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Good Laboratory Practice Quality Assurance Auditor

Employer
Labcorp
Location
Huntingdon, United Kingdom
Salary
Competitive
Start date
28 Jul 2021
Closing date
18 Aug 2021

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


Are you an auditor looking for a new role in GLP Quality Assurance (QA)?

Do you want to work in the drug development
industry?

Do you want to be part of a company that helps improve health and improve lives?

As one of the world's premier Contract Research Organisations, we provide research services for a multitude of organisations.We strive to make a difference to people's everyday lives by bringing essential products to the market.

As a Good Laboratory Practice (GLP)Quality Assurance Auditor at Labcorp Drug Development, based at Huntingdon, Cambridgeshire you will play an essential part in making this happen.

Responsibilities will include:

  • Performing protocol, data, report, and in-lab phase inspections for a specific study type to verify conformance to applicable Standard Operating Procedures (SOP's) and Good Laboratory Practice (GLP) regulatory requirements.
  • Evaluating responses to Good Laboratory Practice (GLP) inspection reports and performing follow-up with respondents, management, or others, if needed, to ensure resolution.
  • Ensuring that systems used in Good Laboratory Practice (GLP) quality assurance are properly maintained.
  • Notifying management of service failures.
  • Performing study sign-off including but not limited to quality assurance statement preparation (internal/external) and report finalisation.
  • Performing Standard Operating Procedures (SOP's) reviews.
  • Participating in internal facility and supplemental inspections, under supervision.
  • Deliver basic quality/regulatory training, under supervision.
    Identifying opportunities for process improvement and harmonisation efforts that promote best practices.


What Labcorp Drug Development can offer you:

  • Competitive salaries and a comprehensive benefits package including health cover and contributory pension.
  • Unrivalled opportunities to develop a successful career in the scientific industry.
  • Unsurpassed career development opportunities.
Education/Qualifications:
  • A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience).
  • Experience may be substituted for education.
Experience:
  • At least 12 months in a regulatory environment.
  • Ability to apply basic Good Laboratory Practice regulatory knowledge.
  • Ability to follow instruction e.g. QA documents (Standard Operating Procedures - SOP's).
  • Ability to assimilate/interpret operational documents such that audit can be performed to required level.
  • Ability to critically assess data and apply procedures and regulations.
  • Adaptability to an ever changing work environment.
  • Ability to recognise gaps in procedures and regulations and consult with more senior QA individuals.

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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