Labeling Specialist I

Abbott; Plymouth (MA); On-site; USD 51,000 - 101,000; Full time

Benefits offered by this job

Tuition reimbursement

Free medical coverage

Retirement plan

Education benefit

Job summary

Abbott is seeking a Labeling Specialist I to oversee labeling change control packages, ensuring accuracy, justification and approvals across functional areas. You will proofread labeling copy and develop labeling specifications, contributing to multiple product lines within the Structural Heart division.

The role involves coordination with sites, managing priorities, and ensuring GMP-compliant documentation. Base pay ranges reflect Minneapolis-area levels and Abbott’s standards.

Qualifications

• Bachelor's Degree in Science, English, Business or related field.
• Preferred: experience with change control systems.
• Able to ensure accuracy of technical labeling and proofreading.

Responsibilities

• Edit, review, proofread and approve labeling change control documentation and specifications.
• Review labeling for consistency with related product specifications.
• Coordinate labeling approvals with other sites and stakeholders.
• Rearrange priorities on short notice to respond to customer needs.
• Ensure labeling documentation meets Quality, Regulatory and GMP requirements.

Skills

Labeling

proofreading

Change control

Documentation

Quality assurance

Education

Bachelor's degree in Science, English, Business or related field

Job description

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.

JOB DESCRIPTION:

Labeling Specialist I

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, 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... [ truncation removed for brevity ]。

Preferred Qualifications:

Previous experience working within a change control systems.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on X @AbbottNews.

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.

JOB FAMILY:

Operations Quality

DIVISION:

SH Structural Heart

LOCATION:

United States > Minnesota > Plymouth : 5050 Nathan Lane N

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf