QC Manager - Ambernath

Role & responsibilities

• Conduct functional, performance, stability, and reliability testing of IVD instruments.
  
• Develop and standardize QC protocols for hardware, firmware, and system-level performance.
  
• Validate calibration, precision, and repeatability of instrument test results.
  
• Perform environmental and stress testing to ensure robustness of instruments.
  
• Support product development by testing prototypes and providing QC data to R&D.
  
• Investigate instrument malfunctions during QC and provide feedback for improvements.
  
• Collaborate with service teams to analyze field performance and incorporate learnings into QC processes.
  
• Maintain QC test logs, calibration records, and instrument performance data.
  

Responsibilities Reagents

• Conduct chemical, biochemical, and functional testing of reagent batches.
  
• Ensure lot-to-lot consistency, stability, and accuracy of reagents.
  
• Develop and optimize QC test methods specific to reagent performance with instruments.
  
• Perform precision, sensitivity, and linearity testing of reagents.
  
• Maintain control samples and reference standards for reagent QC.
  
• Support troubleshooting of reagent-related issues in coordination with production and service teams.
  
• Document reagent QC results and prepare stability and shelf-life reports.
  

Team Management & Leadership

• Lead, train, and mentor the QC team to ensure adherence to test protocols and accuracy.
  
• Allocate resources, assign tasks, and monitor team performance for timely QC operations.
  
• Conduct regular training on instruments, reagents, and testing procedures.
  
• Drive continuous improvement initiatives within the QC department.
  
• Ensure proper maintenance and availability of QC equipment and consumables

Preferred candidate profile

• M.Sc. or B.Sc. in Biochemistry or Chemistry

  (mandatory).
• 10 12 years of experience in Quality Control, with at least 3–5 years in a leadership role.
  
• Strong knowledge of QC testing methods for IVD instruments and reagents.
  
• Hands-on experience with calibration, stability studies, and performance validation.
  
• Excellent troubleshooting and analytical skills.
  
• Proven ability to lead a QC team and manage multiple priorities.
  
• Strong documentation, reporting, and data interpretation skills.