Project Coordinator – Quality documentation

Location: San Mateo, CA
Job title: Project Coordinator – Quality documentation
Location: San Mateo, CA
Contract position

Job description
• Responsible for new labeling implementation working with Materials Management and Supply Chain Planners at multiple packaging sites worldwide.
• Coordinates 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.
• 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.
• Contributes to development of operational excellence projects.
Experience and Skills
• 6+ years of relevant experience 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 nice to have.
Warmest regards,
Aileen Bradley
Addastaff Consulting, Inc.
Senior Technical Recruiter
650-638-9633 x303

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