Clinical Production Specialist- 2nd Shift

Catalent•Philadelphia, PA

27d•Onsite

About The Position

Clinical Production Specialist Position Summary: Work Schedule: 2nd shift, Monday – Friday, 3:45pm - 12:15am. 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. Catalent Pharma Solutions in Philadelphia, PA is hiring a Clinical Production Specialist. The Clinical Production Specialist is responsible for the overall execution, training, monitoring and supervising clinical production staff within a specific clinical packaging batch record operation. This position requires a general knowledge of clinical applications regarding randomization schedules, open label, blind labeling, study collection and treatment groups. The Role 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

Requirements

High School Diploma or General Education Diploma is required, Associate degree or some college courses taken preferred
At least one year of Clinical, contract or production experience required
Clinical Trial Manufacturing and Packaging experience preferred
Computer literate (Microsoft Word) is required
JD Edwards experience or similar ERP systems preferred
Working knowledge of relevant cGMPs, DEA and OSHA rules and regulations is required
Individual will be required to stand and/or sit for long periods of time, occasionally lift 0-25 pounds
Willingness to work overtime, frequently in cold environments, and track, monitor and maintain production rates, labor hours and downtime.

Nice To Haves

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
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