Helpmates

Elevate Your Career as a Sr. Quality Assurance Specialist/Supplier Audit — Urgently Hiring Sr. Quality Assurance Specialist in Costa Mesa!

Job Title: Sr. Quality Assurance Specialist/Supplier Audit

Pay: $80,000 - $90,000 per year Hours: Full-time Start Date: ASAP

Looking for a career growth opportunity in quality assurance? Join a trusted leader in supplier audit and compliance as a Sr. Quality Assurance Specialist in Costa Mesa, CA, and make an impact every day. As a Sr. Quality Assurance Specialist, you’ll ensure the highest quality standards across our supply chain while fostering collaborative partnerships with suppliers. You’ll work closely with cross-functional teams to maintain compliance and improve quality outcomes.

What You’ll Do:

As a Sr. Quality Assurance Specialist/Supplier Audit, you will be responsible for:

• Planning and conducting detailed internal company and supplier audits to assess compliance with regulatory requirements.
• Generating and reviewing supplier quality agreements to ensure alignment with quality standards.
• Coordinating with third-party audit providers for international supplier assessments as necessary.
• Overseeing vendor qualification programs, including maintaining approved supplier documentation in the quality management system.
• Managing corrective action request programs to address findings from supplier audits.
• Maintaining comprehensive documentation related to audits, suppliers, and compliance activities.
• Evaluating audit findings, assessing risk levels, and monitoring the implementation of corrective and preventive actions.
• Participating in audit reporting and presenting key metrics to quality leadership.
• Collaborating across departments to support quality and compliance functions throughout the organization.
• Assisting in preparation for regulatory inspections and enhancing internal readiness initiatives.
• Facilitating the implementation of corrective and preventive actions (CAPAs) in partnership with cross-departmental teams.
• Reviewing laboratory data for accuracy, compliance with internal procedures, and regulatory standards.
• Authoring, reviewing, and approving standard operating procedures (SOPs) in accordance with quality standards.

What You’ll Bring:

The ideal candidate for this role will have:

• 8+ years of relevant work experience in quality management, with a focus on supplier quality in a pharmaceutical manufacturing environment.
• Minimum 5 years of direct Supplier Quality experience and leadership experience.
• 5+ years of experience conducting internal audits.
• Quality Auditor Certification (e.g., ASQ, CQE) preferred.
• Exceptional proficiency in Microsoft Office Suite, particularly in Excel and PowerPoint.
• A Bachelor's degree in chemistry, biochemistry, or a related field.

Why Join Us in Costa Mesa?

• Flexible hours that support your work-life balance.
• Career growth opportunities within a leading organization.
• Competitive pay and comprehensive benefits package.
• Enjoy affordable health and prescription coverage with no waiting period.
• Robust retirement plan options, including 401k/Pension.

Location & Schedule:

This position is on-site in Costa Mesa, CA, and offers a full-time schedule.

Ready to Take the Next Step?

If you’re ready to advance your career as a Sr. Quality Assurance Specialist in Costa Mesa, apply today or contact our recruiting team to learn more. Don’t wait, we’re hiring now!