The Quality Assurance Assistant supports the QA Manager in overseeing and improving quality systems, ensuring product and process compliance with industry regulations, customer specifications, and internal standards. This role assists in leading the QA Team, manages audits and documentation, and actively contributes to continuous improvement and operational excellence.

Job Responsibilities

Support the Quality Manger in developing, implementing and maintaining QA systems, and policies. Assist in the development and implementation of QA procedures, systems, and protocols. Maintain and update QA logs and records. Monitor manufacturing processes to ensure compliance with Good Manufacturing Practices (cGMP). Participate in audits and support external inspections - this includes processes, checklists, and procedures. Monitor and review quality metrics, trends, and KPI's' initiate corrective and preventive actions as needed. Document quality problems and customer complaints by using Nonconformance Report (NCR) and Correction/Preventive Action Report (CAPA). Collaborate with cross-functional teams (production, R & D design, project teams) to resolve quality issues and drive improvements. Facilitate and assist with resolution of customer complaints. Identify opportunities for process improvement and implement measures to enhance overall product quality. Promote and implement the 6S methodology. Provide training and mentoring the QA staff in policies, procedures, and standards; ensure all team members understand quality standards. Skills/ Qualifications Thorough knowledge of methodologies of quality assurance and standards. Excellent numerical skills and understanding of data analysis/statistical methods. Excellent verbal and written communication skills. (Bilingual English /Spanish a plus) Outstanding planning and organizing skills that relate to quality processes. Strong knowledge of continuous improvement processes, problem analysis and resolution. Proficient computer skills and knowledge application to the job (i.e. Microsoft Word, Excel, internet, email) as well as proficiency in the use of in-house programs and applications. Excellent customer service skills and the ability to handle multiple duties and assignments effectively and efficiently. Attention to detail and commitment to quality. Ability to work collaboratively across departments. Bachelor's degree in quality assurance/engineer or related field preferred. 3-5+ years of experience in quality assurance or regulatory environments. Knowledge of GMP, ISO or other regulatory requirements. Physical Demands & Working Conditions Required to stand, walk, and sit for extended periods of time during the course of work shift. Required to regularly stoop, bend, kneel, lift, and reach, in the performance of this role. Required the use of hands, speech and hearing, and use of feet to operate machinery/equipment; Agility to operate and frequently be exposed to moving mechanical parts. Lifting requirements: 25-35 lbs.; and the ability to move/push up to 25 lbs. The noise level in this work environment may be moderate to high. Occasionally exposed to high, precarious places, fumes or airborne particles, outside weather conditions. PPE requirements: Regular use of safety glasses, standard ear plugs, masks, safety shoes, and gloves.

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