IT Assurance Analyst, QMS Applications
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Job Description
IT Assurance Analyst providing CSV/Assurance support for cGMP functions in Manufacturing, Supply Chain, and Quality. Collaborates with Change Owners for validation testing compliance.
Responsibilities:
- The IT Assurance Analyst provides CSV/Assurance support for computerized systems, networks and software that have been newly installed, upgraded and/or modified to support cGMP functions in Manufacturing, Supply Chain, and Quality, as part of IT Quality and Compliance organizations.
- This role works closely with Change Owners to generate and support validation/assurance testing (IQ, OQ, IOQ, PQ etc.) that are compliant with Plant and Corporate policies and procedures.
- Responsible for reviewing, executing, documenting and approving assurance testing/validation deliverables, and if necessary, coordinate other resources in validation documents and activities.
Requirements:
- Working knowledge of Oracle Agile PLM and Oracle EBS required.
- Working knowledge of data migration and sampling methods preferred.
- Process improvement training preferred.
- Resourcefulness and problem‑solving skills, with the ability to navigate identify inefficiencies and ambiguity, remove obstacles, and deliver outcomes through innovative, forward‑thinking planning needed.
- Experience in one of the following disciplines required: Quality, Manufacturing, Facilities/utilities, Pharma/Solution processes, Sterilization, IT Applications and/or Controls systems/software.
- Experience and functional knowledge of Good Automated Manufacturing Practice (GAMP), cGMP, SDLC, Risk Assessment, EU Annex 11, ISO 13485 and/or 21 CFR Part 11 Electronic Records and Electronic Signatures needed.
- Good organizational, presentation, meeting facilitation, and technical writing skills required.
- Attention to details and the ability to proofread and audit validation documents required.
- Familiarity with automation tools preferred.
Benefits:
- Must be at least 18 years of age.
- Bachelor's degree in Computer Science, Information Systems, Engineering, or a related field from an accredited college or university is required.
- Experience in ERP systems development, change, implementation, and lifecycle management – preference to Oracle EBS and Agile applications.
- 4+ years of experience in Computer System Validation/ testing in one of the following – Manufacturing, Lab/Facilities, Pharma/Solution processes, Sterilization, Controls systems.
- Familiarity with regulatory requirements related to 21 CFRs - Part 11, 820, 210/211, EU Annex 11 and ERES/ Data Integrity requirements.
- Experience working with SOX, Data Privacy and Security requirements a plus.
- Ability to collaborate and communicate with a variety of key stakeholders (IT, Manufacturing, Quality, Supply Chain, Logistics, Finance, Internal Audit).
- Familiarity with Test Management tool (e.g., ValidationMaster), MS Excel and/or SQL queries preferred.
- Demonstrable experience of working well in a dynamic, demanding environment with minimal supervision and high resourcefulness.
- Demonstrable experience in balancing multiple priorities and delivering timely, high-quality outcomes.
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