|
Production Supervisor - Philadelphia Pennsylvania
Company: Disability Solutions Location: Philadelphia, Pennsylvania
Posted On: 04/17/2024
Production SupervisorPosition SummaryCatalent Pharma Solutions in Philadelphia, PA is hiring a Production Supervisor.-- The Production Supervisor is responsible for training, monitoring and supervising clinical production staff.-- Responsible for employee assignments, safety, quality, production rates, material reconciliation, production reports, timelines and union policies. This position requires a working knowledge of clinical applications regarding study phases I through IV, randomization schedules, open label, blind labeling, dose titration, double blind, double dummy, study collation and treatment groups.This is a full-time position: Monday - Friday, 2nd Shift.Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging.-- Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.-- Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID--- safe storage labels for your studies. Single panel and Peel-ID--- safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.Catalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--The Role - Monitors, organizes and performs all functions associated with packaging of clinical trial supplies and assures compliance to good manufacturing practices, standard operating procedures, Food and Drug Administration, Drug Enforcement Agency and Occupational Safety and Health Administration rules and regulations.
- Works closely with Project Management to establish manufacturing and packaging protocol section of batch record for ongoing and future studies.
- Oversees both primary and secondary production areas 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.
- Employee performance evaluations, new employee hiring, disciplinary notices, employee termination, according to company guidelines and performance requirements as established in the union contact.
- Develops, reviews and edits related production standard operating procedures (operational, maintenance, cleaning) in Documentum program. Investigate and prepare out of specification reports and customer complaints related to production in TrackWise program.
- Must review completed manufacturing and packaging batch records in a timely manner. Responsible for handling the packaging of refrigerated and frozen clinical trial material.
- Responsible for daily employee training. Review and approval of production staff vacation and personal days, along with leave of absence requests.
- All other duties as assigned.The Candidate
- High school diploma or general education diploma is required.
- Bachelor of Science Degree in Health/Chemistry/Pharmacy related field is preferred.
- Minimum of 5 years Clinical, contract or production experience is preferred.
- Clinical Trial Manufacturing and Packaging experience is preferred.
- Computer literate (Microsoft Word), JD Edwards experience or similar enterprise resource planning systems preferred.
- Working knowledge of current good manufacturing practices, Drug Enforcement Agency and Occupational Safety and Health Administration rules and regulations preferred.
- Leadership and team building skills. Demonstrate ability to train, motivate, direct and supervise production personnel. Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
- Knowledge of packaging equipment in a Just-in-Time environment. Proven ability to develop Standard Operating Procedures.
- Individual will be required to stand and/or sit for long periods of time, occasionally lift 0-15 pounds; specific vision requirements include reading of written documents and frequent use of computer. Why you should join Catalent:
|
|