Advanced Quality Control Analyst

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range:

$55,600.00 - $91,450.00

Position Summary: 

This position is responsible for the setup, maintenance, and performance monitoring of hematology analyzers used in the evaluation of control products. This role performs routine and advanced troubleshooting, ensures consistent instrument performance, and supports daily laboratory operations. The analyst partners closely with the Bottling Department to monitor homogeneity testing during product bottling and verifies labels, assay documentation, and batch records for accuracy and compliance.

In addition, the position conducts analytical testing to confirm that products meet all applicable regulatory requirements and internal quality standards. The analyst serves as a technical resource for the Scientific Support team by assisting in the resolution of customer inquiries and product-related complaints. This role also supports QC Laboratory management with product release activities, procedure development, instrument validations, and other quality initiatives.

Key Responsibilities: 

• Perform and interpret laboratory homogeneity testing on products during the bottling process.
• Proofread and verify documents, labels, assay sheets, and related quality records for accuracy and compliance.
• Perform manual differential counts and execute kit testing for hematology products.
• Evaluate analytical data for accuracy, acceptability, and consistency with laboratory protocols and established statistical parameters.
• Calibrate hematology analyzers in accordance with Standard Operating Procedures (SOPs) and manufacturer guidelines.
• Work independently and collaboratively with minimal supervision to complete routine and project-based tasks.
• Maintain inventory levels and order reagents and consumables for assigned analyzers.
• Analyze data and assign internal control values for new lots of hematology products for designated instruments; routinely review and update instrument SOPs as needed.
• Participate in the training and onboarding of new employees.
• Update, revise, and/or author SOPs in accordance with quality and regulatory standards.
• Train in and perform specialized procedures or new method implementations to support laboratory operations.
• Follow universal precautions while handling hazardous materials, biohazardous specimens, and waste.
• Manage multiple tasks and projects effectively while maintaining accuracy and efficiency.
• Maintain a clean, organized, and compliant laboratory environment, including proper disposal of biohazard materials.
• Support and collaborate with cross-functional departments throughout the manufacturing process while adhering to cGLP, cGMP, cGDP, and ISO requirements.
• Follow company policies and practices as outlined in the Employee Handbook and comply with all safety guidelines, including OSHA, AWAIR, Chemical Hygiene, and Exposure Control standards.
• Perform additional duties as assigned.

QUALIFICATIONS

Education and Experience:

• MLT or MLS certification, or a bachelor’s degree in a scientific discipline or equivalent combination of education and relevant laboratory experience.
• Hematology laboratory experience preferred.