QC Supervisor

Antech

2d

About The Position

The QC Supervisor is responsible for leading Quality Control immunoassay testing activities in a regulated biotech environment. This role oversees QC execution, data review, and team performance to ensure accurate, compliant, and timely release of materials and products. The QC Supervisor serves as a technical and people leader, supporting product lifecycle activities and maintaining high standards of data integrity and quality.

Requirements

• 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.

Nice To Haves

• Exposure to automation or high-throughput immunoassay platforms (preferred).

Responsibilities

• 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

Benefits

• 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

What This Job Offers

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