Quality Systems Specialist

Irvine, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Tuition reimbursement

Job Title: Quality Systems SpecialistLocation: Irvine CAPay: $31$39/hourDirect Hire/Open to Temp-to-hireSchedule: (M-F) 7:30 AM 4 PMJob Responsibilities: Develop update and enforce Standard Operating Procedures (SOPs) Sanitation Standard Operating Procedures (SSOPs) cGMP protocols and quality poli...