CAPA Specialist Columbus, OH Plant at Abbott Laboratories

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.

Nourish the world and your career as part of the Nutrition team at Abbott.

Abbott’s Nutrition Division 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 get the nutrients they need to live their healthiest life.

Columbus, Ohio, is Abbott’s first manufacturing facility in the world, making us a leader in science-backed nutrition products. Working here, you’ll be part of a family that works together to produce quality products that make a difference and help keep consumers nourished at every stage of their lives.

WHAT WE OFFER AT ABBOTT

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

• 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 plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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 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.
• A stable company with a record of strong financial performance and history of being actively involved in local communities.

WHAT YOU’LL WORK ON

MAIN PURPOSE OF ROLE

The CAPA Process Analyst I:

• Progresses investigations through the CAPA system in support of non-CAPA organizations.

• Works closely with other functional areas with the use of investigational tools, to determine the root cause of any nonconformity, ensure that CAPA plans address root causes, and ensure that CA/PAs are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems.

• Works 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.

• Is an effective member of a multifunctional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct.

MAIN RESPONSIBILITIES

• Evaluates and progress the timely completion of CAPA system activities, including effectiveness checks, raised for non[1]conformances, potential non-conformances, and/or deviations, as output from the division’s Quality System.

• Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.

• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.

• Ensure 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 the attainment of division goals and objectives.

• Accountable to the Quality Organization for achieving mutually agreed upon objectives.

• 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.

• The CAPA System is a key inspection focus of worldwide regulators and auditors.

• The system must be usable, simple, sustainable and well maintained.

• Failure to comply with the primary objectives of this role can result in negative impact to the business such as observations, warning letters, de-certification, or product recalls.

• Decisions and recommendations made by this position impact quality decisions for marketed products and the division’s

Quality System.

EDUCATION AND EXPERIENCE YOU’LL BRING

QUALIFICATIONS

• Associates Degree (± 13 years) or an equivalent combination of education and work experience: Bachelors Degree (± 16 years)
• Experience/Background: Minimum 2 years Minimum of two (2) years of experience working in a regulated environment or experience performing investigations.
• Knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 is preferred.
• Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted.
• 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.

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

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 and a 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 $57,300.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.