Job Summary

The Quality Assurance Specialist I supports quality and regulatory compliance within a GMP-regulated environment by reviewing documentation, conducting floor audits, maintaining quality systems, and ensuring adherence to internal procedures and applicable regulations.

Responsibilities

• Review and approve quality documents, data, protocols, and reports.
• Conduct floor audits and inspections to ensure GMP compliance.
• Review, write, and approve change controls, deviations, CAPAs, OOS investigations, and raw material specifications.
• Evaluate and release support materials and intermediate products as required.
• Maintain accurate quality records and documentation.
• Assist with SOP development and continuous quality improvement initiatives.
• Support client audits and regulatory inspections.
• Ensure compliance with company policies, SOPs, and required training.

Qualifications

• Associate’s degree in Chemistry, Biology, or a related field, with 1–2+ years of GMP experience, or equivalent education and experience.
• Knowledge of GMP regulations, ICH Q7, quality systems, and technical writing.
• Strong written and verbal communication, critical thinking, and problem-solving skills.
• Proficiency in Microsoft Office, including Word, Excel, Outlook, and PowerPoint.
• Ability to manage priorities, work independently, and collaborate effectively across teams.