Advanced Quality Control Analyst
Bio-Techne
2 hours ago
On-site
Minneapolis, MN
Operations
Position Summary
- Setup, maintenance, and performance monitoring of hematology analyzers used to evaluate control products. Perform routine and advanced troubleshooting, ensure consistent instrument performance, and support daily laboratory operations.
- Partner with the Bottling Department to monitor homogeneity testing during product bottling and verify labels, assay documentation, and batch records for accuracy and compliance.
- Conduct analytical testing to confirm products meet regulatory requirements and internal quality standards.
- Serve as a technical resource for the Scientific Support team by assisting with customer inquiries and product-related complaints.
- Support QC Laboratory management with product release activities, procedure development, instrument validations, and other quality initiatives.
Key Responsibilities
- Perform and interpret laboratory homogeneity testing 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 per SOPs and manufacturer guidelines.
- Work independently and collaboratively with minimal supervision.
- Maintain inventory levels; order reagents and consumables for assigned analyzers.
- Analyze data; assign internal control values for new lots; review and update instrument SOPs as needed.
- Participate in training and onboarding of new employees.
- Update, revise, and/or author SOPs to meet quality and regulatory standards.
- Train in and perform specialized procedures/new method implementations.
- Follow universal precautions for hazardous materials, biohazardous specimens, and waste.
- Manage multiple tasks/projects while maintaining accuracy and efficiency.
- Maintain a clean, organized, compliant lab environment, including proper disposal of biohazard materials.
- Support cross-functional departments during manufacturing while adhering to cGLP, cGMP, cGDP, and ISO requirements.
- Follow safety guidelines (OSHA, AWAIR, Chemical Hygiene, Exposure Control) and comply with company policies.
- Perform additional duties as assigned.
Qualifications
- 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.
Benefits (explicitly listed)
- Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
- 401k, ESPP, HSA, FSA, and Dependent Care FSA.
Application Instructions
- Submit a candidate application (unsolicited resumes not accepted from other sources).
- Setup, maintenance, and performance monitoring of hematology analyzers used to evaluate control products. Perform routine and advanced troubleshooting, ensure consistent instrument performance, and support daily laboratory operations.
- Partner with the Bottling Department to monitor homogeneity testing during product bottling and verify labels, assay documentation, and batch records for accuracy and compliance.
- Conduct analytical testing to confirm products meet regulatory requirements and internal quality standards.
- Serve as a technical resource for the Scientific Support team by assisting with customer inquiries and product-related complaints.
- Support QC Laboratory management with product release activities, procedure development, instrument validations, and other quality initiatives.
Key Responsibilities
- Perform and interpret laboratory homogeneity testing 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 per SOPs and manufacturer guidelines.
- Work independently and collaboratively with minimal supervision.
- Maintain inventory levels; order reagents and consumables for assigned analyzers.
- Analyze data; assign internal control values for new lots; review and update instrument SOPs as needed.
- Participate in training and onboarding of new employees.
- Update, revise, and/or author SOPs to meet quality and regulatory standards.
- Train in and perform specialized procedures/new method implementations.
- Follow universal precautions for hazardous materials, biohazardous specimens, and waste.
- Manage multiple tasks/projects while maintaining accuracy and efficiency.
- Maintain a clean, organized, compliant lab environment, including proper disposal of biohazard materials.
- Support cross-functional departments during manufacturing while adhering to cGLP, cGMP, cGDP, and ISO requirements.
- Follow safety guidelines (OSHA, AWAIR, Chemical Hygiene, Exposure Control) and comply with company policies.
- Perform additional duties as assigned.
Qualifications
- 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.
Benefits (explicitly listed)
- Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
- 401k, ESPP, HSA, FSA, and Dependent Care FSA.
Application Instructions
- Submit a candidate application (unsolicited resumes not accepted from other sources).