Microbiology Lab Technician
Kelly Outsourcing Consulting Group Kelly OCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Microbiology Lab Technician for a 1-year engagement at one of our Global medical device clients in Irvine, CA. This role is a full-time, fully benefited position. As a Kelly OCG employee, you will be eligible for Medical, Dental, 401K and paid time off, including holiday, vacation and sick/personal time.

Duration: 1-year, potential to extend
Irvine, CA
Monday – Friday, 1^st shift (exact hours flexible)
Compensation is $25-35/hr

SUMMARY

• Under general supervision conducts testing and test sampling of the clean rooms, compressed air, and microbiological quality test samples. Also, functions in the execution of more complex laboratory activities in the Microbiology Lab such as study support for sterilization validation and biocompatibility programs.

RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines, this position:

• Performs in a competent manner, after training, routine tests by following the laboratory procedures and test methods.
  

• Develops a competence after training of the use of laboratory instruments and equipment.
  

• Works in compliance with the current manufacturing good practices (GMPs) and of laboratories (GLPs) in regards of documentation, tests and maintenance, notebooks and data sheets, in a precise manner.
  

• Initiation and participation of Laboratory Research of non-conforming laboratory tests results.
  

• Collects and prepares laboratory records for evaluation following documentation good practices.
  

• Performs   other   tasks   related   to   the   laboratory   that   are   assigned   by   the management.
  

• Provides support to internal, environmental and safety laboratory management.
  

• Responsible for communicating business related issues or opportunities to next management level
  

• Environmental Microbiological testing of clean rooms (particulates, viable air and surfaces).
  

• Microbiological testing of  clean  compressed  air (oil mist, water vapor, viable air and particulates).
  

• Product bioburden testing.
  

• Product endotoxin testing.
  

• Biological Indicator (BI) testing.
  

• Organize and present all testing performed (if applicable) within the microbiology lab to senior team members for review.
  

• Review sterilization lot records (i.e., cycle run records, contract lab test reports, BI placement form), organize documents and submit (if applicable) to senior Microbiological Quality and Sterility Assurance team members for final review.
  

• Prepare and ship product or test samples to contract testing labs as required.
  

• Keep the senior team members appraised on the status of supplies in the microbiological laboratory. In addition, notify Microbiological Quality and Sterility Assurance leadership of faulty or damaged testing equipment. Interacts directly with vendors of supplies and equipment.
  

• Assist the with validation or special projects as required.
  

• Generate nonconformances (NCR’s) and assist, as directed, in the investigation of NCR’s. Complete NCR follow-up testing documentation for review of Microbiological Quality and Sterility Assurance leadership.
  

• Provide input to Microbiological Quality and Sterility Assurance leadership for process improvement ideas related to the testing of clean rooms, support systems and product.
  

• Performs other duties assigned as needed.

EXPERIENCE AND EDUCATION

• 0-2 years of experience with good knowledge of company operations, quality standards and GMP regulations of a medical device or pharmaceutical company;
  

• BS Degree in a biological science, biochemistry, chemistry, physical science or a related field of study is preferred.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Possess broad understanding of the English language and show the ability for oral and written communication in that language.
  

• Demonstrated knowledge of manufacturing principles and practices, and procedures
  

• Knowledge of specific business practices and software and software applications
  

• Able to enter data on spread sheet and database applications
  

• Ability to communicate effectively with a diverse supplier/vendor base
  

• Ability to work cooperatively with coworkers and the public
  

• Preferred experience maintaining laboratory ordering and inventory
  

• Preferred experience in the Medical Device industry or medical field
  

• Preferred experience in conducting Product endotoxin testing (LAL)
  

• Preferred experience in conducting Environmental Monitoring testing of environmentally controlled environments
  

• Preferred experience in conducting Growth Promotion testing and Medial Stability studies
  

• Able to work overtime or weekend work (as needed).
  

• Ability to work in a special environment such as a clean room.
  

• Ability to wear protective garb such as lab or clean room gowns

What happens next
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about,
#P1

Send resumes to Jacqueline.Sayoc@KellyScientific.com
 

9731506