Senior Quality Assurance Specialist

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:
Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
The position of Senior Quality Assurance Specialistis within our Toxicology Business Unit - Toxicology Laboratory located in Gretna, LA. The position will provide support in maintaining, improving, and ensuring compliance with specific elements of the quality system, including CAPA, Document Control, Audit Support, Training, Validation, and Complaints.
This job description will be reviewed periodically and is subject to change by management.
What You'll Work On

• Leading and/or contributing to system and process improvement projects
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Supporting equipment, process, and facility qualification, and validation activities
• Supporting external agency and internal audits as needed
• Aid in implementing process improvements concerning Quality Assurance processes.
• Maintain Quality metrics as required.
• Provide support (management/execution) with CAPA, change requests, deviations, and nonconformances.
• Manage training program.
• Manage complaints as required.
• Perform Document Control activities as required.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Understands and is aware of the quality consequences that may occur from the improper performance of their specific job.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation, and effectiveness of Quality Management Systems per laboratory regulatory agencies.
• Perform other duties and projects as assigned.

Required Qualifications

• BS/BA degree or equivalent in chemistry, biology, engineering, or other scientific discipline.
• Minimum of 5 years of Quality Assurance or Regulatory Compliance experience in a regulated laboratory or manufacturing environment, with preferably 3-5 years progressively responsible positions.
• Thorough knowledge and practical application of Quality System Regulations 21 CFR 820, ISO 13485, ISO 14971, and IVDD or SAMHSA/NLCP, CAP, CLIA, NY State or ISO 17025.

Preferred Qualifications

• Previous experience in a QA role in the IVD industry and/or DOA (Drugs of Abuse) industry is highly desirable.
• Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic, or SAMHSA / CAP / CLIA / NYS regulated laboratories.
• Knowledge of Quality System Regulations.
• Experience with MS Office.
• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
• Must be detail-orientated, self-motivated, and available for flexible scheduling.
• Strong communication, problem-solving and motivational skills.

* 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 Twitter @AbbottNews.
The base pay for this position is
$83,000.00 - $166,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
TOX ARDx Toxicology
LOCATION:
United States > Gretna : 1111 Newton Street
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
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