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Sr. Lab Technician

Date Posted: 2/18/2019

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Job Description

We are seeking a Sr. Lab Technician to join a global medical device company in Irvine, CA! This is a one year long position and a great opportunity to join a growing enterprise!


Job Purpose:


·         The Sr Lab Technician will provide testing services in a laboratory environment


Essential Job Functions:


·         Perform routine and non-routine testing services using established procedures/protocols (e.g D-value, B&F, FETS, glut, TLS, antimicrobial, sterility, receive, inspect, in process solutions, etc)


·         Collect environmental lab samples from multiple clean rooms


·         Perform data entry of routine and non-routine testing


·         Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records


·         Assist in testing validation/revalidation activities for critical systems and equipment under close supervision


·         Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations


·         May maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule


·         Initiate and support laboratory investigations and propose recommendations for manager view


·         Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data


·         Execute equipment and process validation protocols


·         Assess and qualify new equipment


·         May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures


·         Other incidental duties


Skills:


·         Able to read, comprehend, write and speak English


·         Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g., ChemStation, Empower) preferred


·         Full knowledge of laboratory processes


·         Full knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations


·         Full knowledge in mathematics, e.g., decimals and percentages


·         Ability to write technical documents


·         Strong knowledge with ISO microbiological sterilization documents if applicable


·         Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing


·         Strict attention to detail


·         Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment


·         Must be able to work in an inter-departmental team environment, as well as with colleagues from other departments


·         Ability to provide feedback in a professional, direct, and tactful manner


·         Ability to represent the organization to outside contacts, i.e., vendors


Education & Experience:


·         Bachelor's Degree in Chemistry and or Microbiology preferred
 

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, includ

Job Requirements

We are seeking a Sr. Lab Technician to join a global medical device company in Irvine, CA! This is a one year long position and a great opportunity to join a growing enterprise!

Job Purpose:

·         The Sr Lab Technician will provide testing services in a laboratory environment

Essential Job Functions:

·         Perform routine and non-routine testing services using established procedures/protocols (e.g D-value, B&F, FETS, glut, TLS, antimicrobial, sterility, receive, inspect, in process solutions, etc)

·         Collect environmental lab samples from multiple clean rooms

·         Perform data entry of routine and non-routine testing

·         Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records

·         Assist in testing validation/revalidation activities for critical systems and equipment under close supervision

·         Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations

·         May maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule

·         Initiate and support laboratory investigations and propose recommendations for manager view

·         Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data

·         Execute equipment and process validation protocols

·         Assess and qualify new equipment

·         May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures

·         Other incidental duties

Skills:

·         Able to read, comprehend, write and speak English

·         Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g., ChemStation, Empower) preferred

·         Full knowledge of laboratory processes

·         Full knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations

·         Full knowledge in mathematics, e.g., decimals and percentages

·         Ability to write technical documents

·         Strong knowledge with ISO microbiological sterilization documents if applicable

·         Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

·         Strict attention to detail

·         Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment

·         Must be able to work in an inter-departmental team environment, as well as with colleagues from other departments

·         Ability to provide feedback in a professional, direct, and tactful manner

·         Ability to represent the organization to outside contacts, i.e., vendors

Education & Experience:

·         Bachelor's Degree in Chemistry and or Microbiology preferred
Posted By: jarthur@ultimatestaffing.com

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Job Snapshot

  • Employee Type:Full-Time
  • Location:Irvine, CA
  • Job Type:Science
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:2/18/2019
  • Contact: Julia Arthur (949) 265-6070
  • Pay Range: $27.00 - $31.00 Hourly
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Job Reference: JO-1902-51075