Position Summary: Catalent Pharma Solutions in Kansas City, MO is hiring a Pre-Production Coordinator for the Clinical Services Group. This person will serve as a liaison between Project Management and Packaging Operations and be 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. This person will also ensure that the work that is carried out by Packaging Operations follows regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).
This is a full-time role position: Monday – Friday, 8:00AM-4:00PM. 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 in Somerset, NJ is home to oral solid dose manufacturing operations as part of the Oral and Specialty Delivery (OSD) business unit. On site we have our state-of-the-art laboratory, clinical, and commercial manufacturing plant for oral dose forms in addition to being the Catalent Center of Excellence for handling Highly Potent Active Pharmaceutical Ingredients. Catalent is committed to a Patient
First culture through excellence in quality andcompliance, and to the safety of every patient, consumer, and Catalent employee. The Role Accurately create batch records within the timeframe allotted on the project timeline, while balancing other responsibilities and tasks, ensuring right first time. Communicate with Project Managers any special instructions, revisions, restrictions, documentation requirements, etc.
Inserting digital pictures and diagrams to improve the packaging quality on the packaging floor in accordance with SOPs and cGMPs. Interact with Production, Quality Assurance, Label Control, and Packaging Engineering personnel to communicate project requirements and gather appropriate paperwork for batch records. Calculate drug product and components, as well as check release status, to ensure ample quantities are available prior to the packaging process.
Work with clients to facilitate response to customer questions, provide batch records, etc. Peer review Primary & basic Secondary batch records, as required, for completeness/appropriate documentation and ensure all corrections to the packaging batch record and label request(s) are corrected accurately prior to submitting for final review. Coordinate
Ordering & Receiving activities for Catalent-supplied items related to: requesting/setting up Materials IDs, requesting and creating specifications/methods, submitting purchase requisitions. Onboard client supplied drug & components including setting up material IDs, creating onboarding paperwork for receiving & sampling and uploading documents to the Material Tracker (or current tracking system for materials). Report any issues that may impact the timelines specified for packaging studies.
All other duties as assigned; The Candidate Two years of experience in Packaging and/or Technical Writing preferred, but not required. High School Diploma or GED required, Associates or Bachelors degree preferred Highly proficient in basic computer functions, as well as MS Office and other basic software Excellent writing and communication skills, especially technical writing Proven ability to teach or coach others 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 Employee Stock Purchase Program 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 matchand Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement- Let us help you finish your degree or earn a new one 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 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 DisabilityAccommodationscatalent.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 spamcatalent.com for us to investigate with local authorities.
Scientific / QA
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