GxP Quality Control Analyst | Validation & Compliance

Suvoda; Conshohocken (Montgomery County); On-site; USD 65,000 - 85,000; Full time

Job summary

Suvoda is a global clinical trial technology company shaping digital experiences for sponsor and site professionals in life-sustaining studies across oncology, CNS, and rare diseases.

The role focuses on ensuring QMS compliance, SDLC validation, and early issue detection during software development, with collaboration across Compliance, Quality, and Delivery teams to uphold regulatory standards.

Qualifications

• 1-3+ years of experience in a similar role.
• Bachelore2s degree required.
• Knowledge of GxP regulations (21 CFR Part 312, Part 11, Annex 11, ICH E6) preferred.
• High-achieving personality.
• Desire to learn and grow.
• Strong work ethic.
• Sense of ownership.
• Proactive attitude.
• Time management and organization skills.
• Attention to detail.
• Risk-based judgment.

Responsibilities

• Ensure activities and deliverables are performed during the software development process with little supervision by Quality Control.
• Identify issues during development and report per procedures.
• Release Suvoda products and systems through development phases.
• Review and approve SDLC and validation deliverables.
• Collaborate with Delivery and Compliance teams to perform corrections when needed.
• Perform in-process verifications per Suvoda procedures.
• Participate in internal IT validation projects and third-party software validation.
• Support onboarding/qualification of 3rd Party Vendors per internal procedures.
• Identify and participate in process improvements.
• Act as SME in areas of established expertise.
• Author/review QMS documents with supervision.
• Review deviations from procedures with supervision.

Skills

GxP knowledge

Attention to detail

Time management

Ownership

Proactive attitude

Strong work ethic

Risk-based judgment

Desire to learn

Education

Bachelore2s degree

Job description

Suvoda is a global clinical trial technology company shaping digital experiences for sponsor and site professionals in life-sustaining studies across oncology, CNS, and rare diseases.

The role focuses on ensuring QMS compliance, SDLC validation, and early issue detection during software development, with collaboration across Compliance, Quality, and Delivery teams to uphold regulatory standards.