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Clinical Trial Returns Specialist

2 months ago

Kansas City, Missouri, United States Catalent Inc Full time

Catalent Inc. is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Clinical Trial Returns Specialist to join our team in Kansas City, MO.

Job Summary:

Catalent's Clinical Development and Supply (CDS) team is responsible for the processing of returned clinical trial medications. As a Clinical Trial Returns Specialist, you will play a critical role in ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP), and standard operating procedures (SOPs).

Key Responsibilities:

  • Prepare and complete documentation in compliance with good documentation practices, SOPs, and cGMP.
  • Manage assigned returned studies and effectively communicate project status to clients.
  • Inspect drug product, components, and other return clinical supplies for defects as requested by clients.
  • Ensure a high-quality standard of work by reporting any deviations to standard operating procedures or returns processing protocols to management.
  • Follow safety and manual handling guidelines and accurately review returns processing records to ensure instructions are followed in accordance with SOPs.
  • Operate powered industrial truck lifts safely and reliably.
  • Ensure daily targeted productivity goals are achieved.
  • Complete verification of material for destruction.
  • Able to respond to questions and provide guidance to clients on returned goods and destruction matters, as required.
  • Responsible and able to effectively lead return team members through a returns project set-up and process training and take ownership for outcome.
  • Lead PSQDC meetings as assigned.
  • Writes return study protocols.
  • All other duties as assigned.

Requirements:

  • High School diploma, or equivalent required.
  • 3+ years of clinical trial packaging or related pharmaceutical operations experience preferred.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Possess knowledge of cGMP regulation and practices.
  • Self-motivated, disciplined, focused, works well under pressure.
  • Ability to work very effectively and efficiently under pressure to meet competing workplace demands.
  • Above average computer skills including, but not limited to Microsoft Word, Microsoft Excel, and Inventory Management System.
  • Develops project management and communication skills to effectively lead projects and interact with clients.
  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.

Why Catalent:

  • Defined career path and annual performance review and feedback process.
  • Diverse, inclusive culture.
  • Positive working environment focusing on continually improving processes to remain innovative.
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
  • 152 Hours + 8 paid holidays.
  • Several Employee Resource Groups focusing on D&I.
  • Dynamic, fast-paced work environment.
  • Community engagement and green initiatives.
  • Generous 401K match.
  • Company match on donations to organizations.
  • Medical, dental, and vision benefits effective day one of employment.
  • Tuition Reimbursement.
  • WellHub program to promote overall physical wellness.
  • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.