Lab Technician II

Job Summary

The Lab Technician II is a position within the Laboratory Operations group at TMC Elkton, which is comprised of both the Chemistry and Microbiology teams.  This role is responsible for general laboratory duties and for performing a variety of sampling, testing, and assays based on the specific functions of the Chemistry and/or Microbiology team within Laboratory Operations.  
This position will either be Chemistry-focused or Microbiology-focused, and the position will report directly to the Chemistry Manager or Microbiology Manager, accordingly.

Job Details/Responsibilities

General Laboratory Support:

• Maintains awareness, training and knowledge of Terumo Safety Policies and Procedures to assure compliance with regulatory, global and site quality requirements.
• Completes data entry into designated files or databases.
• Completes document archiving and retention activities.
• Performs routine laboratory housekeeping activities, such as waste removal, laboratory cleaning, glassware maintenance, general organizing, etc.  
• Conducts laboratory supply inventory checks and submits purchase requisitions to restock materials, chemicals, and reagents as needed.
• Supports sterilization dunnage preparation and maintenance activities.

General Assay/Test Execution:

• Maintains correct documentation of test results; practices Good Documentation Practices (GDP).
• Correctly interprets test results and escalates excursions and out of specification results.
• Initiates and supports laboratory investigations and non-conformances.
• Performs pH and conductivity testing.
• Conducts necessary project work/studies as assigned by management.

Chemistry-Focused Role:

• Performs product particulate testing.
• Performs inherent viscosity (IV) testing.
• Performs moisture testing.
• Supports cleaning validation process monitoring program; activities include sample reconciliation, sample submission/tracking, and data review
• Performs incoming inspection of chemicals and resins used in manufacturing.  Responsibilities include inspecting materials in the warehouse, physical material release, and electronic material release in SAP/MHCS systems.

Job Responsibilities (continued)

Microbiology-Focused Role:

• Performs quality control testing of microbiological media (pH, sterility, growth promotion).
• Performs environmental monitoring of controlled environments (non-viable particulate, viable air, and viable surface).
• Performs process water sampling and testing (bioburden, endotoxin, TOC, and conductivity).
• Completes sample preparation activities, such as device disassembly and cutting, using aseptic technique.
• Performs plate counting and microbial characterization/Gram staining.
• Performs product bioburden testing and bacterial endotoxins testing (BET/LAL).
   

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Effective written and verbal communication skills.
• Demonstrated logical thought processes and decision-making ability.
• Quality consciousness in the ability to recognize and correctly respond to deviations from standard conditions and or procedures.
• The ability to prioritize work and maintain focus on the task at hand.
• Demonstrated involvement in actively improving Laboratory Operations processes and efficiency.
• Ability to make product disposition choices based on quality criteria, test result conformance to specifications, and product requirements.   
   

Qualifications/ Background Experiences

• High school diploma (or equivalent), coupled with a minimum of 5 years of relevant experience in a chemistry and/or microbiology laboratory setting.
• Associate’s degree in biology, chemistry or related science preferred, coupled with a minimum of 2 years of relevant experience in a chemistry and/or microbiology laboratory setting.
• Bachelor’s degree preferred in biology, chemistry, microbiology and or related science with 0 – 2 years’ experience in chemistry and/or microbiology laboratory setting; experience with aseptic technique and/or chemistry lab instrumentation strongly preferred.