Labeling Specialist I

RXinsider LTD.; Plymouth, Northern (MN, KY); Hybrid; USD 51,000 - 101,000; Full time

Job summary

Abbott in Plymouth, MN is seeking a Labeling Specialist I to oversee change control documentation for product labeling, ensuring accuracy and compliance with GMP, QA and regulatory standards. You will coordinate with cross-functional teams, proofread labeling copy, and maintain labeling specifications, participating in new product teams and projects to support timely product introductions.

The role focuses on quality, documentation and timely delivery of labeling changes that impact product

Qualifications

• Bachelor’s degree required in science, English, business or related field.
• 1–2 years of experience in a technical/quality or operational area.
• Ability to problem solve, manage projects, influence groups, and provide leadership.
• Strong organizational and interpersonal skills to work across divisions.

Responsibilities

• Oversee and manage change control documentation for labeling and related specifications.
• Proofread labeling copy at various stages and develop labeling-related documentation.
• Coordinate with new product teams and participate in assigned projects.
• Review labeling for consistency with product specifications.
• Ensure documentation meets Quality, Regulatory and GMP requirements.

Skills

Problem solving

Project management

Leadership

Education

Bachelor's Degree in Science/English/Business or related field

Job description

Labeling Specialist I

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to :

• Career development with an international company where you can grow the career you dream of.
• 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.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

Divisional Information

Structural Heart Business Mission : Why We Exist! Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

The Opportunity

This position works out of our Plymouth, MN Site in the Structural Heart Division and works business hours Monday-Friday.

Main Purpose of the Role

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.

What You’ll Work On

• 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.
• Quality of the product is directly linked to the accuracy of the associated documentation.
• Not meeting the scheduling requirements will result in a delay in new product introduction which can have a far reaching affect on product sales and can further result in a delay in implementing design improvement which in turn can affect labor cost and product marketability.
• Failure to produce accurate copy can result in loss of printed supplies and potential product recall or field action.
• 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

Required Qualifications

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.

Preferred Qualifications

Previous experience working within a change control systems.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $50,700.00 – $101,300.00. In specific locations, the pay range may vary from the range posted.