Analyst, Quality Control

Job Description

Analyst, Quality Control

Position Summary

We are seeking a detail-oriented Quality Control Analyst to support quality control testing, material inspections, documentation review, and product/material release activities. This position plays an important role in maintaining quality standards and ensuring compliance with GMP and applicable regulatory requirements.

The ideal candidate will have a strong scientific background, experience working in a quality control or analytical laboratory environment, excellent attention to detail, and the ability to effectively communicate and collaborate with internal teams, suppliers, and vendors.

Key Responsibilities

• Conduct visual inspections of purchased raw materials, components, and other materials.
• Review supplier Certificates of Analysis (CoAs) for accuracy and compliance with established requirements.
• Review and approve assays, test results, and material release documentation.
• Work with applicable USP and EP monographs to support testing and quality requirements.
• Perform aseptic sampling of raw materials and components in accordance with established procedures.
• Review, revise, and maintain SOPs, test methods, raw material specifications (RMSs), forms, and other quality documentation.
• Collaborate with suppliers and vendors to resolve quality-related questions and issues.
• Maintain accurate and complete documentation in accordance with GMP and company procedures.
• Support material release activities and ensure quality requirements are met.
• Train and provide guidance to junior analysts as needed.
• Assist with investigations, process improvements, and other quality control activities as assigned.
• Perform other duties and responsibilities as required.

Minimum Qualifications

• Bachelor’s degree in Chemistry, Biology, or a related scientific field, or equivalent relevant experience.
• 2+ years of Quality Control or analytical laboratory experience.
• Working knowledge of GMP and quality control principles.
• Experience with analytical laboratory techniques, testing, and quality documentation.
• Familiarity with USP and EP monographs preferred.
• Experience with aseptic sampling preferred.
• Strong attention to detail and ability to accurately review technical documentation.
• Strong written and verbal communication skills.
• Ability to work independently while also collaborating effectively with cross-functional teams.
• Ability to prioritize multiple tasks and meet deadlines in a fast-paced environment.

Preferred Qualifications

• Experience in a pharmaceutical, biotechnology, or other regulated laboratory environment.
• Experience reviewing Certificates of Analysis and material release documentation.
• Experience with SOPs, test methods, specifications, and controlled documents.
• Previous experience training or mentoring junior laboratory personnel.