AbbVie

CAPA Exception Document Specialist

AbbVie

1401 Sheridan Rd, North Chicago, IL 60064, USA
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

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.

Where is this job?
This job is located at 1401 Sheridan Rd, North Chicago, IL 60064, USA
Job Qualifications
  • Knowledge with statistics/forecasting software is a plus

  • 7 years GMP experience is required

Required Skills
  • Time Management

  • Document processing and filing

  • Technical documentation skills

  • Investigation drafting skills

Soft Skills
  • Self directed

  • Multifaceted

  • Communication Skills

  • Adaptability and Creativity

  • Process and Performance Improvement

Compensation

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.

Additional Information
AbbVie is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedApril 17th, 2021
Apply BeforeJune 21st, 2025
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About AbbVie

AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories.

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