Manufacturing Lab Technician I - Temp

Genalyte•San Diego, CA

2d•$25 - $28

About The Position

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

Requirements

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

Nice To Haves

Knowledge of a variety of lab equipment and their operation is preferred

Responsibilities

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
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