Job Scope:

The QA Operations Lead role is to ensure that end-products are meeting quality pre-established standards, through inspecting and monitoring both products, procedures and processes. 

Reporting to: QA Sr Manager

Key Responsibilities:

• Investigating any non-conformity or complaints and taking corrective measures.
• Monitoring procedures, analyzing issues, and reporting any repetitive problems.
• Performing routine GEMBA walks in production are and identify opportunities of improvement.
• Inspecting and releasing outgoing products.
• Implementing and optimizing processes to ensure that products consistently or exceed established quality standards.
• Participating in the Internal Audits of QMS per the established annual schedule
• Participating in the vendors qualification program.
• Providing proper methods for reporting.
• Other quality related tasks as assigned.

Qualifications

• Bachelor's degree in the scientific discipline of molecular biology, chemistry, biochemistry, pharmaceutical science, chemical engineering or related field.
• 5 years of relevant experience in Quality Assurance or Quality Control experience in a ISO9001 or GMP manufacturing environment will be prioritized.
• Excellent written and verbal communication skills with internal and external customers, peers and managers. 
• Individual may be required to sit, stand, walk regularly in production are, and occasionally lift 0-15 pounds.

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