QA Engineer

• Analyze and oversee quality assurance of pharmaceutical product
• Identify, mitigate, and resolve regulatory compliance and quality issues that may affect drug products
• Perform batch records review and communicate any adverse findings to approved Contract Manufacturing Organizations (CMO)
• Perform product quality investigations and participate in the assessment of each investigation
• Review investigation reports and complete the timely closure of all batch record review findings prior to product release
• Resolve quality issues, and product complaints including investigations, deviations, OOS/OOT investigations, CAPAs, change controls, and quality complains related to manufacturing packaging
• Implement CAPAs and assess CAPA effectiveness
• Review and approve stability protocols and stability results
• Review and Approve Validation (process, cleaning, method) protocols and reports
• Author and review Annual Product Review
• Draft and negotiate Quality and Technical Agreements
• Provide support during regulatory inspections and audits, including Labeling development
• Implement and maintain quality systems, including change control, vendor qualification programs, internal and external audits, SOPs, and process improvement.

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