GLP Quality Assurance Auditor
Laboratory Corporation of America Holdings (Covance)
Harrogate, United Kingdom
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.
- A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience).
- Experience may be substituted for education.
- 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.