The Fountain Group is currently seeking a Quality Validation Associate for a prominent client of ours. This position is located in Thousand Oaks, CA . Details for the position are as follows:
Job Title: Quality Validation Associate
Location: Thousand Oaks, CA – 100% Onsite
Pay Rate: $66.67–$79.31/hr
Duration: 6 Months / Potential Conversion to Full-Time
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Job Description
- 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.
Education
- Bachelor's degree in Biotechnology, Microbiology, Pharmacy, or related discipline.
- Advanced degree may be considered in lieu of some experience requirements.
Required 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
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