Abbott Sr. QA Auditor in Princeton, New Jersey
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
The point-of-care (POC) testing industry is changing faster than ever. At Abbott Point of Care, we’ve stayed ahead of the curve. We are a worldwide leader in fundamentally changing healthcare delivery at the point of care with solutions that are intuitive, innovative, reliable, and cost-effective for our customers.
The Senior QA Auditor independently conducts assigned audits to assess compliance to applicable business/division requirements, external standards/regulations and Abbott Quality System requirements across multiple divisions or regions or has technical expertise.
Participate in audits of manufacturing, supplier/Third Party Manufacturers and, commercial affiliate sites.
Manages and or participates in initiatives/projects that are cross functional/ cross divisional in scope as Subject Matter Expert (e.g., due diligence, regulatory readiness, etc.)
Seen as a technical expert, or demonstrates ability to perform cross-division audits.
Ability to interpret and translate regulations into actions in a broad scope of activities across multiple divisions or regions.
THIS ROLE MAY BE FILLED AT 1 LEVEL LOWER DEPENDING ON INDIVIDUAL RELEVANT SKILLS AND EXPERIENCE
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
•Integrate regulatory, compliance, quality issues into audit and assesssment planning processes, based on risk.
•Ensures compliance to Regulatory, Division, Site and Corporate policies and procedures by promptly reporting non-compliance issues.
•Understand technical decisions that affect product quality.
•Provide expertise audit support to the division in preparation for and during external audits
•Identify and communicate compliance issues and risks promptly so that they are understood.
•Identify compliance risks against current standards/regulations and may guide in the planning and execution of Quality System improvements.
•Provide guidance and trains colleagues, provides oversight to one or more junior level auditors.
•May assume managerial experience.
•Utilizes expertise and audit intelligence during audits. Provides advice or recommendations for compliant and strategic solutions to complex quality issues.
•Understand the risk and benefits of findings on the division(s) through engagement with the businesses and/or regions.
•Demonstrates high proficiency in selected areas. For example: sterilization / aseptic processing, plastics and molding, IT and software quality assurance, good clinical practices.
•Maintains and demonstrates understanding of global standards, regulations and regulatory bodies.
•Development of management and supervisory skills through execution of managerial responsibilities as needed.
•The position has broad responsibility that has significant impact across the corporation.
•Excellent written and verbal communication skills. Personal skills needed, which include tact, open-mindedness, maturity, tenacity, decisiveness and sound judgment.
Bachelor / University / College degree or equivalent in a technical area. Bachelor's degree is highly preferred.
Background and experience:
Minimum eight (8) years. Related experience in the medical device / pharmaceutical industry / nutrition industry / related industry.
3 years minimum required auditing experience or equivalent.
Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; CFR 210/211, ISO 13485; IVDD; ISO 22000 etc.
Abbott Auditor Certification is a plus
APOC Point of Care
United States > Princeton : 400 College Road East
Yes, 25 % of the Time
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
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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