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Labeling Project Coordinator - III

Contract

Foster City, CA

Posted on Jan 11, 2018

Description:
Essential Functions
• Responsible for the coordination of new labeling implementation with Materials Management and Supply Chain Planners at multiple packaging sites worldwide.
• Allocates workload to ensure availability of required artwork for the full product range in compliance with new product approvals and existing product variation approval deadlines.
• Liaises with International and local Regulatory colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met. .
• Contributes to the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience.
• Manages complex workflows in an electronic labeling management system.
• Recommends improvements and develops systems/policies to enhance labeling operations.
• Authors standard operating procedures, guidelines and work instructions.
• Collaborates with team members to meet departmental goals and objectives.

Knowledge, Experience and Skills
• Highly capable at directing and coordinating project work.
• Strong verbal, technical writing and interpersonal skills.
• Proficient in Microsoft Office applications.
• Knowledge of FDA and cGMP standards as well as regulatory guidance documents.
• Prior experience in pharmaceutical or other regulated industry is preferred.
• Familiarity with artwork production and graphic design software a bonus.
• 6+ years of relevant experience and a BS or BA.
• 4+ years of relevant experience and a MS.
Onsite Offsite: Onsite Offsite Onsite


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GDH Consulting, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran’s status or any other category protected by law. In addition to federal law requirements, GDH Consulting, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities and/or employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, benefits and training.