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 at Terumo. We 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.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary:

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.

Job Details:

1. General Requirements:
   1. Associate is responsible for following requirements of applicable national and international regulations.
   2. Maintains awareness, training and knowledge of Terumo Safety Policies and Procedures to assure compliance with regulatory, global and site quality requirements.
   3. Can work independently, with minimal guidance and supervision.
   4. Maintains correct documentation of test results; practices Good Documentation Practices (GDP).
   5. Correctly interprets test results and escalates excursions and out of specification results.
   6. Completes data entry into designated files or databases. 
   7. Completes document archiving and retention activities.
   8. Performs routine laboratory housekeeping activities, such as waste removal, laboratory cleaning, glassware maintenance, general organizing, etc. 
   9. Conducts laboratory supply inventory checks and submits purchase requisitions to restock materials, chemicals, and reagents as needed.
   10. Performs pH and conductivity testing.
   11. Supports sterilization dunnage preparation and maintenance activities.
   12. Supports and performs instrument calibrations, checks, and maintenance. 
   13. Initiates and supports laboratory investigations, out of limit investigations, and non-conformances.
   14. Conducts necessary project work/studies as assigned by management.
   15. Supports training activities, including providing training to other technicians/associates.
   16. Performs other job-related duties assigned.

2. Chemistry-Focused Responsibilities:
   1. Performs particulate testing.
   2. Performs inherent viscosity (IV) testing.
   3. Performs moisture testing.
   4. Supports cleaning validation process monitoring program; activities include sample reconciliation, sample submission/tracking, and data review.
   5. 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. 
   6. Responsible for additive preparation function, including preparing product coatings and chemical analysis testing for direct production support (e.g., density, viscosity, gravimetric, etc.).
   7. Prepares samples for analytical testing (e.g., dilutions, extractions); prepares reference standards.
   8. Data review and approval of coating mixing records and routine testing records.

3. Microbiology-Focused Responsibilities:
   1. Performs quality control testing of microbiological media (pH, sterility, growth promotion).
   2. Performs environmental monitoring (non-viable particulate, viable air, and viable surface).
   3. Performs process water sampling and testing (bioburden, endotoxin, TOC, and conductivity).
   4. Completes sample preparation activities, such as device disassembly and cutting, using aseptic technique. 
   5. Performs plate counting and microbial characterization/Gram staining.
   6. Performs product bioburden testing and bacterial endotoxins testing (BET/LAL).
   7. Completes data trending and analysis; supports trending reports to support contamination control program. 

Position Requirements:

Knowledge, Skills, and Abilities

• • 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.

Background Experience

• • High school diploma (or equivalent), coupled with a minimum of 8 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 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.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. 

We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Rate of pay:  $48,400-$66,500 annually