Operational Quality Assurance Supervisor

Job Summary

The primary function of this role is to provide Quality and compliance leadership and direct supervision for in-process reviews of manufacturing packaging labeling laboratory operations technical services storage distribution and quality systems at Aldevron. This individual will support and execute company directives policies processes and procedures in support of this objective. Additionally the OQA Supervisor (2nd Shift) will help resolve any quality issues on areas of oversight that impact manufacturing delays and successfully address complex problems or development and implementation of robust preventative or corrective actions to enhance overall operational reviews.

This position is 2nd shift.

Job Responsibilities

• Manage train develop and mentor a team of OQA professionals while providing technical input and justification for release or rejection of OQA reviews
• Provides on-the-floor Quality oversight of manufacturing inspection packaging labeling warehousing and provides timely input to enable compliant and timely operations
• Serves as the Subject Matter Expert (SME) in assessing the impact of excursions and deviations that occur during operations
• Performs real time batch record review on the floor to reduce or eliminate errors and improve Right First Time (RFT)
• Supports a program to ensure timely batch record review resolution of batch-related investigations and review of laboratory test results to enable a smooth release of finished product
• Collaborate with internal partners in other parts of Quality Assurance (QA) Quality Control (QC) Technical Operations manufacturing and Supply Chain to resolve issues
• Manages reviewed and in-process documentation necessary for in-process releases including solution preparations in-process QC testing and SOPs

Qualifications

• 3 years of relevant experience in a quality position required
• 2 years of that experience in a lead supervisory or managerial position
• Direct experience with regulatory or internal audits and inspections
• Bachelor of Science preferred.
• Life science related field preferred or equivalent experience.
• 5% travel

Additional Skills

• Experience in process understanding as it pertains to cGMP manufacturing
• Comprehensive understanding of cGMP manufacturing expectations
• Exposure to regulatory agency inspections or other types of audits (e.g. FDA notified bodies ISO etc.).

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