Microbiology Lab Technician

7 days ago

Aliso Viejo, California, United States Terumo Neuro Full time $60,000 - $90,000 per year

Job Description
Lead all laboratory activities and functions within the Microbiology Laboratory. Main responsibility consists of the testing of the routine external PCDs (Product Challenge Devices) used for the in-house steam and ethylene oxide sterilization processes, including the generation of any applicable test method and other related documents needed for the laboratory and any associated testing, IQ/OQ of all laboratory equipment, and routine monitoring of all temperature-controlled incubators and refrigerator. Take a proactive role in supporting the manufacturing team, provide internal customer support, and build a high level of trust with internal customers and MV personnel. Support any non-conformance investigation activities. Job duties:

  • Responsible for routine finished product sterility testing of steam and ethylene oxide external PCDs, including the tracking status of all testing within the laboratory.
  • Must interpret and apply specifications and test procedures when carrying out monitoring and testing responsibilities.
  • Responsible for the general cleanliness and appearance of the Micro Lab by keeping laboratory equipment, supplies, and overall environment in good operational status.
  • May prepare media reagents, testing materials, and equipment as required.
  • Responsible for ordering and maintaining materials, and supplies.
  • Record data in controlled company forms, validated spreadsheets, and build records.
  • May be required to work on special projects such as investigations and non-routine testing.
  • Maintain neat and legible records.
  • Follow cGMPs, GLPs, SOPs, USP, and FDA guidelines in all appropriate functions and notify management of any observed discrepancies in laboratory.
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
  • Perform additional duties as assigned.

Qualifications

  • HS diploma or equivalent.
  • M inimum five (5) years of related work experience.
  • S trong computer skills including MS Word, Excel, Teams, Outlook, etc.
  • Good written and verbal communication skills.
  • Ability to read, write, and speak in English.
  • Good laboratory or manufacturing practices and ability to follow required safety procedures.
  • Strong background and understanding of aseptic laboratory practices.
  • Good laboratory or manufacturing practices and ability to follow required safety procedures.
  • Experience with reading and preparing technical documentation.
  • Flexible to work nights and weekends, if necessary.

Desired Qualifications

  • Ability to analyze, investigate, and help solve technical issues involving steam and/or ethylene oxide sterilization and related equipment.
  • Ability to work independently and work efficiently in a fast-paced environment with shifting priorities.
  • Excellent time management, prioritization, and organizational skills.
  • Ability to promote effective working relationships at all levels, create a positive work environment, and collaborate with others in a team-based environment.
  • Excellent attention to detail.
  • Experience with steam or ethylene oxide sterilizers.
  • Re lated experience with working and handling biological indicators.
  • Experience in the medical device industry.

Posting Country
US - United States

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