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Abbott

Labeling Specialist II

Posted 18 Days Ago
Be an Early Applicant
California
80K-139K Annually
Mid level
California
80K-139K Annually
Mid level
The Labeling Specialist II supports large systems projects by managing data collection, ensuring compliance with UDI and FDA regulations, and facilitating communication across teams to meet project deadlines.
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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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Labeling Specialist II position works out of our Sylmar, CA location in the Cardiac Rhythm Management Division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.

Labeling Specialist II position provides support for large systems projects that require working with large amounts of data, ensuring data is
collected, accurate and complete for program.

 

MAIN RESPONSIBILITIES

What You'll Work On

 

This position:

  • Works across functional teams to collect, aggregate, match, consolidate, and confirm data and business elements as it is

    entered into the application.

  • Works across functional teams to ensure there is a consistent result for mined data.

  • Monitors to ensure data meets Unique Device Identifier (UDI), Labeling and FDA requirements for medical devices and follows the prescribed formats established in the regulations and internal work instructions.

  • Manages multiple concurrent deadlines.

  • Facilitates collection of data from various sources and functions and process of collating that data into a coherent

    collection.

  • Facilitates review and approval of the data, as required by each project.

  • Maintains knowledge of external requirements and new developments in database functionality and technologies.

  • Tracks, monitors and reports on changes to data elements. Provides training and user support.

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),

    Environmental Management Systems (EMS), and other regulatory requirements.

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies,

    operating procedures, processes, and task assignments.

  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors,

    and vendors.​

 

Required Qualifications

  • Bachelors Degree Related field OR an equivalent combination of education and work experience

  • Minimum 3 years

  • Proven ability to learn new software applications quickly.

  • Experience in Product Data Management (PDM), Manufacturing Execution System (MES),

  • Enterprise Resource Planning (ERP), or SAP systems preferred..

  • Prefer experience in Medical Device and/or a regulated environment.

  • Very strong MS Excel skills and experience with other MS Office Software (MS Word, PowerPoint, MS Project)

  • Exceptional organizational skills.

  • Ability to work in a highly matrixed and geographically diverse business environment.

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.

  • Strong organizational and follow-up skills, as well as attention to detail. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

  • Ability to travel approximately 5%, including internationally (only if required).

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

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/Abbottand on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

$79,500.00 – $138,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:Regulatory Operations

     

DIVISION:CRM Cardiac Rhythm Management

        

LOCATION:United States > Sylmar : 15900 Valley View Court

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:Standard

     

TRAVEL:Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing 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

Top Skills

Enterprise Resource Planning
Manufacturing Execution System
Excel
Ms Office (Word
PowerPoint
Product Data Management
Project)
SAP

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