Specialist Quality Assurance

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:

THE OPPORTUNITY

This role will conduct quality-related activities in Complaint Handling to deliver consistent high-quality documents, services, products and processes, which adds value to the business. The primary function of the Quality Specialist is to assist in maintaining the quality system.

WHAT YOU WILL DO:

• 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, Metrics 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, ABTRAQ, SmartSolve, CMSNext/Salesforce, etc.
• Collect analysis and publish quality metrics.
• Provide data for support of budgetary submissions

EDUCATION AND EXPERIENCE, YOU’LL BRING:

REQUIRED:

• Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
• At least 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
• Direct experience in a Quality role in a GMP related industry
• Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.
• Demonstrates understanding of how their function supports the business.
• Demonstrates technical and business competencies that drive results and continuous improvement.
• Candidate should be flexible, have strong problem-solving skills, excellent written and oral communication skills, and be able to lead cross functional teams.
• Experience within quality assurance and complaint handling is preferred but not required. 

PREFERRED

• Experience in the Healthcare industry with history of completing successful projects and driving positive compliance outcomes
• Experience with technical problem prevention / resolution.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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

$66,700.00 – $133,300.00

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

     

JOB FAMILY:Operations Quality

     

DIVISION:AMD Molecular

        

LOCATION:United States > Des Plaines : DP01

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:Standard

     

TRAVEL:No

     

MEDICAL SURVEILLANCE:Not Applicable

     

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