Quality Control Specialist I - Mon-Fri 4:30 PM to 1 AM

Job description

The Position

Position Title:                   

Quality Control Specialist I         

Department Name:        

Quality Control

Reports To:        

Associate Supervisor, Quality Control

FLSA Status:                       

Non- Exempt

Shift / Schedule:              

2nd Shift / Mon-Fri 4:30 PM to 1 AM 

POSITION SUMMARY

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-Conformances, 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.

POSITION REQUIREMENTS

• 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

Education and Experience 

• B.S. degree required, in basic sciences, life sciences, or engineering. 
• 1 - 3 years of relevant experience

Skills – Technical

• 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

CERTIFICATIONS, LICENSES, REGISTRATIONS (if applicable)

• None

SUPERVISORY RESPONSIBILITIES (if applicable)

• None

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate.  This position may involve a combination of office and biotechnology laboratory environments.   The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear.  The employee is frequently required to stand and walk.  The employee may sometimes be required to lift and/or move up to 35 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

The expected salary range for this position based on the primary location of California is $41,600.00 - $77,200.00. 

Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are not available for this job posting.

Who we are

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare.  As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses.  GenMark’s ePlex true sample-to-answer system 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 true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.