Clinical Production Specialist- 2nd Shift

Catalent Pharma Solutions•Philadelphia, PA

1d•Onsite

About The Position

Catalent’s Philadelphia-area facility is a global Center of Excellence for Clinical Supply Packaging, providing GMP secondary packaging and clinical labeling services, including manual to fully automated packaging solutions and temperature-controlled options. The Clinical Production Specialist is responsible for the overall execution, training, monitoring, and supervising clinical production staff within specific clinical packaging batch record operations. This role requires a general knowledge of clinical applications related to randomization schedules, open label, blind labeling, study collection, and treatment groups.

Requirements

High School Diploma or General Education Diploma is required
At least one year of Clinical, contract or production experience required
Computer literate (Microsoft Word) is required
Working knowledge of relevant cGMPs, DEA and OSHA rules and regulations is required

Nice To Haves

Associate degree or some college courses taken preferred
Clinical Trial Manufacturing and Packaging experience preferred
JD Edwards experience or similar ERP systems preferred

Responsibilities

Monitors, organizes and performs all functions associated with packaging of clinical trial supplies and assures compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations in the specific production batch record assigned
Oversees specific batch record operations assigned to which includes both primary and secondary production rooms equipped with various pharmaceutical packaging equipment including but not limited to: automated bottle line, form, fill and seal equipment, card sealing, vial and ampoule labelers, pouch equipment and medical device tray sealing
Responsible for production involving manual and automated application of randomized labels on bottles, cards, cartons, kits, vials, syringes and ampoules
Responsible for insuring correct placement of multiple look-alike product combinations in blister units, cards and bottles
Responsible for maintaining and ordering personnel, safety, disposable and support packaging supplies for specific assigned production room operation
Responsible for entering data accurately in batch records and logbooks
Must review completed manufacturing and packaging batch records in a timely manner
All other duties as assigned

Benefits

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!
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