Job Title: Quality Assurance Specialist
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We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.
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Your key responsibilities will include:
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1. Performing batches of manufactured commercial batches and preparing release documents for approval.
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2. Conducting Statistical Control activities downstream of inspection for products in DPS & PDS areas.
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3. Training personnel involved in quality activities.
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4. SUPPORTING investigation teams in handling quality issues of batches for clinical and commercial use by identifying corrective and preventive actions.
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5. Collaborating on CAPAs management resulting from quality investigations, verifying their effectiveness over time.
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6. Participating in initiatives/projects aimed at Operational Excellence.
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7. Attending all meetings related to new and ongoing projects.
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8. Coordinating technical and management meetings with customers.
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9. SUPPORTING during client/quality inspections (Audits) and internal/regulatory inspections.
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10. Generating reports on quality events.
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11. Contributing to achieving quality objectives related to job responsibilities, including RFT, Deviation Rate, Past due, and On-time closure goals.
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12. Collaborating with Compliance colleagues in reviewing Quality System SOPs within the scope of the Quality Unit.
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13. Providing customer support via TLC and email, promptly responding to quality inquiries.
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14. Assisting in drafting FMEAs.
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15. Managing drafting, archiving, and distribution of controlled company documentation.
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16. Within PDS, performing document issuing activities to support Production, PPT, and Quality System colleagues.
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17. Drafting and reviewing QATs with customers and site QPs.
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18. Participating in PPI initiatives (Kaizen and Gemba) supporting continuous site improvement.
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19. SUPPORTING team and other functions to ensure readiness and support for BUs processes.
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