<p>Essential Duties and Responsibilities</p> <ul> <li>Lead and manage investigations for deviations, non-conformances, and customer complaints, including root cause analysis, product impact assessment, and timely closure. </li><li>Drive and monitor CAPA activities to ensure effective, compliant, and sustainable corrective actions. </li><li>Support validation activities and maintain compliance with cGMP (21 CFR 211) and ALCOA+ data integrity standards. </li><li>Support change control, SOP development, and batch record review to ensure accuracy and regulatory compliance. </li><li>Serve as SME during internal, customer, ISO, and FDA audits, including preparation and response support. </li><li>Perform risk assessments and trend analysis (including complaints) and collaborate cross-functionally to strengthen quality systems and drive continuous improvement. </li></ul> <p>Knowledge, skills, and abilities</p> <ul> <li>Strong knowledge of FDA regulations (21 CFR 210/211) and GMP. </li><li>Experience with validation principles and data integrity (ALCOA+). </li><li>Strong investigation and root cause analysis skills. </li><li>Experience handling customer complaints and regulatory reporting expectations. </li><li>Excellent technical writing skills and organizational skills. </li><li>Ability to manage multiple priorities. </li><li>Strong communication and teamwork skills. </li><li>Pay range $32.00 - $37.00 per hour. </li></ul> <p>Education and/or Experience</p> <ul> <li>Bachelor's degree in Science, Engineering, or related field (preferred). </li><li>Minimum 3-5 years of experience in Quality Assurance within a pharmaceutical, OTC, cosmetic, or regulated manufacturing environment. </li><li>Experience with deviations, CAPA, investigations, validation (IQ/OQ/PQ, cleaning), and regulatory/customer audits. </li><li>Computer literate, with proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. </li><li>Experience supporting audits, customer visits, customer meetings, and classroom training experience. </li><li>Strong communication and public speaking skills. </li><li>Bilingual (English/Spanish) is a plus. </li><li>Experience using and navigating ERP systems (SAP+). </li></ul>