Quality Control Analyst (Compliance & Quality)

Suvoda•Conshohocken, PA

About The Position

Suvoda is a global clinical trial technology company that develops digital experiences for clinical trial sponsors and sites. Its work supports complex, high-stakes clinical studies, including those in oncology, central nervous system, and rare disease. Employees working with clients, end users, or related systems are expected to understand the clinical trial industry, applicable regulations, Suvoda’s products and processes, and the specifics of each trial before taking actions that could alter system data. The Quality Control Analyst supports compliance and quality activities across software development and service delivery. The role reviews and approves software development life cycle (SDLC) and validation deliverables, identifies and reports issues before product release, and supports product and system releases through development phases. It also contributes to validation projects, vendor qualification, process improvement, quality documentation, and review of procedural deviations, with supervision or support where specified.

Requirements

1–3+ years of experience in a similar role.
Bachelor’s degree.
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.

Nice To Haves

Knowledge of GxP regulations, such as 21 CFR Part 312, Part 11, Annex 11, and ICH E6.

Responsibilities

Ensure activities and deliverables are completed in accordance with Suvoda procedures during the software development process, with little to no supervision or support from the Quality Control team.
Identify issues during product development or service delivery before release and ensure they are reported according to applicable procedures.
Release Suvoda products and systems through the various phases of development.
Review and approve SDLC and validation deliverables.
Work with delivery teams, system owners, and Compliance and Quality stakeholders on corrections and corrective actions when needed.
Perform in-process verifications in accordance with Suvoda procedures.
Participate in planning and execution of internal IT validation projects, including external-party software validation and migration projects.
Support onboarding and qualification of third-party vendors as necessary and in accordance with internal procedures.
Identify and participate in process improvement projects when required.
Act as a subject matter expert in areas of established expertise when required.
Author and review QMS documents when required, with Quality Control team supervision or support.
Review deviations from Suvoda procedures with Quality Control team supervision or support.