Senior Quality Control Engineer

Katalyst-Healthcares-; San Diego (CA); On-site; USD 150,000 - 185,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior professional to lead the implementation and integration of GMP QC systems in a regulated environment. You will coordinate system configuration, data migration, deployment, and stakeholder engagement across QA, IT, and vendors.

The role requires strong experience in QC/Lab systems validation, CSV/CSA, GAMP5, and DQ/IQ/OQ/PQ activities. You will drive kick-off sessions, manage risks, timelines, and ensure regulatory compliance throughout the

Qualifications

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

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 progress, risks, timelines, quality, and budget.

Skills

GxP knowledge

CSV compliance

Agile/Scrum

Stakeholder management

Documentation

Tools

LIMS

SDMS

Empower

SoftMax Pro

QuantStudio

LabX

Job description

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