Quality Specialist II at Thermo Fisher Scientific

Singapore

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Life SciencesIndustries

Requirements

Bachelor’s Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a Pharma-related Scientific Area
2 - 4 years of relevant Quality experience in pharmaceuticals preferred
Experience with Quality Management Systems, particularly TrackWise, is an advantage
Experience in biologics and aseptic training is an asset
Experience in maintaining the accuracy and consistency of site data is an asset
Experience with cGMP and Regulatory Compliance along with GMP Quality Management Systems
Effective detailed thinking and interpersonal skills
Strong coordination and teamwork abilities
Focus on delivering effective outcomes
Proficiency in problem-solving and Quality Risk Management
Understand and implement emergency procedures and safe systems of work
Ensure adherence to environment, health, and safety rules, signage, and instructions
Promptly report and investigate all accidents, near misses, and rule breaches

Responsibilities

Write and review relevant procedures and SOPs across various functional teams
Configure and maintain QMS systems to support GxP compliance, authoring related SOPs/Work Instructions
Coordinate site change control, assess changes affecting product quality, and ensure effective management
Maintain and develop actions for CAPA systems, ensuring timely completion and efficiency checks
Perform evaluations to confirm alignment with regulatory requirements
Manage document and record control, ensuring adherence to site requirements
Lead GMP training systems, develop training plans, and improve GMP training modules
Develop and complete annual product quality review plans, including trend analysis and necessary CAPAs
Conduct site self-inspection programs to ensure compliance with cGMP and corporate policies
Coordinate and complete inspection readiness activities for client and regulatory audits
Support site management review processes, collect and analyze quality data, and drive continuous improvement
Coordinate site supplier management programs, including Quality Agreements
Track all QMS events to ensure timely closure
Ensure site data accuracy and successful application throughout the site
Perform additional related duties as assigned by the company

Skills

Key technologies and capabilities for this role

GMPcGMPQMSCAPASOPChange ControlDocument ControlGMP TrainingProduct Quality ReviewSelf-InspectionAudit ReadinessData IntegrityTrend Analysis

Questions & Answers

Common questions about this position

What education and experience are required for the Quality Specialist II role?

A Bachelor’s Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a Pharma-related Scientific Area is required, along with 2-4 years of relevant Quality experience in pharmaceuticals preferred.

What is the work schedule and location for this position?

This is a full-time position with a standard Monday-Friday work schedule, conducted in an office environment adhering to GMP safety standards. Remote work policy is not specified.

What salary or compensation does this role offer?

This information is not specified in the job description.

What are the key responsibilities of the Quality Specialist II?

Key responsibilities include writing and reviewing SOPs, configuring QMS systems for GxP compliance, managing CAPA systems, conducting self-inspections, and coordinating supplier management and audits.

What experience makes a candidate stand out for this role?

Candidates with experience in Quality Management Systems like TrackWise, biologics and aseptic training, and maintaining site data accuracy will stand out, in addition to the minimum 2-4 years of pharma quality experience.

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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