Associate CAPA 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:

MAIN PURPOSE OF ROLE:

Generate exception/CAPA documentation such as non- conformance reports and investigation reports required at the site for routine and non-routine manufacturing issues. Independently investigate all aspects of the exception event and determine the root cause, product impact, risk impact, corrections, and corrective/preventive actions. Utilize device design history files, specifications, test methods, factory data, field data, or quality policies as necessary to support decisions. Coordinate/facilitate meetings and/or communicate cross-functionally to develop solid solutions to CAPA activities. Work with Quality, Technical Operations, Manufacturing, Engineering, or purchasing as needed to recommend/document appropriate corrections, corrective/preventive actions based on facts obtained during base CAPA investigations. Concurrently manage multiple CAPA projects and tasks, ensuring timely completion. Track and trend CAPA related information, as appropriate, to meet compliance requirements. Be key contributor of CAPA team in identifying, developing, and implementing process or product improvements. Support the creation, implementation and modification of product and process related documents including Operating Procedures and other related documents.

MAIN RESPONSIBILITIES:

• Ensure that all CAPA documents are written in compliance to Division policy and site procedures.
• Document and investigate route and non-routine manufacturing issues independently or in collaborate with subject matter experts to develop robust CAPA solutions.
• Concurrently manage multiple CAPA projects and tasks, ensuring timely completion.
• Be key contributor to identifying and/or implementing CAPA process improvements.
• Accountable for strict compliance to cGMP as it relates to CAPA documentation accuracy, decision accuracy, process compliance, process efficiency, and timeliness.

The salary for this role is between:

N/A

JOB FAMILY:

Operations Quality

DIVISION:

ANSC Nutrition Supply Chain

LOCATION:

United States > Casa Grande : Plant

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

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)

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