Clinical Production Specialist
Company: Catalent Pharma Solutions, Inc.
Posted on: June 12, 2021
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
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. 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
- 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
- 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
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
- Computer literate (Microsoft Word). JD Edwards experience or
similar ERP systems preferred.
- Working knowledge of cGMPs, DEA and OSHA rules and
- 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
- 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
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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