Job Title

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