Quality Control Analyst II

$62,000 - $78,100/Yr

Curia - Camarillo, CA

Full-time - Mid Level

Camarillo, CA

About the position

The Quality Control Analyst II at Curia is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and stability samples. This role involves participation in special projects, method development, transfers, and cleaning study qualifications, contributing to the overall quality assurance in the pharmaceutical manufacturing process.

Responsibilities

• Perform analytical testing for incoming, in-process and final products, and stability samples using various laboratory equipment.
• Conduct chromatography (HPLC/GC, UPLC) and wet chemistry assays with minimal qualification and training.
• Maintain and calibrate QC analytical instruments and perform general laboratory equipment maintenance.
• Assist with QC method qualifications, transfers, validations, and method development.
• Conduct cleaning validation studies and assist in evaluating new equipment and processes.
• Review QC data and provide summaries to management as needed.
• Assist QC Management in completing OOS, deviations, and CAPAs investigations for QC.
• Manage the receipt, processing, shipment, tracking, and distribution of analytical samples.

Requirements

• Bachelor's degree in Chemistry or related field.
• Minimum 3-5 years' experience in a pharmaceutical industry environment or equivalent combination of education and experience.
• Experience working in cGMP or GLP pharmaceutical industry environment is preferred.
• Excellent verbal and written communication skills.
• Strong time management and organizational skills with the ability to multi-task.
• Proficient in Microsoft Office Suite and instrument manufacture-based systems.
• Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 is a plus.

Nice-to-haves

• Experience with analytical chemistry assays and laboratory equipment.
• Ability to apply advanced mathematical concepts and statistical analysis techniques.

Benefits

• Competitive salary range of $62,000 - $78,100 per year.
• Opportunities for professional development and training.