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six sigma erp systems fmea qms dmaic📋 Description
- Ensure compliance across all quality systems.
- Review/approve SOPs, investigations, CAPAs, and data reviews.
- Review batch records for completeness, accuracy, and release.
- Apply Six Sigma tools to improve investigations and CAPAs.
- Oversee MQA, Receiving Inspection, and QA Operations on site.
- Lead QA staff training and development.
🎯 Requirements
- Bachelor's degree in Science, Engineering, or related field.
- 7–10 years pharma QA with 4+ years in management.
- Experience with product/system investigations and RCA; Six Sigma.
- FDA inspections and third-party audits experience.
- Knowledge of cGMP, ICH Q7–Q10, USP, ISO 9001, MoCRA.
- Strong data integrity, ALCOA+ and ERP/document management.
🎁 Benefits
- Flexible PTO (12 days), holidays, and parental leave.
- Healthcare benefits and wellness discounts.
- HSA and 401k match.
- Employer-paid life and disability insurance.
- Pet insurance and wellness perks.
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