Clinical Coordinator

Catalent Pharma Solutions•Philadelphia, PA

1d•Onsite

About The Position

Clinical Coordinator Position Summary: Work Schedule: Monday - Friday, 9:00am to 5:30pm 100% on-site Catalent’s 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation. The primary responsibilities of the Clinical Coordinator include creating batch records based on source documentation while identifying customer needs and the ability to prepare batch records following GMP standards. The individual will be client interacting to facilitate customer questions. This position will coordinate receiving of materials as associated with purchase order generation and zero-dollar purchase orders.

Requirements

High School Diploma or GED is required
At least one year of experience working in a pharmaceutical environment is preferred
GMP experience is preferred
Previous experience working in preparation of packaging batch records, packaging, labeling, assembly and distribution of clinical trial materials is preferred
Individuals will be required to sit, stand, walk, and occasionally lift 0-15 pounds

Nice To Haves

Associate’s or Bachelor’s degree is preferred

Responsibilities

Assist Project Managers with development of clinical, stability, and commercial packaging protocols and materials
Create batch records based on project source documentation from Project Management including primary, secondary labeling and kitting and assembly
Interact with Production, Quality Assurance, Label Control, and Packaging Engineering personnel to communicate project requirements and gather appropriate paperwork for batch records
Item Master identification and creator of request forms, JD Edwards Router, BOM, Purchase Order, and Work Order creation, GSA set up
Create Change Orders and drive resolution to changes required during production
Work with Label Control to obtain item numbers for labels and randomization copies for batch records; Coordinate receiving and distribution activities, related to item master requests, zero-dollar PO generation, Shipment request completion, as required
All other duties as assigned

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO + 8 paid holidays
Generous 401K match
Medical, dental and vision benefits
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
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.