Quality Assurance Specialist III

Curia • Camarillo, CA

1d • Onsite

About The Position

The Quality Assurance Specialist III maintains Quality Systems and works cross-functionally with Manufacturing, Project Management, and other teams. The role identifies compliance risks before and during operations, helps prevent deviations, and manages immediate corrective actions. It ensures adherence to cGMPs and internal procedures and policies, with corrective actions documented to provide traceability and support investigations. The position primarily works in cGMP production areas, monitoring adherence to the quality system and initiating or assisting with the resolution of deviations.

Requirements

• Bachelor's degree.
• At least 5 years of GMP and QA experience in an FDA-regulated pharmaceutical environment.
• Excellent written and verbal presentation and communication skills.
• Strong problem-solving skills and ability to resolve conflict.
• Ability to effectively present information to management and/or peers.
• Comfort working independently and with individuals in other departments across the organization.
• Must pass a background check and drug screen.
• May be required to pass Occupational Health Screening.

Responsibilities

• Work cross-functionally with Manufacturing, Process Engineering, Technical Operations, Inspection, and Project Management to support Right First-Time execution of site operations.
• Review executed batch records, quality control testing data, and environmental monitoring data for compliance with internal SOPs and specifications.
• Assess lot-associated deviations, CAPA, and change controls for cumulative impact, and conduct batch disposition for clinical, developmental, and commercial products.
• Review and approve procedural changes.
• Attend client meetings and manage responses to clients regarding manufacturing or documentation issues.
• Review and approve protocols and executed validation documentation.
• Coordinate with QA Management to ensure client timelines are on schedule and attainable.
• Author or revise SOPs.
• Conduct, review, and approve deviation and OOS investigations in accordance with GMP and site quality requirements.
• Assist in developing and delivering training.
• Develop and/or present metrics for Management Review.
• Assist with compiling documentation, systems, and controls to maintain inspection-ready quality systems for regulatory and client audits, including ISO, FDA, QP, and EMEA audits.
• Participate in regulatory and client audits.
• Represent Curia Quality Assurance when managing issues requiring immediate corrective action, ensuring the action is appropriate and documented.
• Perform other duties as assigned.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior