Quality Assurance Officer

Job Title: Quality Assurance Officer
Reports to: Head of Quality Assurance

ROLE OVERVIEW
Alderley Analytical is an independent fast growing Contract Research Organisation (CRO). We offer specialist bioanalytical services to support drug development programmes, from discovery through to late stage clinical development, focusing on small molecules, large molecules, peptides and biomarkers.

The Quality Assurance Unit at Alderley Analytical supports the bioanalytical facility by monitoring studies, procedures and reports that are compliant with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

The role will require you to give advice on compliance and quality issues and look for improvement opportunities to working practices to ensure that compliance with the UK GLP and GCP regulations is maintained at Alderley Analytical.

Job Type:
Full-time

Key Responsibilities:
You will be part of our busy QA team to assure management that the facility is operating in compliance with the UK regulations.

The tasks involved include:

  • Scheduling of work within QA and co-ordinate activities for the Quality Assurance Unit.
  • Study plan reviews to ensure the regulatory studies are planned correctly.
  • Inspections of the study procedures, laboratory processes and facilities interacting with staff at all levels.
  • Audits of scientific reports to assure that the reports fully, accurately and completely describe the data generated on studies.
  • To advise upon and audit computerised system validation activities and assure validation documentation is in compliance with regulatory requirements.
  • Design and deliver GLP and GCP training to the scientific team.
  • To advise the scientific team on matters of quality and compliance.
  • Supporting the Test Facility Manager in the planning and hosting of external client audits and government agencies.
  • To maintain an awareness of the requirements of GLP and laboratory GCP current thinking/regulatory guidance worldwide.
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Minimum Requirements:

  • A degree in Life Sciences or chemistry related subject.
  • An eye for detail and the determination to complete tasks to a high standard within tight deadlines.
  • A good communicator with strong interpersonal skills.
  • Experience of working within a GLP Test Facility.
  • Experience of working in a Quality Role in GLP or GCP.

Additional Requirements:

  • Experience of working as a QA professional ideally within a GLP Test Facility.
  • Understanding of problem-solving tools such as Corrective Action Preventive Action (CAPA), root cause analysis.
  • Either worked in a bioanalytical laboratory or have bioanalytical knowledge
  • Good computer literacy and competent in Microsoft office applications Powerpoint, Word, Excel.

Apply NOW by sending your CV with a covering letter to info@alderleyanalytical.com.

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