IT Assurance Analyst, QMS Applications

This is a fully remote position, open to applicants in Texas.

📋 Description

• The IT Assurance Analyst delivers CSV/Assurance support for newly installed, upgraded, or modified computerized systems, networks, and software that facilitate cGMP functions in Manufacturing, Supply Chain, and Quality as part of the IT Quality and Compliance organizations.

• This position collaborates closely with Change Owners to create and uphold validation/assurance testing (IQ, OQ, IOQ, PQ, etc.) that align with Plant and Corporate policies and procedures.

• Accountable for reviewing, executing, documenting, and approving assurance testing/validation deliverables, while also coordinating other resources as needed for validation documents and activities.

⛳️ Requirements

• Proficient knowledge of Oracle Agile PLM and Oracle EBS is required.

• Familiarity with data migration and sampling methods is preferred.

• Training in process improvement is preferred.

• Resourcefulness and strong problem-solving abilities are essential, with a capability to identify inefficiencies and ambiguities, eliminate barriers, and achieve results through innovative, proactive planning.

• Experience in one of the following areas is mandatory: Quality, Manufacturing, Facilities/utilities, Pharma/Solution processes, Sterilization, IT Applications, and/or Control systems/software.

• Functional knowledge and experience with 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 is necessary.

• Strong organizational, presentation, meeting facilitation, and technical writing skills are required.

• Attention to detail and proficiency in proofreading and auditing validation documents are essential.

• Familiarity with automation tools is preferred.

🏝️ Benefits

• Candidates must be at least 18 years of age.

• A Bachelor's degree in Computer Science, Information Systems, Engineering, or a related field from an accredited college or university is mandatory.

• Experience in ERP systems development, change, implementation, and lifecycle management, with a preference for Oracle EBS and Agile applications.

• A minimum of 4 years of experience in Computer System Validation/testing in one of the following areas: Manufacturing, Lab/Facilities, Pharma/Solution processes, Sterilization, or Control systems.

• Familiarity with regulatory requirements pertaining to 21 CFRs - Part 11, 820, 210/211, EU Annex 11, and ERES/Data Integrity requirements.

• Experience with SOX, Data Privacy, and Security requirements is a plus.

• Ability to work collaboratively and communicate effectively with diverse key stakeholders (IT, Manufacturing, Quality, Supply Chain, Logistics, Finance, Internal Audit).

• Familiarity with Test Management tools (e.g., ValidationMaster), MS Excel, and/or SQL queries is preferred.

• Proven ability to thrive in a dynamic, demanding environment with minimal supervision while demonstrating high resourcefulness.

• Demonstrated experience in managing multiple priorities and delivering timely, high-quality results.