Quality Assurance Specialist

Job SummaryThe 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.ResponsibilitiesReview 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.QualificationsAssociate’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.