Aldevron · 4 days ago
Operational Quality Assurance Supervisor
Fargo, ND
Full-time
Onsite
Mid, Senior Level
3+ years expAldevron is a company focused on advancing science to shape the future of medicine. The Operational Quality Assurance Supervisor will provide leadership and supervision for quality and compliance in various manufacturing processes, ensuring adherence to standards and resolving quality issues.
BiotechnologyCommercialIndustrialManufacturing
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
Qualification
Required
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
5% travel
Preferred
Bachelor of Science preferred
Life science related field preferred or equivalent experience
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.)
Company
Aldevron
Aldevron is a biological development and manufacturing organization specializing in cell and genetic engineering.
1001-5000 employees
H1B Sponsorship
Aldevron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (8)
2023 (10)
2022 (6)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
TA Associates
2021-06-17Acquired
2019-01-01Private Equity
2017-01-24Private Equity
Leadership Team
Kevin Ballinger
Chief Executive Officer
Nathan Spangler
Senior Director, IVT mRNA Services Platform
Recent News
Company data provided by crunchbase