Job Details
Catalent Pharma Solutions in Kansas City, MO is hiring a
Pharmaceutical Production
Coordinator . At the direction of the Managers, Zone Managers or Pharmaceutical Manufacturing Leads, the
Pharmaceutical Production
Coordinator
is responsible for helping with JDE transactions/troubleshooting, in process batch record reviews, comment resolution for in process records and documentation preparation. The Pharmaceutical Production Coordinator is responsible for adhering to policies and procedures with an emphasis on regulatory related processes such as SOPs, cGMP and safety in compliance with the CFRs and meets the business needs of the organization.This is a full-time role position: Monday Friday, days.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 is committed to a Patient First culture through excellence in quality andcompliance, and to the safety of every patient, consumer, and Catalent employee.The RoleResponsible for ensuring cGMP compliance, general good housekeeping for the office area, communicating with Zone Managers, Pharmaceutical Manufacturing Leads and Pharmaceutical Technicians. Operating in a dynamic environment completing job tasks that range from simple to complex and/or multi-tasking.Print, issue and review Cleaning Batch Records at the request of the Zone Managers or the Pharmaceutical Manufacturing Leads.Submit work orders at the request of the Zone Managers or Pharmaceutical Manufacturing leads.Perform transactional reviews of JDEdwards for batch processing including inventory reconciliations for batches and production rooms. This includes performing commitments, troubleshooting error codes in JDE via the Mobile Execution Platform (MEP) or web based interface.Performing in process or day end reviews with high level of attention to detail to drive reductions in unplanned deviations due to documentation errors in batch records or inventory issues within JDE. JDE tasks must be performed accurately.Recommends changes and helps build training material to Operations Training Team, Pharmaceutical Manufacturing Lead or Managers in regard to errors being seen during inventory reconciliation or batch documentation review.Provides information to support core group metrics and efficiency increases. Supports customer requests as needed.Ability to wear required gowning required to work in the GMP manufacturing areas. Follows all Catalent safety procedures and identifies/communicates the necessary adjustments to address potential safety concerns. Will also ensure the proper use of PPE (Personal Protection Equipment)All other duties as assigned;The CandidateHigh School Diploma with 2+ years related work experience required; OR A technical degree or certification with 1+ years related work experience required.Must have a thorough knowledge of cGMP, FDA, MHRA and DEA guidelines and how to apply them effectively. Thorough knowledge of Solid Dosage manufacturing preferred.Experience maintaining high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs. GMP previous experience highly preferred.Excellent written and verbal communications skills with internal and external customers, peers and managers.Well organized with ability to multitask and work effectively under pressure to meet deadlinesIndividual 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 processDiverse, inclusive culture19 days of PTO + 8 paid holidaysSeveral Employee Resource Groups focusing on D&IDynamic, fast-paced work environmentEmployee Stock Purchase ProgramPositive working environment focusing on continually improving processes to remain innovativePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesCompetitive salary with quarterly bonus potentialCommunity engagement and green initiativesGenerous 401K matchand Paid Time Off accrualMedical, dental and vision benefits effective day one of employmentTuition ReimbursementGymPass program to promote overall physical wellnessPerkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categoriesCatalent 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 ...@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 ...@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice
HERE.
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