GMP QC IT Applications Analyst: Validation & Support

United Pharma; Massachusetts; On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma is seeking a QC IT Application Analyst to support GMP-compliant operations, including validation activities, backup/restore testing, and audit trail reviews. You will collaborate with Quality, Validation and IT teams on QA systems and participate in SDLC documentation.

Responsibilities include front-line client support, handling ad-hoc IT requests, and oversight of vendor-provided solutions while ensuring data integrity and adherence to 21 CFR Part 11.

Qualifications

• Bachelor’s degree in Computer Science or Information Systems or related field if preferred.
• Experience with CSV, 21 CFR Part 11, and Data Integrity compliance.
• Familiarity with ITIL processes in ServiceNow (Incident, Change, Problem, CMDB).
• Knowledge of SDLC documentation such as URS, FRA, IQ, IQOQ, SOPs, and data flow diagrams.

Responsibilities

• The QC IT Application Analyst collaborates with the business and IT teams to provide project support for MA Biologics Operations Site Functions – Quality, Validation and Product Development.
• Project upgrades from Windows 7 to Windows 10; oversight of vendor-provided solutions; handle ad-hoc technical requests; coordinate repair activities when systems are down.
• Assist with design testing of applications and author SDLC documents; maintain documentation revisions and process improvement.

Job description

United Pharma is seeking a QC IT Application Analyst to support GMP-compliant operations, including validation activities, backup/restore testing, and audit trail reviews. You will collaborate with Quality, Validation and IT teams on QA systems and participate in SDLC documentation.

Responsibilities include front-line client support, handling ad-hoc IT requests, and oversight of vendor-provided solutions while ensuring data integrity and adherence to 21 CFR Part 11.