Quality Control Specialist I

Quality Control Carlsbad, California


Description

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.

Essential Duties and Responsibilities

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:

  • S. degree required, in basic sciences, life sciences, or engineering and/or three (3) years of relevant experience in a QC capacity

 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

Skills - General

  • Ability to handle and resolve conflicts and work under schedule/milestone pressures
  • Demonstrated ability to be flexible and resourceful
  • Good communication, technical writing, and diplomacy skills
  • Ability to work in a multi-functional team environment
  • Organizational, planning and detailed follow-up skills required

 

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 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

GenMark Dx does not accept agency submittals. Please do not forward resumes to our Executive team, Management team, or any current GenMark employee for review. GenMark Dx is not responsible for any fees related to unsolicited resumes.

GenMark is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of any kind: GenMark is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at GenMark are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. GenMark will not tolerate discrimination or harassment based on any of these characteristics. GenMark encourages applicants of all ages. GenMark participates in E-Verify. GenMark is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.