QA Specialist/Supervisor at Thermo Fisher Scientific

Tokyo, Japan

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Pharmaceuticals, BiotechnologyIndustries

Requirements

Science degree (e.g., pharmacy, chemistry, biology, engineering, etc.)
Ability to understand the company's product information and usage
Ability to read, write, and negotiate official documents in Japanese
Ability to communicate via email in English and read English manuals
3+ years of experience in development, manufacturing technology/management, or quality assurance at a manufacturer

Responsibilities

Collaborate with quality assurance staff on quality assurance tasks for laboratory equipment, consumables, and lab plastic products
Handle customer inquiries from inside and outside the company: provide responses, record in internal information system (SFDC), report to overseas manufacturing sites, and follow up on reported cases
Accumulate and manage accuracy of information in the internal customer response database
Create and revise business-related documents
Support product launches
Manage notifications to customers for product changes and manage specifications
In case of defects, collaborate with internal departments and overseas manufacturing site staff for root cause investigation, corrective/preventive actions, and customer reporting
Manage, guide, and develop quality assurance staff responsible for the above operations
Strategically and proactively plan and execute problem-solving for business processes and regulatory compliance

Skills

Key technologies and capabilities for this role

SFDCSAPTrackWiseQuality AssuranceCAPARoot Cause AnalysisTeam ManagementCustomer CorrespondenceDocument RevisionEnglish CommunicationJapanese ProficiencyRegulatory ComplianceProduct Specifications

Questions & Answers

Common questions about this position

Is remote work allowed for this QA Specialist/Supervisor position?

The role is based at the Mita headquarters and Yokohama office, with a remote work system available while requiring office attendance 2-3 times per week for communication with internal stakeholders.

What are the required qualifications and experience for this role?

Candidates need a science degree (e.g., pharmacy, chemistry, biology, engineering), understanding of the company's product uses, Japanese proficiency for official documents and negotiations, English ability for emails and manuals, and 3+ years in development, manufacturing technology/management, or quality assurance at a manufacturer.

What is the team structure like for this position?

The position is in the Regulatory Quality Assurance Department (18 members), consisting of the Regulatory Affairs team (4 members) and the Quality Assurance team (14 members).

What training and onboarding is provided?

Onboarding starts with training in the business unit and Regulatory Quality Assurance Department, followed by OJT to master routine tasks, and then gaining experience through internal and external inquiries.

What salary or compensation is offered for this role?

This information is not specified in the job description.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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