Senior Software Quality Assurance Engineer

Employer
AbbVie
Location
Lake County, IL, US
Posted
Dec 04, 2018
Ref
1808809
Required Education
Bachelors Degree
Position Type
Full time
Software Quality Assurance ensures computer system software meets requirements and is validated throughout the system's and the drug development's life cycles. The functional group will ensure high quality products and data compliant with GxP regulations, internal policy/procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11). We have a challenging opportunity for a Software Quality Engineer based in North Chicago, IL., reporting to the Senior Software Quality Assurance Manager.

Key responsibilities include:

  • Author, review/audit, and approve project documentation associated with the SLC to support applicable federal and regulatory requirements
    • Review/approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate
  • Ensure recommended changes/improvements to support the Enterprise Systems are compliant to the internal and external policies, processes and procedures
  • Establish quality system requirements for the Enterprise Systems
  • Provides project quality leadership for validation or SLC activities
  • Create and apply risk-based approach strategies effectively and efficiently without compromising compliance
  • Approve key project deliverables
  • Serves as expert resource with regards to the Enterprise Systems and compliance issues
  • Generate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc
  • Participate on process improvement projects


Basic:

  • 4 year college degree (preferably BS) in Computer Science, Engineering, Chemistry, Pharmacy, Biology, or Microbiology.

Preferred:

  • Minimum of 4 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.

Key AbbVie Competencies:

  • Builds strong relationships with peers and cross functionally and with partners outside of the team.
  • Learns fast, grasps the "essence" and can change 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.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled