Software Quality Assurance
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 an IT Compliance Consultant based in North Chicago, IL., reporting to the Senior Software Quality Assurance Manager. Key responsibilities include:
oAuthor, review/audit, and approve project documentation associated with the SLC to support applicable federal and regulatory requirements oReview/approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate oEnsure recommended changes/improvements to support the Enterprise Systems are compliant to the internal and external policies, processes, and procedures oEstablish quality system requirements for the Information Enterprise Systems oProvides project quality leadership for validation or SLC activities oCreate and apply risk-based approach strategies effectively and efficiently without compromising compliance oApprove key project deliverables oServes as expert resource with regards to the Enterprise Systems and compliance issues oGenerate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc oLead process improvement projects
Qualifications:
4 year college degree (preferably BS) in Computer Science, Engineering, Chemistry, Pharmacy, Biology, or Microbiology Minimum of 4 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation, or compliance. Preferred:
2 years SAP Experience Key AbbVie Competencies:
oExperience with GxP regulations, internal policy/procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11) oBuilds strong relationships with peers and cross functionally and with partners outside of the team. oLearns fast, grasps the essence and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo. oCreates a learning environment, open to suggestions and experimentation for improvement. oEmbraces 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Software Development, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
oAuthor, review/audit, and approve project documentation associated with the SLC to support applicable federal and regulatory requirements oReview/approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate oEnsure recommended changes/improvements to support the Enterprise Systems are compliant to the internal and external policies, processes, and procedures oEstablish quality system requirements for the Information Enterprise Systems oProvides project quality leadership for validation or SLC activities oCreate and apply risk-based approach strategies effectively and efficiently without compromising compliance oApprove key project deliverables oServes as expert resource with regards to the Enterprise Systems and compliance issues oGenerate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc oLead process improvement projects
Qualifications:
4 year college degree (preferably BS) in Computer Science, Engineering, Chemistry, Pharmacy, Biology, or Microbiology Minimum of 4 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation, or compliance. Preferred:
2 years SAP Experience Key AbbVie Competencies:
oExperience with GxP regulations, internal policy/procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11) oBuilds strong relationships with peers and cross functionally and with partners outside of the team. oLearns fast, grasps the essence and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo. oCreates a learning environment, open to suggestions and experimentation for improvement. oEmbraces 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Software Development, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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