Quality Assurance Specialist

Position Title :

Quality Assurance Specialist Pay Rate :

$20.00+ DOE (Non-Exempt) Reports to:

Quality Supervisor Position Summary :

The Quality Specialist is responsible for supporting the Quality Management System (QMS) by managing investigations, documentation, and resolution of quality events including rework, deviations, nonconformances, and customer complaints. This role ensures compliance with internal procedures, regulatory requirements (e.g., FDA, ISO), and customer expectations while driving continuous improvement.

Key Duties/Responsibilities:

1. Nonconformance Management (NCM) Identify, document, and investigate nonconforming materials (raw, bulk, and finished goods) Evaluate product impact and support risk-based disposition decisions (rework, release, reject) Collaborate with Production, QC, and Supply Chain to ensure timely and compliant resolution 2. Deviation Management Initiate, document, and investigate deviations from established procedures or specifications Perform structured root cause analysis (e.g., 5 Whys, Fishbone, trend analysis) Support implementation of corrective and preventive actions (CAPA) Ensure deviations are closed within defined timelines with effectiveness verification 3. Rework & Reprocessing Review and approve rework/reprocessing instructions in alignment with quality and regulatory requirements Assess impact of rework on product quality, stability, and compliance Ensure proper documentation, traceability, and approval prior to execution Collaborate with Manufacturing and QC to ensure controlled execution 4. Customer Complaints Conduct thorough investigations of customer complaints with timely closure Conduct root cause analysis and determine product impact and risk Coordinate with internal teams to implement corrective actions Prepare clear, professional, audit-ready responses to customers Trend complaint data and identify systemic or recurring issues 5. Documentation & Compliance Maintain accurate, complete, and audit-ready quality records Ensure compliance with applicable regulations (21 CFR 210/211, ISO standards as applicable) Support internal and external audits, including data compilation and response development 6. Continuous Improvement Analyze trends related to deviations, complaints, and nonconformances Recommend and implement process improvements to reduce recurrence and improve efficiency Participate in cross-functional quality and operational meetings to drive quality-focused decision making

Skills and Abilities:

Ø Strong attention to detail and organizational skills Ø Ability to manage multiple priorities and meet deadlines Ø Effective written and verbal communication, including technical writing Ø Cross-functional collaboration skills Ø Proficiency in quality systems and documentation tools (e.g., ERP, QMS software) Education and Experience

• High school diploma or equivalent required
• Experience in Quality Assurance, Manufacturing, or a regulated industry (e.g., FDA, ISO) preferred
• Minimum 1 year of experience (preferable) Working Conditions/Job Environment This job operates in a professional office environment.

This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Some of the work will require exposure to loud noises or fumes in the plant facility. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions.

Pay:

From $20.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Vision insurance Ability to

Commute:

Chino, CA 91710 (Required)

Work Location:

In person