USA - Scientist

About the role

The Fountain Group is currently seeking a Quality Validation Associate for a prominent client located in Thousand Oaks, CA. This is a 100% onsite position with potential for conversion to full-time.

Responsibilities

• Provide QA oversight, review, and approval of validation deliverables and change controls within cross-functional project teams.
• Review validation documentation for accuracy, procedural compliance, GMP requirements, and regulatory expectations.
• Review and approve Validation Master Plans (VMPs), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Computer System Validation (CSV), and validation maintenance packages.
• Support validation activities for manufacturing facilities, utilities, equipment, processes, information systems, and computerized systems.
• Review system decommissioning documentation and ensure applicable QA requirements are addressed.
• Participate in project risk assessments and maintain requirements traceability throughout the project lifecycle.
• Support GMP-related quality issues and maintain project metrics, risk trends, and implementation-readiness reporting.

Requirements

• Bachelor's degree in Biotechnology, Microbiology, Pharmacy, or related discipline.
• Advanced degree may be considered in lieu of some experience requirements.

Skills

• Pharmaceutical/biopharmaceutical GMP validation
• Validation protocol writing and execution
• Validation documentation review and approval
• Validation Master Plans (VMP)
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Computer System Validation (CSV)
• Validation Maintenance
• Facilities, utilities, equipment, and process validation
• GMP regulations and compliance
• Change Control
• Risk Assessment
• Requirements Traceability
• Electronic Document Management Systems (EDMS)

Preferred Skills

• Veeva
• Kneat
• ALM
• Data Integrity
• Manufacturing systems validation
• Computerized systems validation
• Validation decommissioning
• Pharmaceutical or biopharmaceutical manufacturing experience
• Quality metrics and risk-trend analysis

Pay Rate: $66.67–$79.31/hr

Schedule: Monday–Friday, 8:00 AM–5:00 PM