This position is responsible for assisting in the coordination of activities related to the preparation of packaging batch records, packaging, labeling, assembly and distribution of clinical trial materials.
SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES included but are not limited to:
Assist Project Managers with development of clinical, stability and commercial packaging protocols and materials.
Write batch records based on project source documentation from Project Management
Interact with Production, Quality Assurance, Label Control, and Packaging Engineering personnel to communicate project requirements and gather appropriate paperwork for batch records.
Item Master creation, JD Edwards Router, BOM and Work Order creation
Client interaction and communications to facilitate responses to customer questions and provide batch records etc., as required.
Support project timelines as directed by project managers.
Deliver the packaging documentation within agreed upon timelines, ensuring right first time.
Work with Label control to obtain item numbers for labels and randomization copies for batch records
Coordinate receiving and distribution activities, related to item master creation, zero dollar PO generation, Shipment request completion and sales order updating, as required.
Understand and adhere to standard operating procedures (SOPs) in a GMP setting.
Development & Clinical Services
A High-school diploma or GED is required.
Associates or Bachelor's Degrees are preferred.
GMP experience is preferred.
At least one year experience working in a pharmaceutical environment is preferred.
Experience working in preparation of packaging batch records, packaging, labeling, assembly and distribution of clinical trial materials is preferred.
Strong organizational skills are required to assist Project Managers.
Must possess verbal, written and interpersonal communications skills appropriate for a business environment.
Must have ability to work with minimal supervision.
Must be detail-oriented and organized, with an emphasis on quality.
Must be computer literate with past experience using spreadsheets and word processing programs.
Working knowledge of Pharmaceutical and Biotech industries is desired.
Working knowledge of Project Management is desired.
Ability to prioritize and manage multiple tasks and stay focused.
Works well in team environments, as well as, in pressure situations under short timelines.
Walking, sitting, standing, ability to differentiate colors
Office environment and some work on the production floor and in warehouse environment.
Understands who our customers are, how they are motivated and the current and future business challenges they face. Demonstrates a strong bias toward service, quality and customer satisfaction.
Takes a collaborative approach by openly discussing issues in a way that brings out the best thinking, attitude and performance in others. Works effectively and productively with shared responsibilities.
Stays the course from start to finish. Does not confuse effort with results. Separates what is important from what is not. Demonstrates a persistent bias for action.
Has an uncomplicated and uncompromising understanding of right from wrong, both publicly and privately. Values a fair playing field for everyone, and demonstrates courage of conviction for what they believe.
Is other-oriented rather than focused on self. Listens effectively and communicates ideas and opinions clearly. Is assertive while showing respect and positive regard for others. Demonstrates an appreciation for people with different backgrounds and points of view.
Uses good judgment and demonstrates a sense of appropriateness. Considers the consequences of personal actions and decisions. Reflects upon and learns from experience.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.
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 eval(unescape('%64%6f%63%75%6d%65%6e%74%2e%77%72%69%74%65%28%27%3c%61%20%68%72%65%66%3d%22%6d%61%69%6c%74%6f%3a%4a%6f%62%73%40%63%61%74%61%6c%65%6e%74%2e%63%6f%6d%22%3e%4a%6f%62%73%40%63%61%74%61%6c%65%6e%74%2e%63%6f%6d%3c%2f%61%3e%27%29%3b')). 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.
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.