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
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