Catalent

Consumer Health

QualitySystemsCoordinator

$65–85k ~AI est. Manassas, Virginia, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Quality Systems Coordinator at Catalent. Skills: Quality Systems, cGMP compliance, CAPA management. Coordinate resolution of Deviations. Coordinate completion of Deviations”

Industry & Context.

Consumer Health
Problems you'll solve

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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