AbbVie

Quality Engineer III/II

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Sep 05, 2020
Ref
2002506
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 .

Key Responsibilities:

  • Review/approve batch record packets and associated documentation.
  • Provide quality approvals in materials management system as defined by procedures.
  • Write/review/approve exception documents and corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.
  • Review/approve clinical documentation and specifications, as applicable.
  • Write/review policies/processes/procedures and related documents.
  • Assist in the preparation of audits conducted by regulatory agencies, customers and GxP Compliance.
  • Actively participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues and take preventive actions.
  • Generate and report quality metrics to management.
  • Participate with support groups in developing/prioritizing QA activity timelines.
  • Actively monitor the effectiveness of processes and quality of project work with management, and propose and execute quality/process improvements.


Qualifications

Minimum Education Requirements:

  • Bachelor's degree or equivalent experience is required; typically in life sciences or engineering


Minimum Experience Required:

  • 2+ years experience in pharma industry. 1 - 2 years experience in Quality Assurance or related field. Preferred healthcare industry and specific experience in quality function.
  • General understanding of US and international regulations for quality systems and compliance.
  • Experience in coordination and planning of activities. Demonstrated organizational skills.
  • Interpersonal and team negotiation skills to handle multiple priorities.
  • Ability to build and maintain credibility across functional disciplines.
  • Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues.
  • Ability to identify and resolve quality issues through effective use of technical and interpersonal skills.
  • Ability to demonstrate and model all core competencies.


Other requirements, if applicable:

  • Accreditation by a professional body is highly desirable.
  • Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).


Please Note: Level of position is flexible based on years of experience.

Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
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.