AbbVie Quality Engineer III/II in North Chicago, Illinois
Quality Engineer III/II
USA, Illinois, Lake County
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.
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 and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Job Type: Experienced
Job Level Code: IC