
Team & Collaboration
Collaborating with functional teams; Partner with cross-functional teams; Work collaboratively across departments; Work with external vendors
Full Job Description
**Quality Systems Coordinator** **Position Summary** * **Work Schedule: M-F 8am-4:30pm** * **100% based on-site in Manassas, VA** Our Manassas, Virginia site is a part of the Consumer Health division and provides expanded capabilities in soft chews and lozenges. With extensive development and manufacturing expertise and a wide range of flavors, ingredients, and colors available, we can work with complex formulations to help create engaging new products consumers will love. The **Quality Coordinator** will play a critical role in supporting the Quality function by ensuring compliance with cGMP, SOPs, and regulatory requirements within the Consumer Health facility. **The Role** * Assist in leading and coordinating the resolution and completion of Deviations, CAPAs, and batch record backlogs, collaborating with functional teams or assignees to drive timely completion. * Partner with cross-functional teams to propose and implement process improvements for better visibility, accountability, and sustainability of quality systems, with the goal of avoiding future backlogs. * Support the management and tracking of Deviations, CAPAs, Batch Records, Change Controls, and related quality records to ensure timely follow-up and effectiveness. * Support preparation for internal and external audits and inspections and 24/7 inspection readiness. * Coordinate training activities, ensuring personnel are trained on relevant SOPs, policies, and quality procedures. * Assist in building a culture of quality awareness, accountability, and adherence to procedures across functions. * Assist in establishing process to maintain accurate training records and escalate gaps to management. * Other duties assigned. **The Candidate** * HS Diploma or GED required. * Bachelor’s degree in a scientific or technical discipline preferred (e.g., Chemistry, Biology, Quality, Engineering). Equivalent experience considered. * 2+ years of experience in a GMP-regulated manufacturing or consumer health/OTC envir
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