Quality Assurance Document Control Associate

Quality Assurance Document Control Associate

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

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 Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Documentation Coordinator Associate (QADC).  The position requires the individual to prepare customer files, review and approve batch records, and release batch records and finished product.  The individual acts as the primary liaison to our customer’s quality assurance groups for batch record review and release.  The position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders. 

This is a full-time role position: Monday-Friday 2:00pm – 10:30pm, 2nd Shift. Hourly, Onsite.

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:

• Independently manage assigned projects or support the Project Management (PM) team from award. Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.
• Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures. Confirm proper randomization schedule utilization for correct patient treatment group assignment.
• Primary liaison with client for batch release. Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation.  Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.
• Ensure timely release of batch for protocol initiation date. Release batch within Scheduling database and within JDE inventory management system. Record and track errors and not-right-first-time to maintain departmental metrics.
• Archive batch documents onto shared drive and within archive room. Coach new QADC staff through day to day activities when needed. Communicates SQDC counter measures and safety issues to Quality Management.
• Ensures QADC metrics are met or takes action to correct. Complies with EH&S and 5S requirements for QADC.
• All other duties as assigned; 

The Candidate:

• Requires a High School Diploma or GED; Bachelor's degree preferred
• Must have basic computer skills, preferably with Microsoft Office and JDE
• Prefer experience in Documentation including document review, data review, and Standard Operating Procedures etc
• Previous Quality experience preferred
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• 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 
• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!
• WellHub- 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. 

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 [email protected]. 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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.