Production Specialist

Clinical Production Specialist

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

The Candidate

• 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.

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.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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