Label System Specialist

Organization
Catalent Pharma Solutions
Job Location
Kansas City, MO
Job Description

Label Inspection, Dispensing, Label Design and Label Printing 

• Maintain, manage, request and create logbooks accurately for the purpose of inspecting, designing and printing labels in label control. 

• Documentation and paperwork management. Complete and understand all paperwork that is used for the creation, printing and inspection of labels. 

• Adhere to the master schedule and partner with QA to ensure that timeline is met. Communicate where needed. 

• Knowledge of label regulatory requirements and an understanding of where to verify answers. Comfortable interacting with client representatives. The knowledge to communicate suggestions while understanding their need. Educating others in an effective manner. 

• Project manager, client and team rapport. Ability to communicate, educate and assist in all areas of label control. 

• Subject Matter Expert for any and all issues related to label control. 

• Provide regulatory audit and client audit support. 

• Assist with enforcing the master schedule with a commitment to hitting OTD. Prioritize self with a big picture of the team. Promote team work where necessary to accomplish tasks. 
Clinicopia 

• Approve label designs in addition to Clinicopia verification and approval. 

• PS/PR verification for accuracy and required information including approvals. Have the ability to assist and educate as needed. 

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

• Create print requests per the master schedule. 

• Responsible for kit structure design, setting up model protocols, orderable kits, work orders and Val Pac in Clinicopia 4.2. 
General 

• Project manager, client and team rapport. Ability to communicate, educate and assist in all areas of label control. 

• Back up for daily Label Control Meeting and Operations Scheduling meeting . 

• Assist with enforcing the master schedule with a commitment to hitting OTD. Prioritize self with a big picture of the team. Promote team work where necessary to accomplish tasks. 

• Provide regulatory audit and client audit support.

Requirements: 

• A High-school Diploma or GED is required 

• Associates or Bachelor's Degree is preferred. 

• Demonstrated understanding/knowledge of production processes within the Clinical Trail Management (CTM) industry is preferred. 

• Some experience in Pharmaceutical or GMP regulated industry is preferred. 

• Must have excellent verbal & written communication skills and be proficient in preparing accurate, detailed documents. 

• Ability to train and assist with new processes. 

• Mid-level experience and proficiency in Microsoft Word & Microsoft Excel is required. 

• Previous working knowledge of Microsoft Windows (Outlook) or equivalent system is required. 

• Experience with label design software is preferred. 

• Experience with Clinicopia label design software is preferred. 

• Ability to learn in-house design software is required. 

• Knowledge of graphics software or CAD is preferred. 

• Must have the ability to read, analyze, and interpret SOP's and GMP's. 

• This position may require over-time. 

• On occasion, this position requires week-end overtime. 
• Time management, organizational and strong leadership skills are a must. 
• Ability to work as part of a team, ensuring commitments are met in a timely manner without hesitation to hold others accountable to their responsibilities. 
Knowledge/Skills Requirements: 
• 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. 
• Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification. Act ethically. 
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 
• Demonstrate a willingness to share skills and information with others. 
• Demonstrate a bias toward action. Get things done. Be willing to take a position, and assert influence to drive improvement. Foster teamwork to get results. 
• Demonstrated ability to read, write, and speak clear English. 
Physical Requirements: 
• Frequent sitting, standing, walking, climbing ladders/steps, reading of written documents and use of computer monitor screen, reaching with hands and arms, stooping, kneeling, crouching, talking, bending, grasping, listening. 
Business Environment: 
• Fast-paced 
• Customer-focused 
• Performance driven 
• Position will require access into all GMP areas including; Manufacturing, Primary Packaging, Secondary Packaging, storage areas, distribution, and highly active containment areas (potent drug facility) 
To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position. Catalent may assign reasonably related additional duties to individual employees, consistent with company policy. 
About Catalent 
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 [email protected]. 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.

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