Clinical Production Specialist- 2nd Shift

Catalent • Philadelphia, PA

1d • Onsite

About The Position

Catalent’s 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. 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.

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
• 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

• 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

• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees