Specialist I, QA

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+).