AbbVie

Senior CAPA Exception Document Specialist

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Nov 05, 2020
Ref
2007632
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Purpose:
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.

Responsibilities:
  • Extensive technical writing capability for exception document and investigation drafting
  • Responsible for consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements.
  • Coordinate the exception document process and write exception documents.
  • Ensure that all investigations are written according to corporate, division, and local requirements

Qualifications
  • Required: Bachelor's Degree or equivalent experience
  • Preferred: BS plus 7 years GMP experience or MS plus 5 years GMP experience

Significant Work Activities
N/A
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.