GxP QC Systems Analyst – CSV (Onsite)

Quantive Intelligence; Lexington (MA); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Quantive Intelligence is seeking a QC Laboratory Systems Analyst to support GMP/CSV environments in Lexington, MA onsite. The role focuses on validation testing, backup and restore activities, user access reviews, and audit trail reviews within a 100% on-site setup.

The candidate will collaborate with QA, Validation and Product Development teams, manage upgrades and vendor-provided solutions, and handle ad-hoc IT requests while maintaining SDLC documentation and GxP lab equipment compliance.

Formación

• More than 5 years relevant IT/business experience, analysis, and documentation of business and technical requirements (required)
• 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 Pharmaceuticals or Life Sciences industry (preferred)
• Experience consulting or working in a complex, global matrix organization (preferred)
• Knowledge of Lean operational techniques (preferred)

Responsabilidades

• Collaborate with the business and IT teams to support MA Biologics Operations Site Functions—Quality, Validation and Product Development.
• Manage work with limited oversight and multi-project delivery.
• Perform design testing of applications to support SDLC documents (URS, FRA, IQ/OQ, DFs, etc.).
• Oversee upgrades (e.g., Windows 7 to Windows 10) and vendor-provided solutions.
• Handle ad-hoc technical requests from internal and external partners.
• Ensure GxP lab equipment compliance and data integrity.

Conocimientos

GxP experience

CSV compliance

ITIL processes

Documentation SDLC

Vendor coordination

Educación

Bachelor's degree in IT/CS/Engineering or Business Administration

Herramientas

ServiceNow

TrackWise

Veeva

Descripción del empleo

Quantive Intelligence is seeking a QC Laboratory Systems Analyst to support GMP/CSV environments in Lexington, MA onsite. The role focuses on validation testing, backup and restore activities, user access reviews, and audit trail reviews within a 100% on-site setup.

The candidate will collaborate with QA, Validation and Product Development teams, manage upgrades and vendor-provided solutions, and handle ad-hoc IT requests while maintaining SDLC documentation and GxP lab equipment compliance.