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Clinical Production Specialist

Company: Catalent Pharma Solutions, Inc.
Location: Philadelphia
Posted on: June 12, 2021

Job Description:

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Job Title

Clinical Production Specialist

Position Summary

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. The Clinical Production Specialist is responsible for safety, quality, production rates, material reconciliation, BRNRFT, and timelines adherence in the specific Production Batch Record operation assigned to.

The Role (daily 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 to.
  • 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.
  • Responsible for handling the packaging of refrigerated and frozen clinical trial material.
  • Security, accountability and reconciliation of controlled substance in clinical production operation assigned to.
  • Staging, reconciliation and inventory label generation in ERP system (JD Edwards).
  • Track, monitor and maintain production rates, labor hours and downtime.

The Candidate (requirements)

  • Minimum of a High School Diploma or GED equivalent. Some college experience preferred.
  • 1+ years clinical or production experience required.
  • Clinical Trial Manufacturing and Packaging experience preferred
  • Computer literate (Microsoft Word). JD Edwards experience or similar ERP systems preferred.
  • Working knowledge of cGMPs, DEA and OSHA rules and regulations.
  • Demonstrate ability to train and oversee production personnel during production operation execution.

Catalent's standard leadership competencies that are used to interview and for Performance & Development:

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Position Benefits

  • Competitive medical benefits and 401K
  • 19 days of PTO + 8 paid holidays
  • Ample opportunities for growth and development
  • Dynamic, fast-paced work environment

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 DisabilityAccommodations@catalent.com. 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.

Keywords: Catalent Pharma Solutions, Inc., Philadelphia , Clinical Production Specialist, Other , Philadelphia, Pennsylvania

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