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Catalent Pharma Solutions Pre-Production Coordinator in Kansas City, Missouri

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

This role will report directly to the Manager of Pre-Production.

The Kansas City CSS Pre-Production Coordinator serves as a liaison between Project Management and Packaging Operations. Responsible for assisting in the coordination of activities related to creating packaging batch records and other GMP documents & materials that comply with the clients’ scope. Ensures that the work that is carried out by Packaging Operations is in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).

The primary responsibilities of this position include creating batch records based on source documentation while identifying customer needs and the ability to prepare batch records following GMP standards. The individual will be client interacting to facilitate customer questions. This position will coordinate receiving of materials as associated with PO generation and zero-dollar Purchase Orders. Furthermore, this position may participate in the internal or client audit program and may assist with investigations related to packaging.

The Role

  • Assist Project Managers with development of clinical, stability, and commercial packaging protocols and materials

  • Create batch records based on project source documentation from Project Management including primary, secondary labeling and kitting and assembly

  • Interact with Production, Quality Assurance, Label Control, and Packaging Engineering personnel to communicate project requirements and gather appropriate paperwork for batch records

  • Client interaction and communication to facilitate responses to customer questions and provide batch records etc., as required.

  • Support project timelines as directed by Management ensuring that key project millstones are met and projects progress in a satisfactory and timely manner.

  • Work with Label Control to obtain item numbers for labels and randomization copies for batch records

  • Coordinate receiving and distribution activities, related to item master requests, zero-dollar Purchase Order generation, Shipment request completion, as required

  • Understand and adhere to standard operating procedures (SOPs) in a GMP setting

The Candidate

  • A High School Diploma or GED is required; Associate’s or Bachelor’s degree is preferred

  • Two years of experience in Packaging and/or Technical writing preferred

  • GMP experience is preferred

  • Must be computer literate with past experience using spreadsheets and word processing programs

  • Ability to prioritize and manage multiple tasks and stay focused

  • Customer orientation

  • Integrity; has an uncomplicated and uncompromising understanding of right from wrong, both publicly and privately; values a fair playing field for everyone, and demonstrates courage of conviction for what they believe

  • Interpersonal skills; is other-oriented rather than focused on self; listens effectively and communicates ideas and opinions clearly; is assertive while showing respect and positive regard for others; demonstrates an appreciation for people with different background and points of view

Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually

  • Potential for career growth within an expanding team

  • Defined career path and annual performance review and feedback process

Catalent’s Standard Leadership Competencies

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.

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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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