Quality Compliance Associate

Quality Compliance 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.

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.

The Quality Compliance Associate is responsible for the management of physical records and documents in support of Pre-Commercial and Commercial Operations and will assist in the document provision for Commercial Registration and On-Market Products.  The Quality Compliance Associate will support Client Audits and Regulatory Agency Inspections.

The Role

• Maintain hardcopy documentation and records, stored in Catalent on-site Record Retention Rooms with appropriate protection from fire, water and other damage.

• Issue and control site notebooks and logbooks

• Maintain and control physical records through its retention period (this includes routine filing, such as in training record folders, and assisting with curriculum review).  Archive site records to the off-site storage provider.

• Oversee Records Retention Room Control processes; ensure process is maintained for check in/out of records in inventory rooms; build process as needed to allow records to be removed from Record Retention Room, ensure return and filing/reconciliation.

• Ensure the list of personnel with access to the Records Retention Rooms is evaluated according to Catalent procedures to prevent unauthorized access of personnel to the retention rooms.

• Ensure physical record safety and security throughout the retention period, through appropriate storage, filing, access and inventory control measures to assure compliance.

• Assign, prepare, issue and manage lifecycle of laboratory notebooks and logbooks.

• All other duties as assigned.

The Candidate

• Bachelor’s degree with at least 1 year of documentation management experience or;

• Associate degree with at least 2 years of documentation management experience.

• Equivalent applicable years of experience in combination with education will be considered.

• Average to proficient computer skills in word processing and internet-based applications.

• Position requires the capacity to handle and manipulate objects using hands and arms.

• Position requires the ability to safely lift and maneuver 30 pounds.

• Sitting for long periods of time using a computer.

Why You Should Join Catalent 

• Competitive medical benefits and 401K 

• 152 hours of PTO + 8 Paid Holidays 

• Dynamic, fast-paced work environment 

• Opportunity to work on Continuous Improvement Processes

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.

Visi