ABOUT GENALYTE 

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.
 

POSITION SUMMARY
Under supervision, performs a variety of manufacturing functions including assembly and packaging of kits, reagent preparation, material management and inventory control and other duties in support of manufacturing and operations. Responsible for following SOPs, performing daily tasks in a clean room/GMP environment. May also be responsible for troubleshooting manufacturing product challenges.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to: 

• Perform all duties that are required to produce reagents, intermediate consumables and finished good kits. Duties include:
  • Manual manipulation of small components in the assembly of consumables items.
  • Manual and semi-automated liquid filling and QC verification of reagents into consumables.
  • Manual and semi-automated finished goods kitting.
  • Reagent formulation and use in the production environment including exposure to aqueous and organic hazardous materials such as acetone and isopropanol.
  • Material management which consists of timely transfer and replenishment of materials and/or supplies to point-of-use location.
  • Ensure inventory accuracy.
• Perform precision hand placement of small components.
• Notify area leadership or engineering of product discrepancies.
• Maintain or exceed acceptable productivity levels while maintaining a consistent and acceptable level of quality.
• Maintain a high level of cooperation and positive interaction with team members and peers.
• Accurately complete all documentation associated with manufacturing processes.
• Maintain compliance with all company policies, quality systems, and procedures.
• Train to cGMP, ISO 13485 and 21 CFR part 820 requirements and perform activities in compliance with them.
• Able to perform all tasks above following written procedures (including assembly drawings), filling out batch records and tracking intermediate and finished goods inventory for each task. Employ cleaning procedures, aseptic processing techniques, current Good Manufacturing Practices (cGMP), in a clean room with chemical and biological safety practices including exposure to dry environments and hazardous materials.
• Perform other duties as assigned by area leadership.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• High School education or completion of GED with a minimum of 3 years experience in an FDA regulated environment with basic laboratory operations principles such as PPE, handling of refrigerated or frozen biological materials, handling chemically and/or biologically hazardous materials and basic laboratory equipment (an equivalent combination of experience and education may be considered).
• Experience working with biological testing is a plus.
• Proficient in general hand and small tools, such as tweezers.
• Demonstrated good hand-eye coordination.
• Ability to apply common sense understanding to carry out detailed but involved written or oral instructions.
• Previous experience with pipetting and filling of well-plate preferred.
• Proficient computer skills and good working knowledge of Microsoft Office programs (Word, Excel, Access).
• Ability to perform basic math and calculations using weight measurement, volume, and distance governed by Quality documents and Standard Operating Procedures.
• Ability to demonstrate exceptional attention to detail.
• Good oral communication skills and proficiency in English (verbal and written).
• Ability to work overtime as required.