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 IT, Quality Specialist 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 e.g. calibration, SOPs, VMPs etc.
- Participate on process improvement projects
- 4 year college degree (preferably BS) in Computer Science, Engineering, Chemistry, Pharmacy, Biology, or Microbiology.
- Minimum of 2 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.
This position is part of AbbVie’s Information Security & Risk Management (ISRM) team. We are here to put our partners in a position to succeed. We do it by providing the knowledge, tools, and support they need to effectively use data and technology while also effectively managing risk.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced