Quality Control Inspector

Job Description: Quality Analyst – Raw Ingredients (Biopharmaceutical)

Location: Tustin, CA

Industry: Biopharmaceutical / Biotechnology

Department: Quality Control / Quality Assurance

Position Summary

We are seeking a detail-oriented Quality Analyst to support the quality control of raw materials and ingredients used in biopharmaceutical manufacturing. This position is responsible for inspecting, sampling, reviewing, and testing incoming raw materials to ensure they meet established quality standards, specifications, and regulatory requirements.

The ideal candidate will have experience working in a laboratory, pharmaceutical, biotechnology, or other regulated manufacturing environment, with an understanding of Good Manufacturing Practices (GMP) and quality documentation.

Key Responsibilities

• Inspect and verify incoming raw materials, ingredients, and components against approved specifications and documentation.
• Collect and prepare raw material samples for quality control testing.
• Review Certificates of Analysis (COAs), material specifications, and supplier documentation.
• Perform or coordinate laboratory testing to verify material identity, purity, quality, and compliance with established requirements.
• Review test results and document findings accurately in accordance with GMP procedures.
• Maintain material status records, including approved, quarantined, rejected, and released materials.
• Identify, document, and report material discrepancies, out-of-specification results, and quality issues.
• Assist with investigations, deviations, corrective and preventive actions (CAPAs), and other quality-related activities.
• Ensure compliance with Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and applicable FDA requirements.
• Maintain accurate records in laboratory systems, inventory systems, and electronic quality management systems.
• Communicate with Quality Control, Quality Assurance, Warehouse, Manufacturing, and Supply Chain teams regarding material status and quality concerns.
• Maintain a clean, organized, and compliant laboratory and work environment.

Qualifications

• Associate degree or bachelor's degree in Biology, Chemistry, Biochemistry, Biotechnology, or a related life sciences field preferred.
• Previous experience in quality control, quality assurance, laboratory testing, raw material inspection, or pharmaceutical/biopharmaceutical manufacturing preferred.
• Knowledge of GMP, SOPs, GDP, and quality control procedures.
• Experience reviewing Certificates of Analysis and material specifications is a plus.
• Strong attention to detail and ability to accurately review technical documentation and test results.
• Basic laboratory skills and familiarity with sample preparation and testing procedures.
• Proficiency with Microsoft Office and electronic documentation systems.
• Strong organizational, communication, and problem-solving skills.

Preferred Experience

• Experience with incoming raw material qualification or release.
• Familiarity with pharmaceutical or biopharmaceutical ingredients, chemicals, buffers, media, or excipients.
• Experience with laboratory instruments and analytical testing methods.
• Understanding of FDA-regulated manufacturing environments and material traceability.

Work Environment

This position may involve working in a laboratory, manufacturing, or warehouse environment. Employees must follow applicable safety procedures, wear required personal protective equipment (PPE), and comply with facility quality and contamination-control requirements.

Ideal Candidate: A quality-focused professional with strong documentation skills and experience evaluating raw materials to ensure they meet the standards required for biopharmaceutical production.