Job Posting Title:QA Specialist III - QA Validation Requisition Number: 8176
Country: US
State: California
Job Location: Foster City
Functional Area: QA/QC
Position Type: Regular
Shift: Days
Specific Responsibilities:
This is an outstanding opportunity to join Gilead's evolving & progressive Quality Assurance organization.
Essential Duties and Job Functions:
- Provide QA support for Computer system validation, equipment qualification and apply risk based methodology to validation efforts
- Provide QA assessment and approval for GXP Computer system changes
- Review and revise SOPs for consistency and compliance with regulatory requirements
- Support the improvement and maintenance of Quality Systems
- Assist with the QA GMP Warehouse activities as necessary
- Support regulatory inspections by FDA and foreign regulatory agencies
Knowledge, Experience and Skills:
- Must have strong knowledge of cGMP (FDA, EU and ICH) requirements and the ability to assess compliance risks
- Experience with implementation/improvement of quality systems
- Experience implementing and maintaining GXP Computer systems in a validated state
- Experience providing QA oversight of facility changes and equipment qualification
- Excellent communication skills (both oral and written) including the ability to effectively communicate across organizational levels and functions
- Facilitate open communication and sharing of knowledge
Specific Education and Experience:
Typically requires a BA or BS degree and minimum 6 years of relevant experience in related field or a MA or MBA degree and minimum 4 years of relevant experience.
