Quality Assurance Associate at Thermo Fisher Scientific

East Grinstead, England, United Kingdom

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Pharmaceuticals, HealthcareIndustries

Requirements

Degree in microbiology or a related field
Confirmed experience in a QMS role, preferably within MDR/IVDR
High attention to detail
Ability to communicate openly
Flexibility in meeting targets
Proficiency in the use of the MS Office suite
Ability to maintain accurate records with attention to detail
Ability to work independently and in a group setting with little direction or direct supervision
Experience in audit involvement
Priority oriented to ensure deadlines are met
Experience with writing concise/accurate reports

Responsibilities

Ensure general day-to-day activities such as approval of manufacturing documentation including technical reports, review/approval of non-conformances, deviations, reviewer/approver for SOP’s, briefs, software, specifications and forms
Ensure compliance and assist in audits (pre-audit and post-audit follow-up) to external (regulatory) requirements, including Quality Management Systems (ISO 13485:2016, MDSAP) and the In Vitro Diagnostics Regulations
Ensure corrective actions are implemented for issues arising from audits
Responsible for reviewing and approving SOPs in line with change process
Co-ordinate investigation of customer complaints and general quality advice to the business
Undertake QA responsibilities regarding supplier control, review and performance
Act as coordinator and/or QA Representative on Corrective Action investigations
Perform internal audits to ensure compliance to external regulatory requirements
Assist in metric data for the Quality department
Assist in training for Quality functions and relevant documentation in up-to-date

Skills

Quality Assurance

GMP

ISO 13485:2016

Document Control

Batch Release

Non-conformances

Deviations

SOP Review

Audits

MDSAP

In Vitro Diagnostics

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