GLP Quality Assurance Auditor

Laboratory Corporation of America Holdings (Covance)

Harrogate, United Kingdom


Job Overview:

Are you already working in a GLP / GCP environment and want to consider Quality Assurance as your next career move?

 

Do you want to be part of a company that helps build a healthier and safer world?

 

Are you looking for industry recognised training and development opportunities?

 

Labcorp is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. 

 

As a Good Laboratory Practice (GLP) Quality Assurance Auditor at Labcorp, based at Harrogate, North Yorkshire 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 GLP regulatory requirements.
  • Evaluating responses to GLP inspection reports and performing follow-up with respondents, management, or others, if needed, to ensure resolution.
  • Ensuring that systems used in GLP quality assurance are properly maintained.
  • Notifiying 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 Procedure (SOP) reviews.
  • Participating in internal facility and supplemental inspections, under supervision.
  • Deliver basic GLP quality/regulatory training, under supervision.
  • Identifying opportunities for process improvement and harmonisation efforts that promote best practices.

 

What Labcorp 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:

  • Proven work history in a regulatory environment.
  • Ability to apply basic relevant regulatory knowledge - GLP/GCP.
  • Ability to follow instruction e.g. QA documents (SOPs).
  • 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.


2021-09-07 10:10:42


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