Pre Production Coordinator Jobs (NOW HIRING)

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

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 Pre-Production Coordinator. The 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).

This is a full-time, on-site hourly position. Monday Friday, 8am 3pm.

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

• 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, kitting and assembly
• Interact with Production, Quality Assurance, Label Control, and Package Engineering personnel to communicate project requirements and gather appropriate paperwork for batch records
• Item Master identification and creator of request forms, JD Edwards Router, BOM, Purchase Order, and Work Order creation, GSA set up
• Create Change Orders and drive resolution to changes required during production
• Support project timelines as directed by Management, ensuring that key project milestones are met and projects progress in a satisfactory and timely manner
• Deliver the packaging documentation within agreed upon timelines, ensuring Right First Time
• Work with Label Designers to obtain item numbers for labels and randomization copies for batch records
• All other duties as assigned

The Candidate:

• A high school diploma or GED is required
• Associates or Bachelor's degree is preferred
• Two years of experience in packaging and/or technical writing preferred
• GMP experience is preferred
• At least one year experience working in a pharmaceutical environment is preferred
• Experience working in preparation of packaging batch records, packaging, labeling, assembly, and distribution of clinical trial materials is preferred
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds

Why you should join 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 Let us help you finish your degree or start a new degree!
• WellHub 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.

Personal initiative. Dynamic pace. Meaningful work.