GMP Project Coordinator

Position Summary

• Provides organizational support to the Artwork and Labeling Development department by working directly with a cross functional team, external translation suppliers as well as internal Design Production Artist team to coordinate and execute activities related to the development of packaging and labeling items for the launch and maintenance of Diabetes Care products.

Main Responsibilities

• Responsible for coordinating with an internal cross functional team to develop packaging and labeling items for new products or revisions to existing products.
• Responsible for coordinating the efficient use of Department resources to meet deadlines for new product releases and revisions.
• Responsible for coordinating the translation of packaging and labeling items with language translation agencies.
• Responsible for interpreting project schedules and escalating project timeline risks and issues to management.
• Performs labeling coordination tasks using electronic workflow system and product lifecycle management system.
• Support assessment for projects to identify scope and impact to labeling.
• Issues Engineering Changes and modifies Bill of Materials in Agile for packaging and labeling components.

Knowledge and Skills

• Accuracy, attention to detail, and strong proofreading skills required.
• Ability to read and interpret project schedules.
• Must demonstrate strong problem solving techniques.
• Exhibits excellent verbal and written communication.
• Strong interpersonal skills, must be service oriented.
• Displays solid organizational skills, with the flexibility to quickly realign priorities to meet changing business needs.
• Ability to work on premises for core working hours of department.
• Excels in a fast paced, deadline-driven environment and is able to focus and follow guidelines with minimal supervision; ability to multi-task and anticipate resources necessary to complete the work.
• Experience with medical device labeling or labeling for highly regulated industry preferred.
• Experience in print production preferred.
• Ability to read and interpret project schedules.
• Demonstrates accountability, strong attention to detail and a commitment to accuracy-Strong proofreading ability and attention to detail is required.
• Must demonstrate strong problem solving techniques.
• Exhibits excellent verbal, written, and interpersonal communication skills when interacting with both internal and external customers
• Strong interpersonal skills, must be service oriented.
• Highly organized
• Knowledge in legal aspects of packaging, trademarks, and promotions is helpful but not a required.
• Background in print production is preferred but not required.
• Excels in a fast paced, deadline-driven environment and is able to focus and follow guidelines with minimal supervision; ability to multi-task and meet timeliness and accuracy standards by anticipating resources necessary to complete the work
• Prior experience in the pharmaceutical, healthcare, or medical device industry.
• Experience in a GMP environment, as well as familiarity with FDA and regulatory guidance documents related to Medical device labeling is preferred

Required Education and Experiences

• Bachelors Degree, preferably in Communications, Marketing, Business Administration, Academic or minimum of five years of relevant work experience in lieu of degree.
• 2-4 years of work experience including coordinating, organizing and executing project activities.
• Understanding of AGILE (or similar) documentation approval system.
• Familiar with Engineering Change Orders (ECs) and Bill of Materials (BOM).
• Familiarity with product lifecycle management system preferred.
• Computer literacy with PC. Proficient in Microsoft Office applications and Adobe Acrobat

Job Type: Full-time

Pay: $36.00 per hour

Schedule:

• 8 hour shift

Work Location: One location