Quality Assurance Specialist III

Published: 6/14/2022

Technology

Job Description

We’re partnering with a contract testing laboratory in Irvine, CA, to find an experienced Quality Assurance (QA) Specialist III who thrives on solving complex quality challenges, leading client audits, and ensuring regulatory inspection readiness.

In this high-impact role, you’ll serve as a key quality leader, working closely with clients and laboratory teams to oversee complex investigations, strengthen quality systems, and drive continuous improvement. If you have a strong background in GMP laboratory quality and enjoy taking ownership of critical compliance initiatives, this is an exciting opportunity to put your expertise to work!

The Quality Assurance (QA) Specialist III will:

Lead Client Audits: Serve as the primary host for client qualification, surveillance, and for-cause audits, including opening and closing meetings, audit discussions, and response preparation.
Drive Inspection Readiness: Coordinate FDA inspection readiness activities, conduct mock inspections, track remediation efforts, and monitor readiness metrics.
Oversee Complex Investigations: Lead reviews of out-of-specification (OOS) and out-of-trend (OOT) investigations, data integrity issues, and method-related deviations.
Strengthen Quality Systems: Provide technical leadership across laboratory quality systems and drive continuous improvement initiatives.
Protect Data Integrity: Provide QA oversight of laboratory computerized systems, including LIMS, chromatography data systems, electronic records, and audit trail review programs.
Evaluate CAPAs: Assess root cause analyses and corrective and preventive action (CAPA) effectiveness to support sustainable compliance.
Mentor and Develop Others: Guide junior QA Specialists, provide GMP and audit-hosting training, and support laboratory employee onboarding.
Manage Supplier Quality: Oversee supplier qualification and requalification activities, quality agreements, and related documentation.
Lead Internal Audits: Manage and standardize internal audit activities while identifying opportunities to improve compliance and efficiency.
Provide Quality Leadership: Serve as a primary quality contact for clients and step in as the acting quality lead in the absence of QA management.

Requirements:

Education and Experience:
- Master's degree in Biosciences, Regulatory Affairs, or a related field, with 5+ years of GMP laboratory quality experience; OR
- Bachelor's degree in a scientific or regulatory-related discipline, with 8+ years of GMP laboratory quality experience.
Demonstrated experience hosting and leading client audits.
Advanced knowledge of cGMP regulations and applicable FDA and ICH guidelines.
Strong understanding of 21 CFR Part 211, FDA Data Integrity Guidance, USP General Chapters, and OOS guidance.
Experience with laboratory computerized systems, data integrity, and analytical method lifecycle concepts.
Proven ability to evaluate complex investigations, root cause analyses, and CAPA effectiveness.
Strong communication, organizational, and problem-solving skills, with the ability to collaborate across teams and lead by example.
A commitment to accountability, ethics, integrity, and continuous improvement.

Why Consider This Opportunity?

Competitive Pay: Earn $43–$55 per hour.
Meaningful Impact: Play a key role in laboratory quality, client confidence, and regulatory compliance.
Technical Leadership: Take ownership of critical quality initiatives and mentor developing QA professionals.
Variety and Challenge: Work across audits, investigations, computerized systems, and quality improvement initiatives.
Potential for Long-Term Growth: Begin with a 6-month contract, with the possibility of transitioning to a temp-to-hire opportunity.

Ready to Make an Impact?

If you're an experienced GMP quality professional ready to lead audits, strengthen compliance, and help maintain the highest standards in a contract testing laboratory, we'd love to connect with you!