AbbVie

Quality Engineer I/Product Compliant Specialist

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Nov 13, 2020
Ref
2008397
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 .

The R&D GMP (Good Manufacturing Practice) Quality, Clinical Product Supplies, organization is responsible for Product Quality Assurance for investigational medicinal products (IMP), including both pharmaceutical drug and drug/device combination products. The Quality Engineer (QE) I/Product Compliant Specialist position supports Finished Dosage Forms manufactured and packaged at R&D facilities in Lake County (AP16/AP15), Ludwigshafen, and Third Party Manufacturers.

As dictated by the organizational needs, the key responsibilities may include:

General Activities:

  • Write/review policies/processes/procedures and related documents.
  • Lead/assist in the preparation and management of inspections/audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
  • Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues.
  • Generate, analyze and report quality metrics to management.
  • Lead/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.

Packaging/Labeling QA activities:
  • Review/approve batch record packets and associated documentation.
  • Provide quality approvals in the materials management system as defined by procedures.
  • Manufacturing Quality Assurance (MQA) line support providing real-time monitoring of manufacturing processes by conducting in-process quality inspections.
  • Write/review/approve exception documents and corrective actions/preventive actions (CA/PA) and product complaints and ensure they meet timeliness requirements.
  • Review/approve clinical documentation and specifications, as applicable.

Product Complaint Handling Activities:
  • Interface with external clinical investigators, drug depots/distributors, and partner companies to obtain product complaint information.
  • Review adverse events for potential related product complaints.
  • Initiate new product complaint records in the electronic system, determine investigation needs based on complaint details, drive investigation activities, and document the final report.
  • Collaborate with equivalent role in Ludwigshafen R&D QA to ensure consistency and adequate support for all R&D product complaints.
  • Work closely with manufacturing and quality engineer personnel to perform complaint investigations and CAPAs, as necessary.
  • Assess risk/impact of complaints to clinical supplies.
  • Liase with Post Marketing Quality to assess reportability of complaints received for marketed products used in clinical studies to regulatory agencies.
  • Liase with safety organizations to ensure consistency of information between related product complaints and adverse events.

Qualifications

Qualifications:

Basic:
  • Bachelor's degree or equivalent experience is required; typically in life sciences or engineering
  • A minimum of 4+ years experience in Quality Assurance or related field. Preferred healthcare industry and specific experience in quality function.
  • Strong understanding of US and international regulations for quality systems and compliance.
  • Experience in coordination and planning of complex activities. Demonstrated successful experience in Project Management and proven organizational skills.
  • Interpersonal, team, leadership, and negotiation skills to handle conflicting 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 complex problems through effective use of technical and interpersonal skills.
  • Ability to demonstrate and model all core competencies.

Key AbbVie Competencies:
  • Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
  • Learns fast, grasps the "essence" and can change the course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Significant Work Activities
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.