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 minimal supervision, this position is responsible for supporting in-process, intermediates, and final release testing utilizing various types of instruments and assisting manufacturing and team members in carrying out simple to complex manufacturing processes and tasks involving a variety of laboratory methods, equipment and procedures. This position is a temporary position with the possibility of conversion

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to: 

• Operates laboratory equipment safely, adheres and complies to all company safety guidelines and practices

• Demonstrate a commitment to the development, implementation and effectiveness of Genalyte's Quality Management System per ISO, FDA and other regulatory agencies
• Quality Control testing of manufactured consumables, intermediaries, and R&D testing activities utilizing various instruments
• Independently performs specialized tasks as trained, such as bulk formulations, reagent prep, biotinylation, titration, dilutions, assays, and other lab activities
• Responsible for preparing and performing technical experiments that involve the use of micropipettes, lab instruments, and wet lab techniques. Gathers, analyzes, and completes testing data reports
• Maintain records of laboratory activities and notebooks in a professional, accurate manner as per QSR, GMP and ISO guidelines
• Support consumables manufacturing in various processes and activities to include manual, semi-automated, and fully automated assembly
• Draft and revise documents including SOP's, MRP's, specifications and in-process or release testing protocols
• Collaborate with supervisor to establish objectives, milestones, and timelines for completion. Report progress and results to Supervisor on a regular basis
• Generate formal and informal reports of experimental data and results through analysis and summary. Communicate and present these results individually and in meetings
• Establish and maintain lines of communication to ensure the timely and accurate flow of information and regularly interact with all departments, including but not limited to representatives from Engineering, Quality, Production Planning, Purchasing, Finance/Accounting and R&D
• Participate in new product/process transfers. Collaborate with R&D, Tech Transfer, Engineering, Quality and any other department as appropriate to establish transfer timelines consistent with milestone due dates
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job
• Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing in-process and release testing activities
• Other responsibilities as assigned

ADDITIONAL FUNCTIONS & RESPONSIBILITIES 

• Train, coach and mentor junior team members as appropriate and/or directed by supervisor
• Able to work with a variety of people on multiple tasks
• Knowledge of a variety of lab equipment and their operation is preferred
• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
• Demonstrate problem-solving and troubleshooting skills
• Strong verbal and written communication skills
• Organized and detail oriented
• Knowledge and ability to use MS Office, inventory control and other manufacturing systems
• Ability to work in a team environment

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• BA/BS in Chemistry or Biological Sciences or 2 years minimum  hands-on job experience in biotech, medical device, diagnostics or related field performing buffer formulations that contain biologics, Quality Control of buffers and biological materials, or QC Testing
• Demonstrated skills in executing manufacturing operations with minimal guidance in an accurate, effective manner
• Able to work with a variety of people on multiple tasks
• Knowledge of a variety of lab equipment and their operation is preferred
• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
• Demonstrate problem-solving and troubleshooting skills
• Strong verbal and written communication skills
• Organized and detail oriented
• Knowledge and ability to use MS Office, inventory control and other manufacturing systems
• Ability to work in a team environment

The base range for this role is $25-$28 per hour. Individual pay may vary based on additional factors, including but not limited to, job-related skills, experience, work location, and relevant education or training.