Quality Assurance Document Control Supervisor

Quality Assurance Document Control Supervisor

Position Summary

Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control (QADC) Supervisor. The QADC Supervisor will supervise the team and activities associated with batch record documentation, reviewing and approving batch records, and releasing batch records and finished product. They will have a deep understanding and values around patient and employee safety, will assist in the enforcement of GMPs and regulatory compliance through FDA and Catalent requirements, and will provide customer satisfaction and operational efficiency. As a QADC Supervisor, this position requires the individual to ensure that the group completes their tasks and meets target dates for both production and the client. Also responsible for participating in special projects and/or tasks and ensuring that all functions are being performed in compliance with SOPs.

This is a full-time position:
Monday - Friday, days.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission:
to help people live better, healthier lives.

This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role:


Responsible for ensuring batch record documentation aligns with activities performed and is compliant against Catalent procedures.
Manage workload against the schedule for production priorities, working closely with the Scheduling and Production, including coordination of overtime.
Responsibility for releasing supplies for distribution; Monitor distribution of work within the department, assigning tasks and making adjustments when necessary to meet commitments.
Publish daily review/release schedule and completed work report for previous day; Takes initiative to make decisions for QADC collectively with the QADC team.
Act as site subject matter expert for "Good Manufacturing Practices" and SOPs related to batch record documentation and release.
Act as lead investigator for all Problem Reports regarding batch record documentation and support Problem Reports led by Operations.
Interact with customers regarding questions, issues, metrics, batch records, etc; Respond to and investigate customer complaints.
Audit for compliance as pertains to Catalent SOPs, regulatory, & customer requirements.

Perform all related duties and/or other functions as required.

The Candidate:


High school diploma or general education diploma is required.
College degree or high school diploma with rel vant industry experience is preferred.
Previous Supervisory experience is preferred.
Good computer skills and knowledge of MS Office are a plus.
Good knowledge of the application of FDA cGMP's.

Individual will be required to stand and/or sit for long periods of time, occasionally lift 0-15 pounds.

Why you should join Catalent:


Defined career path and annual performance review and feedback process
Diverse, inclusive culture
152 hours of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Competitive salary with possible bonus potential
Community engagement and green initiatives
Generous 401K match and Paid Time Off accrual
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement - Let us help you finish your degree or earn a new one!
GymPass program to promote overall physical wellness

Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 ***. 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