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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Quality Assurance Specialist (Product Compliance)

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeTokyo, JapanNo salary listed

About the Job

Requirements

  • Hold a master's degree or higher in a science-related field; biology is preferred.
  • Meet the qualification requirements for the Poisonous and Deleterious Substances Handling Supervisor credential.
  • Have knowledge of and experience handling the employer's research instruments and analytical reagents, or comparable products from another company.
  • Have at least three years of practical experience in product safety or chemical management at a manufacturer; candidates from any industry are eligible.
  • Be able to read and write official documents in Japanese and negotiate in Japanese.
  • Have English proficiency sufficient to read technical documents and write emails, and to participate in email and telephone meetings.

Responsibilities

  • Conduct quality assurance work for research instruments, including consumables, and research reagents.
  • As the regulatory compliance specialist for company products, check applicable regulations, including regulations for poisonous and deleterious substances and the Cartagena Protocol, particularly when introducing new products, and handle necessary government procedures.
  • Create statutory labels and Safety Data Sheets.
  • Respond to inquiries from customers and requests from internal and external stakeholders.
  • Research and manage database information on domestic product regulations applicable to company products, including the Industrial Safety and Health Act, Poisonous and Deleterious Substances Control Act, PRTR Act, Electrical Appliances and Materials Safety Act, Radio Act, and High Pressure Gas Safety Act.
  • Create and revise GHS labels and Safety Data Sheets.
  • Issue certificates.
  • Provide training and business support, and improve processes for regulatory compliance.
  • Manage regulated business operations, such as the import and sale of poisonous and deleterious substances, and maintain product controls and business permits as the Poisonous and Deleterious Substances Handling Supervisor.
  • Prepare training materials and deliver internal training.

Desired Qualifications

  • Knowledge of machinery safety and experience handling compliance with the Electrical Appliances and Materials Safety Act.
  • Experience as a team leader or in team management; people-management experience is not required.
  • Experience using ERP systems such as SAP, TrackWise, or SFDC.
  • Experience as a quality assurance staff member at a manufacturer's headquarters, including company-wide coordination, guidance to business units, and SOP preparation.
  • Basic knowledge of ISO standards.

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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