Senior Quality Control Engineer

Katalyst CRO; Frankford (DE); Vor Ort; USD 130.000 - 180.000; Vollzeit

Zusammenfassung

Katalyst CRO is seeking a seasoned professional to lead implementation and integration of GMP QC systems. You will coordinate configuration, data migration, deployment, and stakeholder engagement to ensure compliant, on-time delivery.

Responsibilities include kick-off sessions, progress monitoring, risk and budget management, and support for CSV/CSA validation activities. Collaboration with QA, IT, and vendors is essential to ensure regulatory compliance and release readiness.

Qualifikationen

• 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments.
• Experience with QC/Laboratory systems implementation and validation.
• Knowledge of CSV, CSA, GAMP5, and GxP regulations.

Aufgaben

• Lead implementation and integration activities for GMP QC systems.
• Coordinate system configuration, data migration, deployment, and stakeholder engagement.
• Conduct implementation kick-off sessions and drive project execution; monitor progress, risks, timelines, quality, and budget.
• Prepare status reports and ensure transparent progress tracking; support CSV/CSA and validation activities with IQ/OQ/PQ documentation.
• Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance and release readiness.

Kenntnisse

GxP compliance

Stakeholder management

Project coordination

Agile/Scrum

Regulatory compliance

IQ/OQ/PQ execution

Tools

LIMS

SDMS

Empower

SoftMax Pro

QuantStudio

LabX

Jobbeschreibung

• Lead implementation and integration activities for GMP QC systems.
• Coordinate system configuration, data migration, deployment, and stakeholder engagement.
• Conduct implementation kick-off sessions and drive project execution. Monitor project progress, risks, timelines, quality, and budget adherence.
• Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation. Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
• Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.

Roles & Responsibilities

• Lead implementation and integration activities for GMP QC systems.
• Coordinate system configuration, data migration, deployment, and stakeholder engagement.
• Conduct implementation kick-off sessions and drive project execution. Monitor project progress, risks, timelines, quality, and budget adherence.
• Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation. Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
• Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.

Requirements

• 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments. Strong experience with QC/Laboratory systems implementation and validation. Knowledge of Computer System Validation (CSV), CSA, GAMP5, and GxP regulations.Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities.
• Experience managing system integrations, data migration, and cross-functional project delivery.
• Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.Strong stakeholder management, Agile/Scrum, and project coordination skills.Excellent communication and documentation capabilities