Quality Control - Raw Materials

Job Description

Job Description

Quality Control – Raw Materials

Job Summary

We are seeking a detail-oriented Quality Control Analyst with experience inspecting and testing raw materials in a pharmaceutical, biotechnology, or manufacturing environment. This individual will be responsible for evaluating incoming materials, reviewing supplier documentation, performing aseptic sampling, and ensuring materials meet established quality standards and regulatory requirements. The ideal candidate will have experience working with USP and EP monographs, Certificates of Analysis (COAs), and quality documentation.

Key Responsibilities

• Conduct visual inspections of incoming raw materials and purchased components to ensure they meet established quality standards.
• Review and verify supplier Certificates of Analysis (COAs) for accuracy, completeness, and compliance with specifications.
• Review and approve analytical assays, test results, and material release documentation.
• Interpret and apply USP and EP monographs when evaluating raw material quality and testing requirements.
• 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 quality forms.
• Collaborate with suppliers and vendors to address material quality concerns, documentation discrepancies, and compliance issues.
• Ensure all testing, inspections, and documentation are completed in accordance with applicable quality standards and regulatory requirements.
• Train and provide guidance to junior analysts on testing procedures, documentation practices, and quality standards.
• Perform additional quality control and laboratory duties as assigned.

Qualifications

• Previous experience in Quality Control, Quality Assurance, or raw material inspection within a pharmaceutical, biotechnology, or manufacturing environment.
• Hands-on experience with raw material sampling, inspection, and testing.
• Familiarity with USP and EP monographs and pharmaceutical quality standards.
• Experience reviewing Certificates of Analysis (COAs), assays, and material release documentation.
• Knowledge of SOPs, test methods, and raw material specifications.
• Strong documentation, organizational, and attention-to-detail skills.
• Ability to work independently while collaborating with cross-functional teams and external suppliers.
• Previous experience training or mentoring junior analysts is preferred.

Preferred Experience

• Experience working in a GMP-regulated environment.
• Familiarity with aseptic sampling techniques and laboratory procedures.
• Experience supporting incoming material qualification and release processes.