Hematology - Advanced Quality Technician

Role Summary

Setup, maintenance, monitoring of hematology analyzers, and troubleshooting. Perform homogeneity testing during bottling, verify labels and assay documentation, and test finished products to ensure compliance with applicable laws and company standards. Serve as a resource to the Scientific Support team to resolve customer inquiries and complaints. Assist the QC Laboratory Manager/Supervisor with releasing products to bottle and ship, writing procedures, and validating instruments.

Responsibilities

• Perform and interpret laboratory homogeneity testing on products during the bottling process.
• Proofread and verify documents, labels, and assay sheets.
• Perform manual counts and kit testing.
• Evaluate data for accuracy, acceptability, and consistency with established laboratory protocol and standard deviations.
• Calibrate analyzers according to Standard Operating Procedures (SOP).
• Work independently and as a team with minimal guidance on routine tasks.
• Maintain inventory and order reagents for assigned analyzers.
• Analyze data and assign internal control values for new lot of hematology products for specified instruments. Routinely check instrument SOP for necessary updates.
• Participate in training new employees.
• Ability to update and/or write SOPs to quality standards.
• Train on specialized procedures or implementations.
• Use universal precautions when handling hazardous materials and biohazard specimens and waste.
• Ability to work on multiple tasks and projects with effectiveness and efficiency.
• Ability to maintain a clean and organized laboratory environment, including disposal of biohazard materials.
• Support and collaborate with other departments at all stages of the manufacturing process, while following cGLP, cGMP, cGDP, and ISO protocols.
• Follow company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the OSHA safety regulations, AWAIR, Chemical Hygiene and Exposure Control manuals in accordance with the job.
• Perform additional duties as assigned.

Qualifications

• Required: Hematology laboratory experience.

Skills

• Knowledge of basic science laboratory equipment and ability to follow standard operating procedures.
• Working knowledge of Microsoft Office.
• Attention to details and accuracy.
• Ability to work 8-hour shift that conform to standard business operations and training schedule.
• Preferred: phlebotomy experience, or the ability to learn within 6 months.

Education

• MLT, or MLS, or bachelor's degree in science or equivalent of work/school experience in related field of study. Hematology laboratory experience required.