
CAPA Exception Document Specialist
Performs and documents GMP root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for R&D clinical drug product manufacturing and packaging. Develops, documents and tracks to completion corrective and preventive actions (CAPA) to prevent nonconformities from occurring again. Performs other compliance related tasks to support the business, such as authoring change requests to operating procedures, providing support for internal and customer audits and reviewing logbooks, batch records, etc. for accuracy and completeness. Holds regular CRB and IRB meetings and monitors tasks to ensure timely completion. Responsible for consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements.
Knowledge with statistics/forecasting software is a plus
7 years GMP experience is required
Time Management
Document processing and filing
Technical documentation skills
Investigation drafting skills
Self directed
Multifaceted
Communication Skills
Adaptability and Creativity
Process and Performance Improvement
According to JobzMall, the average salary range for a CAPA Exception Document Specialist in 1401 Sheridan Rd, North Chicago, IL 60064, USA is $69,600 - $90,000 per year.
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AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories.

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