Sr. Lab Technician

Terumo•Elkton, MD

16d

About The Position

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.

Requirements

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.
Demonstrated ability to perform laboratory tests with technical proficiency.
Experience in guiding the work of others and providing training to team members.
High school diploma (or equivalent), coupled with a minimum of 8 years of relevant experience in a chemistry and/or microbiology laboratory setting.

Nice To Haves

Associate’s degree in biology, chemistry or related science preferred, coupled with a minimum of 4 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 2 – 4 years’ experience in chemistry and/or microbiology laboratory setting; experience with aseptic technique and/or chemistry lab instrumentation strongly preferred.

Responsibilities

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 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.
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.
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 staining.
Performs product bioburden testing and bacterial endotoxins testing (BET/LAL).
Completes data trending and analysis; supports trending reports to support contamination control program.