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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Scientist 2

Regulatory & Quality (Life Sciences)Posted on Nov 11
Full-timeAthlone, Co. Westmeath, IrelandNo salary listed

About the Job

Requirements

  • A bachelor's degree or equivalent and relevant formal academic or vocational qualification is required.
  • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2 or more years, is required.
  • Demonstrated knowledge of multiple applicable techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), dissolution testing, inhalation testing, biopharmaceutical testing, Karl Fischer titration, ultraviolet-visible spectroscopy (UV-Vis), Fourier-transform infrared spectroscopy (FT-IR), and total organic carbon (TOC) is required.
  • Proficiency in Microsoft Excel and Word is required.
  • The ability to interpret data by performing trend analysis is required.
  • Technical writing skills are required.
  • The ability to independently optimize analytical methods is required.
  • Problem-solving and troubleshooting abilities are required.
  • Time management and project management skills are required.
  • The ability to work collaboratively with a team is required.
  • The role requires adherence to Good Manufacturing Practices (GMP) safety standards and work according to applicable standard operating procedures (SOPs), regulatory procedures and guidelines, protocols, methods, client criteria, and Good Laboratory Practices (GLP) or GMP.
  • The role requires the ability to work upright or stationary for 6–8 hours per day, perform repetitive hand movements to operate laboratory equipment, and occasionally crouch or stoop, with frequent bending and twisting of the upper body and neck.
  • The role requires light to moderate lifting and carrying, up to 15–20 pounds, and occasional mobility.
  • The role requires the ability to access and use in-house and off-the-shelf computer software.
  • The role requires the ability to communicate and understand information presented verbally, listen to others, and interact frequently with diverse groups to obtain or convey information.
  • The role requires working independently with little guidance, planning work schedules to meet goals, sustaining multiple periods of intense concentration, multitasking, and performing under stress amid changing demands.
  • The role requires regular and consistent attendance.
  • Personal protective equipment, including protective eyewear, garments, and gloves, is required.

Responsibilities

  • Perform complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing.
  • Work with multiple functional groups to meet business needs.
  • Plan and organize work with periodic supervision.
  • Set up and maintain analytical instrumentation.
  • Train in the routine operation, maintenance, and theory of analytical instrumentation, standard operating procedures, and regulatory procedures and guidelines.
  • Ensure quality assurance findings are addressed appropriately.
  • Provide assistance and training to other team members.
  • Troubleshoot extraction and instrumentation problems independently or with assistance.
  • Communicate project status to the project leader.
  • Perform work assignments accurately, promptly, and safely.
  • Review, interpret, and analyze data for technical quality and compliance with protocols, methods, standard operating procedures, client criteria, and Good Manufacturing Practices or Good Laboratory Practices.
  • Perform self and peer reviews of data for accuracy and compliance with reporting requirements before submission to quality assurance and issuance to customers.
  • Work in a laboratory and/or clinical environment with exposure to electrical office equipment, biological fluids and potential infectious organisms; there may be rare exposure to skin and lung irritants, radiation, toxic materials, hazardous waste, or fluctuating and extreme temperatures.
  • Occasionally drive to site locations and travel domestically.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size
10,001+
Company stage
IPO
Headquarters
Waltham, MA
Founded
1956

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