What are the responsibilities and job description for the Quality Control Specialist I position at GenMark Diagnostics?
Heroes work here!
Do you want to join a company where you can be a hero too?
We deliver innovative, diagnostic solutions that improve the lives of patients and their families and are proud to be one of the heroic diagnostic companies that is in this fight against COVID-19.
As a member of GenMark’s team, you’ll get to be part of an organization where we embody our cultural beliefs in everything we do. The following is a glimpse of what our culture looks like and If you'd like to join us, we encourage you to apply as our company is growing!
- Go Big - We never settle and challenge what’s possible
- Win Together - We are one team with a shared purpose
- Own It - We step up, drive it, and deliver it
- Be Bold - We empower ourselves and others
Beginning November 15, 2021, GenMark Diagnostics requires all new hires to be fully vaccinated against COVID-19 as of their start date.
WHAT YOU'LL DO AT GENMARK!
This position conducts incoming, in-process and final release QC testing in a controlled manufacturing environment. This position may also execute validation studies, execute test protocols, analyze data, generate analytical reports, investigate Non-Conformance's, evaluate processes & procedures, utilize statistical techniques, review specifications, and inspect & test equipment. May conduct training on quality related tools, methods, and procedures. Interfaces with R&D, Manufacturing, Quality, and Supply Chain within the company and when appropriate with customers and suppliers on quality related issues.
~ Shift Schedule: Monday - Friday ( 3:00 pm - 11:30 pm) ~
- Follows cGMP and ISO standards or guidelines as they apply to manufacturing
- Completes batch records while maintaining good documentation practices
- Prepares/formulates QC test solutions following standard operating procedures and guidelines given by supervisor; solutions include aqueous solutions containing salts, organics, acids, bases and/or modified DNA and organic solutions
- Conducts QC testing following standard operating procedures and guidelines given by supervisor
- Under direction, perform validation and stability studies, execute protocols, analyze data, generate reports, initiate non-conformances for MRB
- Responsible for on-time completion of scheduled work orders
- Monitors inventory levels on a daily basis
- Participates in departmental projects—works with QC members on OOS/NCR/CAPA investigations as needed
- Understanding of molecular techniques (DNA extraction, PCR Amplification)
- Adheres to the requirements of working in a GMP, ISO certified or FDA workplace
- Assists with special projects as requested and perform additional duties as required
KEY QUALIFICATIONS
- B.S. degree required, in basic sciences, life sciences, or engineering and/or two (2) years of relevant experience in a QC capacity
- Technical knowledge of molecular biology, including principles of nucleic acid hybridization, probe and primer design, and enzymatic amplification of specific gene sequences
- Knowledge of safety precautions required for working with biohazards and bloodborne pathogens
- Knowledge of the Quality System; able to execute change orders under the guidance of higher level employees
- Knowledge of basic statistics relevant to interpretation and analysis of scientific data
ABOUT GENMARK
GenMark’s ePlex true sample-to-answer system symbolizes the evolution of eSensor technology combined with digital microfluidics. ePlex offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report, and is the only true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency.
GenMark is headquartered in Carlsbad, California