Associate CAPA Specialist

Abbott Laboratories • Liberty, SC

229d • $50,000 - $100,000

About The Position

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. The main purpose of this role is to generate exception/CAPA documentation such as non-conformance reports and investigation reports required at the site for routine and non-routine manufacturing issues. The candidate will independently investigate all aspects of the exception event and determine the root cause, product impact, risk impact, corrections, and corrective/preventive actions. They will utilize device design history files, specifications, test methods, factory data, field data, or quality policies as necessary to support decisions. The role involves coordinating/facilitating meetings and/or communicating cross-functionally to develop solid solutions to CAPA activities, working 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. The candidate will concurrently manage multiple CAPA projects and tasks, ensuring timely completion, and track and trend CAPA related information to meet compliance requirements. They will be a key contributor of the CAPA team in identifying, developing, and implementing process or product improvements, and support the creation, implementation, and modification of product and process related documents including Operating Procedures and other related documents.

Requirements

• Bachelor's Degree in a related field or an equivalent combination of education and work experience.
• Minimum 2 years of CAPA work experience in a manufacturing plant environment.
• Minimum 2 years of experience in a regulated manufacturing environment.

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 collaboration with subject matter experts to develop robust CAPA solutions.
• Concurrently manage multiple CAPA projects and tasks, ensuring timely completion.
• Be a 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.

What This Job Offers

• Job Type: Full-time
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree