Manufacturing Support Team Coordinator
About The Position
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.
Requirements
- High School Diploma or General Education Diploma is required
- 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.
- Excellent written and verbal communications skills with internal and external customers
- Ability to work effectively under pressure to meet deadlines
Nice To Haves
- Bachelor’s Degree desired or equivalent experience in the pharmaceutical industry
- Thorough knowledge of Solid Dosage manufacturing preferred
Responsibilities
- 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.
Benefits
- 152 hours of PTO + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
