Labeling Specialist I

Abbott • Plymouth, MN

4d • $50,700 - $101,300 • Onsite

About The Position

This position works out of our Plymouth, MN Site in the Structural Heart Division and works business hours Monday-Friday. The main purpose of the role is to be responsible for overseeing and managing the change control packages for product labeling and for ensuring that documentation is appropriate, justified and approved by responsible functional areas according to established procedures. Also responsible for proofreading resulting labeling copy at various stages and for the development and maintenance of labeling related specifications and documentation associated with these specifications. Additional responsibilities may include participation with new product teams plus successful completion of assigned projects.

Requirements

• Bachelors Degree in Science, English, Business or related field to ensure accuracy of highly technical information used by manufacturing operations and regulated by the FDA.
• A minimum of one to two years experience in a technical/quality or operational area.
• Must have the ability to problem solve, manage projects, influence internal and external groups and provide leadership.
• Must have organizational and human relations skills to deal with various levels of individuals and functional areas within the division.

Nice To Haves

• Previous experience working within a change control systems.

Responsibilities

• Edits, reviews, proofreads and approves labeling change control documentation and associated specifications such as OP, MS, PBOM, PMS, etc.
• Reviews labeling for consistency with similar or related products specifications.
• Communicates and coordinates labeling and documentation approvals with other sites.
• Must be able to rearrange priorities on short notice to react to customer needs.
• Labeling and documentation for new products or revisions must be completed accurately and on time.
• Documentation associated with the labeling change control process must meet Quality, Regulatory and GMP requirements, as they are official records for audits and legal actions.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level