Quality Systems Specialist
AGSIIrvine, CA, California, USAjob_description.job_card.variable_hours_ago
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job_description.job_card.job_descriptionBachelor's degree in Quality Management, Life Sciences, Engineering, or a related field. 5+ years of progressive experience in QA / QC within manufacturing, preferably in food, supplements, or pharmaceutical industries. In-depth knowledge of cGMP, FDA, HACCP, and other regulatory frameworks. Exceptional analytical, problem-solving, and decision-making skills. Proficiency in quality tools and systems (e.g., CAPA, RCA, Six Sigma methodologies). Excellent verbal and written communication skills. 401(k) matching Dental insurance Health insurance Life insurance Paid time off Tuition reimbursement
Job Title : Quality Systems Specialist
Location : Irvine, CA
Pay : $31–$39 / hour
Direct Hire / Open to Temp-to-hire
Schedule : (M-F) 7 : 30 AM – 4 PM
Job Responsibilities :
- Develop, update, and enforce Standard Operating Procedures (SOPs), Sanitation Standard Operating Procedures (SSOPs), cGMP protocols, and quality policies.
- Oversee the implementation and adherence to quality standards across the production floor, ensuring proper documentation and traceability.
- Review and approve quality documentation including batch records, deviation reports, CAPAs, and quality logs.
- Establish and maintain quality metrics and KPIs to evaluate product and process quality across production stages.
- Manage the calibration, maintenance, and validation of testing equipment and QA tools.
- Analyze trends from quality data and root cause investigations to recommend preventive and corrective actions.
- Collaborate with production, R&D, and supply chain teams to optimize processes and resolve quality-related issues.
- Drive continuous improvement initiatives and lead quality-related projects to reduce defects and increase efficiency.
- Provide regular quality reports and presentations to senior management highlighting key findings, risks, and improvement opportunities.
- Ensure timely and accurate recording of test results and quality incidents.
Qualifications :
Benefits :
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Quality Specialist • Irvine, CA, California, USA