Returns Associate III

Position Summary:

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.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Clinical Development and Supply (CDS) Returns Associate III supports clinical trial projects through the processing of returned clinical trial medications that are returned by clinical research sites for destruction and ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). Although the main focus is in Returned Goods and Destruction, this position will also support other areas of operation as needed and as requested in order to support the needs of the business.

This is a full-time role position: Monday – Friday, days. 7:00AM – 3:30PM

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

• Prepare and complete documentation in compliance with good documentation practices, SOPs and cGMP;

• Manage assigned returned studies and effectively communicate project status to the client;

• Inspect drug product, components, and other return clinical supplies for defects as requested by the client;

• 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;

The Candidate

• 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 you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 19 days of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• 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

• Competitive salary

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• GymPass program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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 Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .