Job Description

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 Drug Development, based at Shardlow, Derbyshire you will play an essential part in making this happen.

The Shardlow site is the epicenter of aquatic ecotoxicology and biodegradation. They focus on crop protection and chemical testing.

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 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.