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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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or .