Quality Systems Coordinator

Catalent•Manassas, VA

1d•Onsite

About The Position

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.

Requirements

HS Diploma or GED required.
2+ years of experience in a GMP-regulated manufacturing or consumer health/OTC environment.
Strong knowledge of quality systems (Deviations, CAPA, Change Control, Training, Documentation, Batch Records).
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook); ability to create reports, trackers, and presentations.
Strong communication and interpersonal skills; able to work collaboratively across departments and with external vendors.
Demonstrated ability to bring structure and accountability in environments requiring process discipline.

Nice To Haves

Bachelor’s degree in a scientific or technical discipline preferred (e.g., Chemistry, Biology, Quality, Engineering). Equivalent experience considered.
Experience supporting raw material specifications, SOP management, and training materials development preferred.
Power BI skill is preferred.

Responsibilities

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.