Manufacturing Quality Control Technician

Company: Genalyte, Inc.
Location: San Diego
Posted on: May 16, 2022

Job Description:

Since 2007, Genalyte has been guided by a vision: to positively impact human health by disrupting conventional diagnostic techniques. Genalyte is disrupting the lab testing world by moving lab testing from the research lab into the physician's office.

We are well funded with outstanding growth potential. We are looking for individuals inspired by our technology and vision, who are eager to be at the ground level of this collaborative and entrepreneurial company.

We want to hire individuals who are interested in creating an innovative, fast-paced and dynamic work setting. We offer a competitive salary and benefits package to attract, motivate, and retain the highest caliber of employee.

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.

Principal Responsibilities

• Operates laboratory equipment safely, adheres and complies to all company safety guidelines and practices.
• Quality Control testing of manufactured consumables, intermediaries, and R&D testing activities utilizing various instruments.
• Performs specialized tasks as trained in an independent fashion, requiring minimal ongoing direction, such as biotinylation, titration, dilutions, assays, and other lab activities.
• Gathers, analyzes, and completes testing data reports.
• Supports bulk formulations, reagent prep, and other lab activities and tasks.
• 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.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results. Routinely operates to QSR, GMP, GLP, ISO, and safety guidelines.
• 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.
• Demonstrate a commitment to the development, implementation and effectiveness of Genalyte's Quality Management System per ISO, FDA and other regulatory agencies.
• 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.
• Cover on-call assignments as assigned.
• Other responsibilities as assigned.
  
  Qualifications
  
  • BA/BS in Chemistry or Biological Sciences or 2-5 years of relevant experience in biotech, medical device, diagnostics or related field performing production processes, buffer formulations that contain biologics, Quality Control of buffers and biological materials.
  • Demonstrated skills in executing manufacturing operations with minimal guidance in an accurate, effective manner.
  • 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
    
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Keywords: Genalyte, Inc., San Diego , Manufacturing Quality Control Technician, Professions , San Diego, California