• Pharmaceutical Pre Production Coordinator

    Catalent Pharma SolutionsKansas City, MO 64106

    Job #1003839899

  • 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

    Position Summary

    The Kansas City Pre-Production Coordinator serves as a liaison between Project Management and Packaging Operations. The Pre-Production Coordinator is 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. Ensures that the work that is carried out by Packaging Operations is in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).

    Work Hours - Monday through Thursday, 2:00 pm - 11:00 pm; Friday 12:00 pm to 4:00 pm

    Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures and packages pharmaceutical and other products for customers in nearly 100 countries, employs approximately 8,000 employees at 30 facilities worldwide and generates more than $1.7 billion in annual revenue. Among its core offerings, develops and manufactures oral and sterile pharmaceuticals in nearly all major dosage forms, and offers proprietary technologies used in many well-known prescriptions and over-the-counter products. Catalent is also the largest contract packager of pharmaceuticals.

    The Role

    • Accurately create Clinical packaging batch records (excluding Double-Blind studies) using source documents provided by the Project Manager (i.e. Packaging Summary/Packaging Request/Label approvals/etc.)

    • Communicating 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 checking release status, to ensure ample quantities are available prior to the packaging process.

    • Assign job output material IDs and Lot numbers within current inventory system.

    • Peer review Primary & basic Secondary batch records, as required, for completeness/appropriate documentation an ensuring all corrections to the packaging batch record and label request(s) are corrected accurately prior to submitting for final review.

    Material Tracking/Ordering

    • Coordinate Ordering & Receiving activities for Catalent-supplied items related to: requesting/setting up Materials IDs, requesting and creating specifications/methods, submitting purchase requisitions.

    • Onboarding of 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.

    The Candidate

    Education or Equivalent:

    • HS Diploma required; Associates or Bachelor's Degree in Biology/Chemistry/Pharmacy preferred

    Experience:

    • Two years of experience in Packaging and/or Technical writing preferred.

    Knowledge/Skills Requirements:

    • Able to work - Monday through Thursday, 2:00 pm - 11:00 pm; Friday 12:00 pm to 4:00 pm on a regular basis

    • Possess a high level working knowledge of departmental practices and procedures.

    • A full complement of business computer literacy skills with exposure to inventory control database is preferred.

    • Must work with little or no direct supervision.

    • Must be detail-oriented and organized, with an emphasis on quality, with some knowledge of clinical trial packaging procedures desired

    • Ability to prioritize and manage multiple tasks and stay focused.

    Physical Requirements:

    • Frequent sitting, standing, walking, climbing ladders/steps, reading of written documents and use of computer monitor screen, reaching with hands and arms, stopping, kneeling, crouching, understand verbal and written communication, bending, grasping, listening.

    • The ability to differentiate colors is required.

    • Position may require a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.

    • Position will require access into some GMP areas including; Primary Packaging, Secondary Packaging, and storage/dock areas.

    Business Environment:

    • Fast-paced

    • Performance Driven

    • Customer Focused

    • Collaborative and Inclusive

    • Professional Office Setting

    • Confidential Department

    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

    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 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 ~~~/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 ~~~. 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.

    Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.

    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 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.

    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, or protected veteran status. 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 along with the job number and title to ~~~. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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