Clinical Laboratory Production Manager 

Responsibilities: 

• Develop and coordinate team shifts for all lab processes during a given shift, ensuring the right balance of trained technical personnel to meet the needs of the assay and incoming sample volume 
• Develop and execute a clean and clearly communicated handoff of work between shifts
• Collaborate with management and business operations to understand the operating metrics of the team and where bottlenecks or execution issues impact quality or turnaround time 
• Act as the point person for technical guidance for ongoing processes
• Consider and propose workflow improvements to accommodate growing volume, introduction of laboratory automation, and introduction of new products 
• Compliance and support for all components of our quality management system.
• Monitor team and facility for compliance with relevant environmental, health, and safety requirements 

Qualifications: 

• Experience (2+ years) leading a team executing molecular testing in a clinical diagnostic environment (CAP/CLIA, ISO, cGMP) 
• Familiarity with reporting of deviations, root cause analysis, and CAPA processes
• Qualifications compatible with Massachusetts and/or New York CLIA General Supervisor classification (per CFR § 493.1461 ) are desirable but not required
• Bachelors/Masters degree in a biological or clinical field 
• Preference will be given to 2nd/3rd shift candidates but excellent 1st shift candidates should be encouraged to apply