Technologist I

Perform moderate to high complexity laboratory testing procedures and manufacture blood products according to FDA, AABB, CLIA and Red Cross policies. Ensure quality and quantity production goals are met and products are suitable for release. Operate and maintain laboratory equipment and perform quality control on products and reagents.

Responsibilities

• Perform moderate to high complexity laboratory testing procedures and manufacture blood products according to FDA, AABB, CLIA and Red Cross policies and procedures.
• Meet the quality and quantity production and testing goals established by the department.
• Ensure products are suitable for release for distribution and appropriately manage any exceptions.
• Perform good inventory management practices throughout the manufacturing process.
• Prioritize workload to meet production and customer requirements.
• Perform quality control on products, reagents, equipment, and various test kits.
• Perform and interpret various testing procedures on donor specimens and blood products.
• Track quantities and results of QC testing to meet ARC and regulatory requirements.
• Operate, maintain, repair and perform validation and quality control checks on laboratory equipment, reagents and supplies.
• Participate in qualifications and validations for collections equipment.
• Ensure adequate inventory of required supplies.
• Perform data entry and operate computer programs associated with component production, labeling and testing.
• Maintain accurate, legible and complete manufacturing department records.
• Maintain accurate electronic and physical inventory locations for products/samples.
• Perform review of manufacturing records.
• Participate in troubleshooting and problem-solving activities with cross-functional teams.
• Analyze and make decisions based on visual inspection and information from other departments to meet time requirements and quality standards.
• Identify and quarantine products/samples that don’t meet quality requirements.
• Participate in QC staff training as needed.

Requirements

• Associates degree in science required, MLT (ASCP) or MT(ASCP) certification preferred.
• No additional experience required for MLT or MT degreed staff.
• Minimum 4 years of related experience in a regulatory, laboratory, or manufacturing environment or equivalent combination of education and related experience required for non-MLT/MT staff.
• Must meet state and CLIA requirements.
• Ability to use a wide variety of lab or medical equipment.
• Ability to use a personal computer and applicable software for sustained periods of time.
• Ability to work with a team.

Skills

• MLT(ASCP) certification
• MT Certification
• Regulatory Compliance
• Laboratory Testing
• Manufacturing Blood Products
• FDA Regulations
• AABB Standards
• CLIA Requirements
• Laboratory Equipment Operation
• Quality Control
• Medical Equipment Use
• Laboratory Software Use
• Product Release Procedures
• Quality Assurance
• Laboratory Testing Procedures

Languages

English