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 :
Bachelors 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.Benefits :
401(k) matchingDental insuranceHealth insuranceLife insurancePaid time offTuition reimbursementKey Skills
Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP
Employment Type : Full Time
Experience : years
Vacancy : 1