Quality Specialist II at Thermo Fisher Scientific

Bohemia, New York, United States

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Clinical TrialsIndustries

Requirements

Bachelor of Science (required) in Engineering or Life Sciences-related field; Master of Science preferred
4 years of experience with Management Systems
Knowledge of directives (EU-GMP, US FDA 21 CFR) including Part 11 requirements
Strong interpersonal, verbal, and written communication skills
Excellent proficiency in personal computer applications such as Microsoft Outlook, Word, Excel, and PowerPoint
Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems, including root cause analysis

Responsibilities

Develop and lead metrics related to CLS Quality compliance and present to Senior management on a scheduled basis
Support site Data Integrity Initiatives
Assist in taking part in the internal and external audit programs
Complete action items associated with investigation reports related to compliance actions
Establish new procedures and update existing ones as applicable
Support review and implementation of corporate and division policies
Maintain site compliance with GxP related to US and EU clinical labeling
Review all Quality Agreements and collaborate with Client Services to ensure all client-specific requirements are included
Support quality on the Change Control Committee
Support the routing and approval of client Change Notifications
Assist the quality team with any issues related to Global TrackWise or Documentum

Skills

Quality Management System

Regulatory Compliance

Auditing

Supplier Management

Data Integrity

Metrics Development

Investigation Reports

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.

Land your dream remote job 3x faster with AI

Try Jobo Free