Quality Assurance Specialist III

Curia • Camarillo, CA

1d • $91,000 - $114,200 • Onsite

About The Position

The Quality Assurance Specialist III maintains Quality Systems and works cross-functionally with Manufacturing, Project Management, and other departments. 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, and that corrective actions are appropriate and documented to support traceability and investigation findings. The position primarily works in cGMP production areas, overseeing adherence to the quality system and initiating or assisting with the resolution of deviations.

Requirements

• Bachelor’s degree.
• A minimum of 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 the ability to resolve conflict.
• Ability to effectively present information to management and/or peers.
• Ability to work independently and with individuals in other departments across the organization.
• Must pass a background check.
• Must pass a 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 the cumulative impact of lot-associated deviations, CAPA, and change controls, 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 in compiling documentation, systems, and controls to maintain inspection-ready quality systems for regulatory and client audits, including ISO, FDA, QP, and EMEA requirements.
• Participate in regulatory and client audits.
• Represent Curia Quality Assurance in managing issues requiring immediate corrective action and ensure 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