Overview
Quality Assurance Specialist Jobs in Richmond, CA at Advantage Technical
Title: Quality Assurance Specialist
Company: Advantage Technical
Location: Richmond, CA
Quality System Specialist II
Location: Richmond, CA
Schedule: Onsite, Monday–Friday, 8:00 AM–5:00 PM
Duration: 6-Month Contract with opportunity to extend
Pay Rate: $40–$45/hour or up to $90,000 a year
- Must have Veeva experience
- Must be a US citizen, green card holder, or not require sponsorship now or in the future
Position Summary
The Quality System Specialist II supports Quality Operations by ensuring compliance with regulatory requirements, quality standards, and internal procedures within a regulated manufacturing environment. This role combines hands-on support on the manufacturing floor with quality system oversight to drive product quality, regulatory compliance, and continuous improvement initiatives.
Key Responsibilities
Quality Operations Support
- Participate in daily Tier 2 Gemba meetings and provide real-time quality support to manufacturing operations.
- Review batch records and perform product release activities to ensure compliance with established quality standards.
- Review and approve stability studies, labeling documentation, First Article Inspections (FAIs), field bulletins, and other quality-related records.
- Provide guidance and support regarding quality and regulatory requirements.
Quality Systems & Compliance
- Monitor and maintain training compliance across assigned areas.
- Chair Material Review Board (MRB) meetings and facilitate disposition activities.
- Participate in Environmental Control Meetings and support quality-related initiatives.
- Coordinate and manage Quality Notifications (QNs), nonconformances, deviations, and corrective actions.
- Support internal and external audits, ensuring audit readiness and timely responses to requests.
- Compile, analyze, and update quarterly quality metrics and reports.
Continuous Improvement & Risk Management
- Drive compliance and risk mitigation by ensuring products and processes meet regulatory and internal quality requirements.
- Support root cause investigations and continuous improvement activities to address quality issues and prevent recurrence.
- Review quality data, implement quality standards, and maintain documentation in accordance with Good Documentation Practices (GDP).
- Serve as a subject matter expert (SME) for assigned product lines and regulatory compliance requirements, including ISO 13485 standards.
Impact You'll Make
- Ensure compliance with FDA regulations, ISO standards, and internal quality system requirements.
- Improve product and process quality through effective review, investigation, and quality oversight.
- Support successful internal and external audits through strong documentation and audit readiness.
- Partner cross-functionally with Manufacturing, Engineering, Regulatory Affairs, and Operations teams to maintain product integrity and drive quality excellence.
- Contribute to strategic quality initiatives that enhance operational performance and reduce risk.
Qualifications
Required
- Associate degree in Biology, Chemistry, Life Sciences, or a related technical field, or equivalent combination of education and experience.
- Minimum of 2 years of experience in a regulated manufacturing environment.
- Working knowledge of GMPs and quality system standards, including ISO 13485, FDA 21 CFR Part 820, and/or 21 CFR Parts 210/211.
- Experience supporting medical device, pharmaceutical, biotechnology, or other regulated manufacturing processes.
- Experience with:
- Nonconformance investigations
- Deviation management
- Batch record review
- Product release activities
- Proficiency with Quality Management Systems (QMS), SAP, Veeva, and Microsoft Office applications.
- Strong organizational, communication, time management, and problem-solving skills.
- Ability to work independently while collaborating effectively across multiple departments.
Preferred
- Experience supporting audit readiness and regulatory inspections.
- Experience leading cross-functional quality meetings and quality improvement initiatives.
- Familiarity with quality metrics reporting and trend analysis.
