Manufacturing Support Team Coordinator
Position Summary
Work Schedule: M-F 8am-4pm
100% based on-site in Kansas City
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.
At the direction of the MST Manager, the Manufacturing Support Team Coordinator functions include coordinating and scheduling required training topics, maintaining employee training files, developing and maintaining department-specific training materials, assisting with investigations, continuous improvement projects and manufacturing document generation & revision.
The Role
Coordinates equipment training for Department employees including, but not limited to, scheduling, assigning a trainer, and process training documentation.
Works with Training department to maintain rosters in learning management system (ComplianceWire).
Maintain department-specific training materials including, but not limited to, questionnaires, skill assessments, presentations, and one-point lessons.
Recommend changes and help build training material by collaborating with Pharmaceutical Manufacturing Leads and Operations Management.
Assist in writing SOPs/SEPs for prosses and equipment used by pharmaceutics and operations personnel.
Lead and collaborate with other site functions to identify and implement improvements to processes and procedures that simplify and improve efficiency while maintaining compliance with cGMPs and Catalent standards.
Must be able to interact with employees at all levels inside and outside of the department as well as clients.
Review documents with SME and Operations personnel to ensure they are accurate, executable and the formatting is consistent and harmonized.
Ensures 5S standards are met and maintained. Ensure that the facility is kept "tour ready" at all times and people/material/flow/cleaning and zone concepts are maintained at all times.
Ability to wear a PAPR (Powered Air Purifying Respirator) during manufacturing when required. 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 Candidate
High School Diploma or General Education Diploma is required
Bachelor's Degree desired or equivalent experience in the pharmaceutical industry
Candidate must have two years of progressive office experience and be computer literate and proficient in programs such as Microsoft Word, Microsoft Outlook, and Microsoft Excel.
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
Excellent written and verbal communications skills with internal and external customers
Ability to work effectively under pressure to meet deadlines
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 of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
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.
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) .
