Job ID 9123
Career Level Executive
Experience 2 Years
Category / Function Management
Qualifications Degree Bachelor
IT QA Analyst II (Manual Testing)
Responsible for quality activities within the Information Technology (IT) department by supporting audits on behalf of IT; reviewing computer systems & processes for compliance with departmental Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) guidance and applicable regulations including FDA 21 CFR part 11; and facilitating IT responses to customer Requests for Information (RFIs)/Requests for Proposals (RFPs).
- Support the system and integration testing for new project implementations in addition to regression testing during ongoing system releases
- Contribute/draft the test plan for new projects
- Focused on continuous improvement of quality measures of existing system and integration landscape
- Supports the IT audit response across the IT departments in collaboration with IT Quality Assurance
- Consultant(s) and Corporate Quality Assurance (QA). Provides assistance in preparations for upcoming audits, including documentation assembly and review, and participates as required. Assists with identification of appropriate IT Subject Matter Experts and coordination of interviews with Corporate QA Audit Coordinators.
- Assists with compilation and distribution of IT departmental audit findings reports, and conducts follow-up activities to ensure timely closure of CAPAs and QIs.
- Conducts internal IT inspection readiness audits.
- Performs periodic review of IT Change Management tickets to ensure proper and timely completion and closure.
- Supports the IT Quality Assurance Consultant(s) with IT responses to RFP/ RFI. Assists with research and provides content for IT related subject matter. Manages the IT related RFP and RFI content for the information library by facilitating content with the IT Subject Matter Experts (SMEs), and performing period reviews and updates.
- Assists with the drafting and revisions of IT departmental SOPs with the appropriate departmental SOP authors and reviewers, and manages the SOP documents in alignment and collaborating with Corporate QA to ensure compliance with document controls, etc.
- Coordinates training on departmental SOPs. Ensures that IT departmental training records are current and that required employee training is up to date.