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Quality Systems Specialist
Quality Systems SpecialistAGSI • Irvine, California, USA
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Quality Systems Specialist

Quality Systems Specialist

AGSI • Irvine, California, USA
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
  • [job_card.permanent]
[job_card.job_description]

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
  • Key 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

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