Sr Associate, Laboratory Process Improvement

GeneDx • Gaithersburg, MD

2d • Onsite

About The Position

The Process Improvement Senior Associate is responsible for providing technical, scientific, and/or clinical expertise in process improvement projects, focusing on optimizing workflows, ensuring quality compliance, and leading validation efforts in the molecular genetics lab.

Requirements

• Bachelor’s degree in Molecular Biology, Genetics, Biotechnology, Genetic Counseling or a related field; PhD in Biology, Genetics or related field; MD or DO with experience in human genetics
• 4+ years of experience in a laboratory or process improvement setting
• Strong data analysis, problem-solving, and project management skills
• Experience with regulatory compliance, documentation, and validation principles
• Either ABMGG Diplomate or equivalent, certified in at least one specialty, or Certification by the American Board of Genetic Counseling (ABGC) or equivalent is required for relevant positions
• For Genetic Counselors: Licensure is required in the state where the employee works, if applicable. Genetic counseling licenses for additional states may be required at the discretion of GeneDx

Nice To Haves

• Familiarity with Lean Six Sigma or similar methodologies is preferred

Responsibilities

• Analyze laboratory workflows and identify process inefficiencies
• Develop and implement workflow optimizations and maintain process documentation
• Ensure process changes meet regulatory requirements and quality standards
• Develop and refine SOPs and training materials for process improvements
• Provide troubleshooting support for complex process inefficiencies
• Mentor junior associates on process improvement methodologies and best practices
• Supports validation efforts for new and improved production processes, including assisting in protocol development, data collection, and documentation
• Ensures all process changes meet regulatory requirements and quality standards
• Works with cross-functional teams to communicate and implement findings
• Support and train production personnel in process improvement and/or new process workflows
• Performs other duties assigned in support of the team or department

Benefits

• Paid Time Off (PTO)
• Health, Dental, Vision and Life insurance
• 401k Retirement Savings Plan
• Employee Discounts
• Voluntary benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level