QC Supervisor

• Supervise daily QC laboratory operations and related bioanalytical methods
• Ensure assays are performed in compliance with SOPs, ISO 9001, and regulatory requirements
• Review and approve QC data, calculations, trends, and reports for accuracy and compliance
• Lead and support investigations related to OOS/OOT results, product variability, and system suitability failures
• Provide technical guidance on assay troubleshooting, optimization, and robustness
• Manage training and qualification of QC analysts on SOPs
• Support product validation, transfer, and lifecycle management of veterinary diagnostic products
• Oversee reagent qualification, critical material management, and reference standard control
• Ensure laboratory equipment is qualified, calibrated, and maintained
• Partner with Quality, Manufacturing, and Process Development to resolve quality and assay-related issues
• Support internal, client, and regulatory audits and inspections
• Drive continuous improvement initiatives related to assay performance, throughput, and compliance

• Bachelor’s degree (with 5 years industry experience) or Master’s degree (with 2 years of industry experience) in Biochemistry, Chemistry, Immunology, Bioanalytical Science, or a related field
• 1-2 years of supervisory or technical lead experience
• Experience supporting regulatory inspections involving bioanalytical or immunoassay methods
• Experience in CLSI guidelines on assay validation (Accuracy, precision, sensitivity, specificity, robustness)
• Hands-on experience with biotechnology processes and principles
• Strong written and oral communication skills, including technical reporting
• Knowledge of statistical analysis methods
• Ability to handle and document sensitive and confidential information appropriately
• Strong understanding of laboratory safety, documentation practices, and operational requirements

Exposure to automation or high-throughput immunoassay platforms

• Paid Time Off & Holidays
• Medical, Dental, Vision (Multiple Plans Available)
• Basic Life (Company Paid) & Supplemental Life
• Short and Long Term Disability (Company Paid)
• Flexible Spending Accounts/Health Savings Accounts
• Paid Parental Leave
• 401(k) with company match
• Tuition/Continuing Education Reimbursement
• Life Assistance Program
• Pet Care Discounts