Quality Systems Coordinator

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 environment.

* Strong knowledge of quality systems (Deviations, CAPA, Change Control, Training, Documentation, Batch Records).

* Experience supporting raw material specifications, SOP management, and training materials development preferred.

* Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook); ability to create reports, trackers, and presentations. Power BI skill is preferred.

* 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.

Why You Should Join Catalent

* Spearhead exciting and innovative projects

* Fast-paced, dynamic environment

* High visibility to members at all levels of the organization

* 152 hours of PTO + 8 paid holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to Disabili This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives:
Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Thank you.

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