Sr. Lab Technician

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation;

one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions:
Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone  work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

The Senior Lab Technician is a position within the Laboratory Operations group at TMC Elkton, which is comprised of both 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. Additionally, the Senior Lab Technician is responsible for data review and trending, investigation support activities, test instrument calibrations and maintenance, and supporting training activities.

This position will either be Chemistry-focused or Microbiology-focused, and the position will report directly to the Chemistry Manager or Microbiology Manager, accordingly.

• General Requirements:
  • Associate is responsible for following requirements of applicable national and international regulations.
  • Maintains awareness, training and knowledge of Terumo Safety Policies and Procedures to assure compliance with regulatory, global and site quality requirements.
  • Can work independently, with minimal guidance and supervision.
  • Maintains correct documentation of test results; practices Good Documentation Practices (GDP).
  • Correctly interprets test results and escalates excursions and out of specification results.
  • 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.
  • Performs pH and conductivity testing.
  • Supports sterilization dunnage preparation and maintenance activities.
  • Supports and performs instrument calibrations, checks, and maintenance.
  • Initiates and supports laboratory investigations, out of limit investigations, and non-conformances.
  • Conducts necessary project work/studies as assigned by management.
  • Supports training activities, including providing training to other technicians/associates.
  • Performs other job-related duties assigned.
• Performs inherent viscosity (IV) 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.
• Responsible for additive preparation function, including preparing product coatings and chemical analysis testing for direct production support (e.g., density, viscosity, gravimetric, etc.).
• Prepares samples for analytical testing (e.g., dilutions, extractions); prepares reference standards.
• Data review and approval of coating mixing records and routine testing records.
• Microbiology-Focused Responsibilities:
  • Performs quality control testing of microbiological media (pH, sterility, growth promotion).
  • Performs environmental monitoring (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…