American CyberSystems, Inc
Duluth, GA
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Job Description :
Project Coordinator

QUALIFICATIONS: The ideal candidate for this role has.

At least 5 years of experience as a Project Manager/Coordinator, with recent experience in a medical device labeling project preferred (or any type of medical device experience

A Bachelor’s Degree in a technical or engineering field, or equivalent.

Working knowledge FDA and cGMP standards as well as regulatory guidance documents

Consider it a coordinator role working with marketing and the regulatory team getting approvals, verifying content from the supervisor, providing staff to leaders in the organization (high accountability Negotiating but firm on deadlines and getting feedback from others. Tactful but direct.

ESSENTIALS: In this job you will. • Oversee and manage all aspects of labeling and packaging design projects. • Serve as the in-house expert and point-person for all labeling and documentation needs. • Create change control packages and assist in label content determination. • Generate and support the release of Engineering Change Orders (ECO) to implement new or revised labeling and procedures. • Establish and foster relationships with key project stakeholders from across the business unit. • Investigate and resolve Non-Conformance Reports (NCR) and Corrective and Preventative Actions (CAPA) related to labeling and documentation. • Ensure all standard operating procedures, regulatory and government requirements, and corporate policies related to labeling are adhered to in each project. • Facilitate project meetings with designers, engineers, and other technical specialists for design requirements, timelines, and project milestones.

SKILLS & ATTRIBUTES: The ideal candidate for this position must be. • A champion for logical, critical thinking. • A master at time management who is known for accurate time-tracking, completing “to-do” lists, and identifying and eliminating non-value-added tasks; supports and encourages team members in doing the same. • Comfortable being an “in-demand” person within the department and collaborating with diverse, multi-disciplinary teams to complete projects. • Able to manage, schedule, and adjust to competing priorities. • A highly skilled communicator, with an emphasis on good documentation practices and technical writing.
             

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