Specialist Quality Assurance

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 115,000 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.

·         Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

·         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

This position works out of our Alameda, CA location in the Abbott Diabetes Care.  We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. 

The primary function of the Quality Specialist is to assist in maintaining the quality system with responsibility for one or more of the following processes: batch release, complaint coordination, metric maintenance, surveillance program, testing program, document control, exception report and CAPA System and /or batch and sample retention and maintenance.

What You'll Work On

·  Assist with administration and ensuring compliance to Quality Management Systems including: Complaints Coordination, Batch Release, Exception Reports, CAPA, Document Control, Surveillance, Testing, Batch and Sample Retention and Maintenance, Metric etc.
·  Assist with other support duties as assigned.
·  Actively monitors Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations.
·  Reviews GMP related documentation for compliance such as batch records and associated data related to product manufacturing, testing and release, validation protocols and reports, labels, product specifications and other documentation as required.
·  Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required.
·  Maintains product complaint logs to identify and report recurring issues to quality assurance management and product development. Collaborate with other internal groups to respond to product inquiries and issues.
·  Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
·  Collaborates with members of the Quality Assurance team working on special projects.
·  Participate on permanent and temporary teams which are process or project driven.
·  Become familiar and subject matter expert on electronic support systems, TraqWise, GQMS, TeamCenter, compliance wire etc.
·  Collect analysis and publish quality metrics.
·  Provide data for support of budgetary submissions.
·  Be proficient with the complaint handling process and be able to review and assess customer complaints associated with division's products.
·  Review complaint communications and assess for compliance, reportability, and potential impact to patient safety and business operations.
·  Supports quality management by participating in other quality system processes, including audits, complaints, non-conformance and continuous improvement.
·  Has awareness for complaint process and understands and understands the quality consequences which may occur from the improper performance of their specific job.
·  Develops training material and delivers training to personnel.

Required Qualifications

·  Bachelor’s degree with minimum of 2 years’ experience with direct experience in a Quality or Regulatory Affairs role in a GMP related industry.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is
$65,900.00 – $131,900.00

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

United States > Alameda : 2801 Harbor Bay Parkway

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     
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