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Company Contact Info
- St. Louis, MO 63146
- Phone: 973-984-7900
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Townsend & Associates • St. Louis, MO
Posted 24 days ago
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W2 ONLY!! NO CORP TO CORP!!
Description: This Business Analyst, IT Systems and Compliance role will take direction from a Team Leader to support and enhance the quality and compliance operations posture for an IT department. Perform business analysis, compliance and computer system validation working between two company locations.
- Performing, reviewing and/or approving quality and compliance work activities and documentation related to IT change management, computer system validation, periodic activities and software development.
- Assist in integrating the IT department with both site manufacturing quality and global IT quality processes procedures as well as assist in continuous improvement projects for IT quality and compliance operations.
- Manage projects and compliance activities as assigned.
- Perform BT Quality Management activities related to qualification, GXP validation, and change-management of IT systems.
- Provide technical expertise to write computer system lifecycle, validation, and decommissioning documentation in accordance with cGxP, 21 CFR Part 11, 210, and 211, and other applicable regulations and procedures.
- Develop and manage project documentation for SDLC requirements during computer system implementation projects including developing user and functional requirements; technical and functional business process flows, use case, test case and test script documents; perform functionality, usability and testing during required project phases.
- Perform IT system periodic activities and oversee the process for completion according to quality procedures.
- Assist in performing impact assessments and work with technical SMEs to close-out IT related CAPAs and commitment tracking items.
- Represent company BT in site level change control meetings and act as main point of contact for company BT core solution teams regarding change management, quality assurance and compliance management.
- Work with Site Quality Organization and company BT Quality Assurance personnel staff to review, update and approve all documentation.
- Act in a project lead and/or business analyst capacity for assigned projects to include performing project documentation, tracking and communicating project status and status of deliverables, risk and issue analysis and problem resolution.
W2 ONLY!! NO CORP TO CORP!!
- Bachelor's degree in Computer Science, Information Technology or other science-related discipline.
- BA with CSV (computer systems validation) experience.
- At least 1 year of experience (ideally 3+ years) in current Good Manufacturing or Laboratory Practices, CFR 21 Part 11 regulations, Good Documentation Practices, and other applicable regulations for validated computerized systems.
- At least 1 year of experience (ideally 3+ years) in writing Validation Documents (e.g. Validation Master Plans, Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).
- Must have demonstrated capability in completing projects according to prescribed timelines and other requirements in previous project management or business analyst roles.
- Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project.
- Be able to function in multidisciplinary teams, must possess excellent documentation, presentation, training and computer skills.
Experience w/ Aseptic Techniques, Manufacturing, GMP and FDA.
- Experience with SDLC and other IT project management methodologies; Agile development is a plus.
- Lean Six Sigma certification and/or experience preferred.
- Familiarity with lab systems, plant manufacturing systems, Document Management Systems, CAPA processes, Learning Management Systems, highly desirable.