Missouri Healthcare Jobs

Jobs.mo.gov mobile logo

Job Information

Catalent Pharma Solutions Label Process Specialist in Kansas City, Missouri

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here (http://www.catalent.com/index.php/about-us/Catalent-Careers2)

This role reports to the Manager of Pre-Production and Label Control and is responsible for generating and managing the entire label process from the PM team ensuring on time accurate delivery of labels for all business unit label requirements.

  • Prepare, coordinate, design and generate Clinical Study Labels and Commercial Labels.

  • Prepare, coordinate, upload and generate Randomization Codes for use in clinical studies.

  • Perform above functions using the Electronic Labeling System (Clinicopia and PINN).

  • Verify all information conforms to GMP, Annex 13, Customer and Catalent regulatory requirements.

The Role

  • This position is responsible for generating and managing the entire label process from the PM team ensuring on time accurate delivery of labels for all business unit label requirements.

  • Prepare, coordinate, design and generate Clinical Study Labels and Commercial Labels.

  • Prepare, coordinate, upload and generate Randomization Codes for use in clinical studies.

  • Perform above functions using the Electronic Labeling System (Clinicopia and PINN).

  • Verify all information conforms to GMP, Annex 13, Customer and Catalent regulatory requirements.

Clinicopia

  • Generates randomization codes using appropriate labelling system (Clinicopia)

  • Uploads and verifies randomization codes using appropriate labelling system (Clinicopia)

  • Assign study numbers, randomization set up and importing into Clinicopia.

  • Responsible for kit structure design, setting up model protocols, orderable kits, work orders, and randomization setup in Clinicopia.

Global Scan Assembly (GSA)

  • Creation of master data within GSA

  • Creation of GSA packaging configurations.

  • Creation of GSA jobs, including the importing of verification data.

Label Design

  • Works closely with project management ensuring accurate timelines and labelling requirements.

  • Reviews client provided label text for accuracy and compliance with clinical study and regulatory requirements (client has overall responsibility for accuracy).

  • Generates, and revises as needed, Label Proofs for client review and approval.

  • Provides suggested label text layout f required to meet client study needs.

  • Approves Label Design in addition (Peer Review).

  • Generates multi language labels using appropriate labelling system and regulatory references. Understanding of the proper use of placeholders, bolding, font, label size set up, and page code usage. Be able to input symbols for foreign characters where the cut and paste function is not applicable.

Label Printing

  • Ability to clean, maintain calibrate and adjust printer settings. Must be able to properly use the Printronix printers. Know the differences in printer ribbons.

  • Printing job runs, verifying barcodes and the knowledge to generate re-prints and the paperwork required.

  • Ability to troubleshoot the printers. Escalate to printer vendor and manage the process and paperwork until issues are resolved.

  • Order and maintain label inventory.

General

  • Works closely with project management ensuring accurate timelines and labeling requirements.

  • Sets up Routers for each project.

  • Creates Master Bill of Materials.

  • Creates Work Orders for Label Printing.

  • Allocates lots of labels to Pick list for printing.

  • PS/PR (scope document) verification for accuracy and required information including approvals and to have the ability to assist and educate as needed.

  • Participates in TimeLine discussions to ensure client deliverables are met.

  • Manages label stock inventory based on client label specification requirements.

  • Determines use of label stock design and specifications based on client, material label is being applied and product storage requirements.

  • Participates in project kick-off meetings (internal and external) to establish clinical trial design and label requirements.

  • Requests, manages and maintains logbooks accurately for the purpose of designing labels in label room.

  • Knowledge of label regulatory requirements and an understanding of where to verify answers.

The Candidate

  • High School Diploma; Associates in Business, Graphics Design or related degree preferred.

  • 2-4 years of clinical labelling experience or related pharmaceutical operations experience preferred.

  • Computer/Technical experience strongly preferred.

  • Ability to hold self-accountable; set milestones and achieve results.

  • Ability to communicate effectively with engineers, technicians, customers, staff, and other personnel.

  • Ability to troubleshoot simple to complex process and equipment problems.

  • Demonstrated ability to plan and independently implement multiple projects.

  • High level of attention to detail.

  • Excellent documentation skills.

  • Strong problem solving and analytical skills.

  • Excellent written, verbal and interpersonal communication skills, including the ability to present information.

  • A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred.

Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually

  • Potential for career growth within an expanding team

  • Defined career path and annual performance review and feedback process

Catalent’s Standard Leadership Competencies

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

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 www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

DirectEmployers