Quality Assurance Specialist

Quality Assurance Specialist Alleva Manufacturing LLC Pomona, CA Job Details Part-time $35 - $40 an hour 1 day ago Qualifications Teamwork Organizational skills Quality audits Root cause analysis Validation design Technical Writing FDA regulations Method validation Full Job Description 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

FDA QMSR.

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. 20 hours per week Knowledge, skills, and abilities Strong knowledge of FDA regulations (21 CFR 210/211) and QMSR. Experience with validation principles 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:

$35.00 - $40.00 per hour

Work Location:

In person