Quality Assurance Associate

Title: QA AssociateDepartment: Quality AssuranceReports to: QA SupervisorFLSA: Non-ExemptWage$27-29 per hourSUMMARYThe QA/QC Associate is responsible for QA/QC functions and assists the Regulatory Chemist on regulatory compliance tasks. This role ensures compliance with company SOPs, cGMP, FDA, and ISO 22716 standards, while supporting quality and regulatory objectives across production and packaging operations.ESSENTIAL FUNCTIONS and RESPONSIBILITIESFollows Allure SOPs.Perform line clearance checks and approve production areas prior to start-up.Perform both online (real-time) and offline (physical) reviews of batch records to ensure compliance.Coordinate with the Production department to align on daily plans and associated manufacturing/packaging activities.Perform in-process quality checks during production or filling operations.Conduct routine sampling of bulk or finished products (Process validation or Stability or QC testing or Customers or others).Verify accuracy, availability, and proper control of current documents required for production and quality operations.Monitor manufacturing/packaging processes, identify deviations, and promptly escalate issues to QA leadership.Organize, file, and maintain QA-related documentation as directed by QA leadership.Ensure compliance with cGMP, FDA, and ISO 22716 standards at all times.Support audits, inspections, and continuous improvement initiatives as required.Review batch records for OTC and cosmetic products.Perform any other duties assigned by QA leadership.EDUCATIONA minimum of a high school diploma is required.EXPERIENCEMinimum 3 years of GMP cosmetic or OTC manufacturing experience, or 1 year of quality assurance/quality systems experience in manufacturing.KNOWLEDGE, SKILLS AND ABILITIESKnowledge of GMP, ISO, and FDA regulations.Willingness and ability to communicate and work flexibly.Basic speaking, writing, and documentation skills.Ability to multitask in technical responsibilities.Team player and able to work with minimal supervision.Strong attention to detail.Computer literate in various databases.

Created: 2025-10-02