Overview
Quality Coordinator Jobs in Mukilteo, WA at Resource Label Group, Inc
Company Background
The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.
Position Overview
Reporting to the Manager, Quality Control, the QC Analyst will be responsible for execution of tasks associated with assay transfer, qualification, validation, and execution to satisfy testing and release of Neurogene’s clinical products. Testing associated with intermediate and finished product stability studies will also be the responsibility of the QC Analyst. This individual will also be responsible for execution of raw material sampling and testing.
Support transfer and validation of analytical methods into the QC laboratory.
Operate and maintain QC lab instrumentation
Conduct testing of raw materials, intermediates, and finished products to confirm acceptance against established specifications
Execute in-process sample testing
Perform visual inspection of finished products
Draft test methods and SOPs used to execute quality control testing and complete necessary documentation to support assay results
Periodically support environmental monitoring and microbiology activities
Complete necessary documentation to support assay results
Participate in out-of-specification and laboratory investigations and recommend corrective actions when necessary
Perform other activities as assigned.
BA or BS degree in Biology, Biotechnology or related science field.
Preferred but not required: Previous experience in a Quality Control role in the gene therapy field
Knowledge of Microsoft Office products
Working knowledge of GMP/GLP operations
Understanding of typical QC instrumentation
Experience with ELISA, HPLC, PCR, SDS-PAGE, cell-based bioassay, imaging techniques, environmental monitoring, raw material testing, etc.
Cell-based assay experience preferred
Must be able to perform final fill inspections
Time management skills required for organization of daily test schedules
Record keeping skills required to ensure accuracy and authenticity of data
Organizational skills required for maintaining proper sample management
Good aseptic technique
Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
Ability to track and measure performance against defined metrics.
Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.
Majority of work is done in a lab environment; and work may involve common hazards found in a lab environment. In some areas, gowning may be required.Show more
Title: Quality Coordinator
Company: Resource Label Group, Inc
Location: Mukilteo, WA
