Engineer I QA at Thermo Fisher Scientific

Paisley, Scotland, United Kingdom

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Life SciencesIndustries

Requirements

Bachelors/Master’s degree in Chemistry, Microbiology, Engineering or related subject area preferable
Minimum of five years' QA/QC experience in a relevant environment
Working knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR)
Fully competent in all areas of Finished Goods release process
Knowledge of computer applications and current software (Word/Excel) essential
Strong oral and written communication skills
Demonstrated ability to work in a multi-functional team environment and harmonise with all levels in the company
Ability to collaborate with internal and external development team members
Self-starter who can take general concepts and direction and produce desirable results
Ability to function effectively and efficiently in a global, multi-site organization
Appropriate PPE must be worn and used in accordance with instructions

Responsibilities

Review and verify all documentation related to finished good products
Independently resolve inconsistencies or problems with quality or compliance issues
Support daily activities of Core QA department as required
Utilise problem-solving skills related to quality issues ensuring timely resolution for minimal impact
Prepare new documentation and edit/delete revised Standard Operating Procedures, Work instructions, Forms, etc
Continually monitor Finished Good Holds and Fails and independently decide disposition
Utilise Trackwise system for non-conformances, deviations, CAPA
Provide training and support to other QA staff and departments within operations
Participate in customer audits, attend technical visits, and support/engage in customer calls
Embrace site PPI initiatives and ensure all team members embrace this methodology
Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems
Identify and implement opportunities for improvement across the operational function
Participate in personal development to enhance skills and knowledge relevant to the position
Deputy in Team Supervisor’s absence
Perform other related duties as the need arises and/or assigned

Skills

Key technologies and capabilities for this role

ISO13485FDA CFRTrackwiseCAPADeviationsNon-conformancesSOPWork InstructionsQuality AssuranceAuditsProblem Solving

Questions & Answers

Common questions about this position

What education is required for the Engineer I QA position?

A Bachelor's or Master's degree in Chemistry, Microbiology, Engineering, or a related subject area is preferable.

What experience is needed for this QA Engineer role?

A minimum of five years' QA/QC experience in a relevant environment is required.

Is this a remote position, or what is the work location?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What skills make a strong candidate for this QA position?

Strong candidates have problem-solving skills, proficiency in Trackwise for non-conformances and CAPA, knowledge of ISO13485/FDA CFR regulations, and excellent communication skills to work in multi-functional teams.

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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