Associate CAPA Specialist at Abbott

North Chicago, Illinois, United States

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Diagnostics, Medical Devices, Transfusion MedicineIndustries

Requirements

Bachelor’s degree in Life Science, or closely related discipline; Or an equivalent combination of education and work experience
Minimum 2 years' experience in quality or regulated manufacturing environment
(Preferred) CAPA experience

Responsibilities

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
Ensure that all CAPA documents are written in compliance to Division policy and site procedures
Document and investigate routine and non-routine manufacturing issues independently or in collaboration with subject matter experts to develop robust CAPA solutions
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

Skills

CAPA

Non-Conformance Reports

Investigation Reports

Quality Documentation

Exception Handling

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

Land your dream remote job 3x faster with AI

Try Jobo Free