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six sigma ich root cause analysis qms capa📋 Description
- Lead site Quality Systems to ensure FDA/ICH compliance.
- Oversee QA Operations, MQA, Receiving Inspection, batch release.
- Apply RCA and Six Sigma to CAPAs and continuous improvement.
- Ensure ALCOA+ data integrity and robust document control.
- Collaborate with Manufacturing, QC, R&D, and Supply Chain on issues.
🎯 Requirements
- Bachelor's degree in Science, Engineering, or related field.
- 7–10 years pharma QA experience, with >=4 years in leadership.
- Direct experience with product/system investigations and RCA.
- Six Sigma DMAIC, FMEA, and CAPA expertise.
- FDA inspections and third-party audits experience.
- Knowledge of cGMP, 21 CFR Parts 11/210/211, ICH Q7–Q10, ALCOA+.
- ERP/QMS systems, data integrity and trend analysis.
- Strong leadership and cross-functional collaboration skills.
🎁 Benefits
- Competitive compensation including base salary and bonus.
- Flexible PTO, holidays, and parental leave.
- Comprehensive benefits: health, HSA match, 401k match.
- Employer-paid life and disability insurance.
- Pet insurance and wellness discounts.
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