Operational Quality Assurance Supervisor

Danaher • Fargo, ND

2d

About The Position

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
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.

Requirements

• 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

Nice To Haves

• 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.).

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees