Regeneron Hiring Quality Control Virology Analyst – Apply Online
Regeneron is currently looking for a Quality Control (QC) Virology Analyst with a 1st shift, Monday-Friday, 8 am-4:30 pm schedule. We support assay lifecycle management within QC Virology. We use and apply scientific knowledge and techniques to perform and review assay characterization, optimization, transfer, validation and investigation for QC Virology. We provide guidance, technical advice, and supervision for in-process testing, and assay development as subject matter experts (SME).
Job Title: Quality Control Virology Analyst
Location East Greenbush, New York, United States of America
Category Industrial Operations and Product Supply
Job Id R11538
Eligibility Criteria:Â
As a QC Virology Analyst, a typical day might include the following:
- Engages with QC Virology Technology to bring methods to QC Virology Operations before process validation, evaluates and determines the appropriate methods and reagents to implement within QC Virology Operations.
- Analyzes and monitors day-to-day method performance in QC Virology Operations lab, including determining if problem resolution requires an appropriate subject matter expert to help with any method-related issues.
- Works directly with Regulatory Sciences, External Manufacturing, and collaborators; communicates timelines for method validation, method transfers, and product-specific qualifications to managers in QC Virology Operations.
- Communicates method updates to partners and tracks the progress of updates.
- Analyzes assemble, and/or coordinates assay application and implementation reports and quality metrics.
- Assesses and implements multi-site method harmonization and performs a review of multi-site method performance.
- Participates in and coordinates post-transfer/validation/qualification investigations between contract laboratory sites, collaborative partners, and QC Virology Operations.
- Tracks team activities and timelines to ensure that the deliverables within the project plans are met and on time.
- Raises issues to management, as needed.
- Continuously aims to improve processes for improved performance.
- Performs and/or coordinates method validation and/or product-specific qualification for the QC Virology Operations team.
- Implements new assays and associated test procedures for QC Virology Operations.
- Performs and/or coordinates with QC Technical Resources for assay transfers
- Authors and/or coordinates technical document preparation (including, but not limited to: technical justification documents, Assay Validation Protocols, Assay Validation
- Reports, Product Qualification Reports).
- Participate in training programs for QC Virology personnel
This role might be for you if you have:
- Ability to work independently or as part of a team.
- Ability to communicate with transparency.
- Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
- Skilled at gathering and organizing information.
- Ability to follow directions and perform well-defined tasks.
- Effective time management skills.
- Excellent written and oral communication skills.
- Ability to develop strategy and create metrics to measure the effectiveness of the strategy.
- Ability to identify and effectively communicate risks.
Regeneron Hiring
