GXP QC IT Applications Analyst

Katalyst CRO; Lexington (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

The QC IT Application Analyst at Katalyst CRO collaborates with business and IT teams to provide compliance-focused support for GMP environments, including validation activities, incident triage, and system upgrades.

You will manage SDLC documentation (URS, IQ/OQ/ATRs), perform design testing, and oversee vendor-provided solutions while ensuring data integrity and regulatory compliance across Quality and Manufacturing systems.

Qualifications

• More than 5 years relevant IT/business experience, analysis, and documentation.
• Experience with software application implementations in GxP environment (required).
• Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration.
• Experience in the Pharmaceuticals or Life Sciences industry (preferred).
• Experience consulting or working in a complex, global matrix organization (preferred).
• Knowledge of Lean operational techniques (preferred).

Responsibilities

• Project upgrades from Windows 7 to Windows 10.
• Provide oversight of vendor-provided solutions.
• Handle ad-hoc technical requests from internal and external partners.
• Work with Direct team members for decisions and clarifications as needed.
• Must juggle multiple projects and deliverables across projects.

Skills

GxP IT systems support

CSV, 21 CFR Part 11

ITIL processes (ServiceNow)

Vendor oversight

SDLC documentation

Backup and Restore testing

Cross-functional collaboration

Education

Bachelor's degree in IT/CS/Engineering

Tools

Empower

Chromeleon

SOLO VPE

Client Unicorn

Nova Bioprofile CDV

WinKQCL

LabX

TrackWise

Job description

The QC IT Application Analyst at Katalyst CRO collaborates with business and IT teams to provide compliance-focused support for GMP environments, including validation activities, incident triage, and system upgrades.

You will manage SDLC documentation (URS, IQ/OQ/ATRs), perform design testing, and oversee vendor-provided solutions while ensuring data integrity and regulatory compliance across Quality and Manufacturing systems.