Quality Control Associate

Job Description

Job Description

Quality Control Associate

Department: Quality Control
Location: Tustin, CA

Position Summary

The Quality Control Analyst supports quality and regulatory compliance by performing material inspections, reviewing analytical documentation, conducting aseptic sampling, and supporting material release activities. This role ensures that raw materials and components meet established quality standards and applicable regulatory requirements, including Good Manufacturing Practices (GMP).

Key Responsibilities

• Conduct visual inspections of purchased materials to ensure they meet established quality standards.
• Review supplier Certificates of Analysis (COAs) for accuracy and compliance with specifications.
• Review and approve analytical assays, test results, and material release documentation.
• Apply USP and EP monographs to support quality control testing and material evaluations.
• Perform aseptic sampling of raw materials and components in accordance with established procedures.
• Review, revise, and maintain Standard Operating Procedures (SOPs), test methods, Raw Material Specifications (RMSs), and related forms.
• Communicate and collaborate with suppliers and vendors to address quality-related questions and documentation requirements.
• Train and provide guidance to junior analysts to support consistent procedures and compliance.
• Maintain accurate documentation and follow applicable quality standards, regulatory requirements, and internal procedures.
• Perform additional duties as assigned.

Minimum Qualifications

• Bachelor's degree in Chemistry, Biology, or a related scientific field, or equivalent relevant experience.
• At least 2 years of experience in quality control, analytical laboratory testing, or a related field.
• Working knowledge of Good Manufacturing Practices (GMP) and quality control principles.
• Experience with analytical testing techniques, technical documentation, and quality records.
• Familiarity with USP and EP compendial requirements is preferred.
• Strong attention to detail, organizational skills, and written and verbal communication abilities.
• Ability to follow established procedures and maintain accurate, compliant documentation.

Ideal Candidate

The ideal candidate is detail-oriented, organized, and comfortable working in a regulated environment. They can review technical documentation, identify discrepancies, follow established quality procedures, and collaborate effectively with internal teams and external suppliers to support product quality and regulatory compliance.