AbbVie

Quality System Liaison, R&D Quality Assurance

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Oct 01, 2020
Ref
2006118
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 .

Primarily responsible for managing the creation and revision of Quality System documents and processes including assessment of proposed changes taking all controlled documentation and processes into account. Furthermore, act as the interface between the RDQA QS Documentation Liaison group and supported R&D functions.

Responsibilities:
  • Provides client with understanding of the AbbVie Quality System and its practical application.
  • Participates in global compliance and continuous improvement projects related to Quality System documentation.
  • Ensures compliance during QS documentation creation and revision and is accountable for content design and logistics of multi- and cross-functional documentation review and approval.
  • Supports development of strategy for creation of complex QS procedural documents involving cross-functional teams.
  • Supports continuous improvement of Quality Documentation Standards
  • Provides training and assistance to R&D colleagues for documentation standards and documentation change control process when handling GxP documentation.


Qualifications
  • Bachelor's degree and 4+ years' experience in pharmaceutical industry (production and/or quality assurance) or related field OR completed technical / commercial education with 4 years related experience (OUS).
  • Basic understanding and knowledge of GxP requirements and pharmaceutical regulations.
  • Reliable and independent work style including systematic and organized work behavior
  • Strong oral and written communication and teamwork skills
  • Strong knowledge and experience with Microsoft Office products.
  • Strong analytical thinking and comprehension
  • Initial experience in procedural design and Document Management Systems
  • Good spoken and written English skills (OUS only)


Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.