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:
Corrective Action Preventive Action (CAPA) Specialist - Operations
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:
- Production areas that are clean, well-lit and temperature-controlled
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plan
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
- Vacation – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
- Retiree Healthcare program
- Robust 401(k) retirement savings with a generous company match
- 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 stable company with a record of strong financial performance and history of being actively involved in local communities
- 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
This position works out of our Tipp City, OH location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.
Tipp City, Ohio, is one of Abbott’s newest nutrition manufacturing facilities with technology that enhances production efficiency and product quality. Join us and you’ll be part of a family that’s dedicated to innovation and excellence and dedicated to nourishing millions of families around the world.
What You'll Work On
- Implement and maintain the effectiveness of the quality system
- Maintain the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the manufacturing operations area
- Progresses investigations through the CAPA system
- Work closely with other functional areas with the use of investigational tools to determine the root cause of any nonconformity, ensures that CAPA plans address root causes, and ensures that corrective actions and preventative actions are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems
- Work to ensure that actions are on time, thorough, complete, meet the needs of the business and customers and that required standards and/or procedural requirements are met
- Be an effective member of a multifunctional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct.
- Evaluate and progresses the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations, as output from ADC’s Quality System
- Facilitate the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
- Maintain the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
- Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
- Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
- Supports other organizations in the management of their CAPA actions and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner; and that viable corrective actions are identified and implemented to address any non-conformances.
You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.
Required Qualifications
- Associates degree in relevant field OR high school diploma/GED with 2+ years experience in a high volume, regulated manufacturing environment
- Able to apply strategic and quality logic and project management skills to investigation activities
- Good project management skills to deliver an effective service in a timely manner
- Attention to detail to ensure accuracy of work that forms part of the Quality System documentation
- Good written and oral communication skills to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization
- Able to work independently
Preferred Qualifications
- Bachelor’s degree in relevant field
- Experience in leading CAPA investigations
- Experience with ABTRAQ or other quality management system
- Project management experience
- Extensive root cause analysis experience
- Knowledge of FDA Quality System Regulations
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Pre-Employment Inquiries and Citizenship | U.S. Equal Employment Opportunity Commission (eeoc.gov)
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 and Military/Veteran friendly 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
$48,000.00 – $96,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ANSC Nutrition Supply Chain
LOCATION:
United States > Tipp City : Main/Liquid Plant
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Yes
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis, Wear ear plugs, Work at heights, e.g. ladders, scaffolds, catwalks, etc., Work in noisy environment, Work requiring repeated bending, stooping, squatting or kneeling
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