Senior Specialist Quality Assurance
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 Senior Specialist Quality Assurance serves as a key team member with deep knowledge in Bioanalytical Quality Assurance methodologies. Provides daily oversight of laboratory testing operations, ensuring efficient workflow and adherence to quality standards. Identifies issues and implements solutions to keep testing activities on track. Demonstrates strong ownership of projects and fosters a culture of innovation and operational excellence within a regulated testing environment. Skilled in managing specialized initiatives, with proven leadership, problem-solving, collaboration, time management, and communication abilities. Effectively balances multiple competing priorities while contributing to strategic site initiatives and ensuring high-quality, compliant testing outcomes.
What You’ll Work On
Responsible for implementing and maintaining the effectiveness of the Quality system.
Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
Lead projects with cross-functional or broader scope. Interacts effectively with employees, manager, and cross-functional peers. Effectively represent own team while on cross-functional project teams with other functional leaders.
Strong foundational knowledge in broad range of bioanalytical techniques. Proven ability to guide and mentor laboratory teams. Proficient in laboratory investigations.
Lead and execute design planning activities for alternate reagent and material identification, evaluation, and implementation to ensure continuity of testing operations.
Collaborate cross-functionally to support product lifecycle management and ensure availability of critical testing materials. Communicates confidently and effectively with management, peers, and key stakeholders.
Author and review technical rationales, support investigations, and ensure compliance with regulatory and quality standards.
Lead smooth implementation and validation of new analytical technologies and test methods in the testing lab.
Proactively identify and implement cost-saving opportunities.
Drive continuous improvement and process optimization.
Responsible for application of quality principles and complex analysis of quality records, reports to form recommendations for improvements.
Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.
Ensures compliant documentation in area of responsibility.
While recognizing project interdependencies and with minimal oversight, leads complex quality discussions across various departments.
Keep abreast of the standards that regulate our industry. Participate and take all trainings and reviews as required on ISOtrain Learning Management System. Comply with Abbott Quality System (QS) requirements.
Conduct business in a manner that will protect human health; safety and the environment by complying with all applicable EHS laws; as well at the Abbott Global and Technical standards. Participates in lab safety.
Required Qualifications
Bachelor’s degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Analytical Science) with at least 5 years of experience in Quality or a related field; or Master’s degree with 3 years of experience, or Ph.D. with 2 years of experience in related field.
Background in the healthcare industry with demonstrated experience in quality assurance functions.
Strong written and verbal communication skills and critical thinking.
Solid understanding of diagnostic product manufacturing and testing, including diagnostic methods and applications.
Proven expertise in troubleshooting, product and process improvement, QC release testing, change control, compliance, and audit readiness (internal and external).
Familiarity with performance metrics and their application in driving continuous improvement.
Preferred Qualifications
Proven experience in developing, troubleshooting, transferring, and validating complex analytical test methods, with successful implementation in a Quality Assurance laboratory setting.
Demonstrated ability to provide technical support during routine testing activities and contribute to product launch readiness.
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.
The base pay for this position is
$85,300.00 – $170,700.00In specific locations, the pay range may vary from the range posted.
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