Associate CAPA Specialist Position Available In Pickens, South Carolina

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

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.

QUALIFICATIONS

Education Education Level :

Bachelors Degree (± 16 years)

Major/Field of Study :

Related field.

OR Education Level :

an equivalent combination of education and work experience

Experience/Background Experience :

Minimum 2 years

Experience Details :

– CAPA work experience in manufacturing plant environment. Minimum 2 years experience in regulated, manufacturing environment. The base pay for this position is $50,000.00 – $100,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Operations Quality

DIVISION

CRM Cardiac Rhythm Management

LOCATION

United States >

Liberty :

253 Financial Blvd.

ADDITIONAL LOCATIONS

WORK SHIFT:

Standard TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE

Yes

SIGNIFICANT WORK ACTIVITIES

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), Keyboard use (greater or equal to 50% of the workday) 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 Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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