Quality Assurance Auditor
Job Title: Quality Assurance Auditor
Job Level: Trainee or Experienced
Department: Quality Assurance
Contract Type: Permanent
Salary: Negotiable (dependant on experience)
Working Hours: 37.5 hours per week
Alderley Analytical is fast growing Contract Research Organisation (CRO) based at the prestigious Alderley Park in the heart of Cheshire. We provide specialist bioanalytical services to support our clients with their discovery and regulatory drug development programmes. We provide services to support our clients with their small & large molecule, peptide, oligonucleotide and biomarker projects.
Our facility has a wealth of state-of-the-art LC-MS/MS instruments complimented by many other analytical technologies.
The Quality Assurance (QA) department supports the bioanalytical facility by monitoring studies, procedures and reports that are compliant with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). They provide 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.
Due to the ongoing success of Alderley Analytical, we are looking for a Quality Assurance Auditor to join the QA Group to support the workload of the QA department.
Alderley Analytical will offer the successful candidate an interesting and fulfilling career and to be part of an exciting growth step of the company. The right candidate will receive an excellent renumeration package including a competitive salary, private healthcare, generous holidays, discount scheme and pension fund.
- You will be part of our busy QA team to assure management that the facility is operating in compliance with the UK regulations by participation in audits, data and report reviews.
- Advise Test Facility Management and give general assistance in relation to the compliance programme
- Audit documents and scientific data to ensure that the regulatory studies are planned, executed, and reported fully and accurately.
- Inspections of the study procedures, laboratory processes and facilities interacting with staff at all levels.
- To maintain an awareness of the requirements of GLP and laboratory GCP current thinking/regulatory guidance worldwide.
- Advise upon and audit computer validation activities and assure validation documentation complies with regulatory requirements.
- Perform 3rd party supplier audits in order to monitor quality practices and standards.
- Communicate effectively and maintain robust knowledge of the requirements of GLP and laboratory GCP current thinking/regulatory guidance worldwide.
- Business aware of developments in industry in the context of QA activities
- Deliver regulatory training for all staff at Alderley Analytical to ensure an awareness of GLP and laboratory GCP
- A degree in Life Sciences or chemistry related subject.
- Experience working in an environment adhering to regulatory standards (GLP, GCP, GMP, ISO)
- An eye for detail and the determination to complete tasks to a high standard within tight deadlines.
- Good decision making, negotiating, organisational and problem-solving skills.
- Ability to work under minimal supervision
- Excellent computer literacy and competent in Microsoft office applications Outlook, Powerpoint, Word, Excel.
Additional Requirements (not essential)
- Minimum year of experience auditing in a relevant or relatable quality standard (GLP, GCP, GMP, ISO)
- Experience of working within a GLP Test Facility.
- Knowledge of specific scientific software platforms
- Experience working in a regulatory bioanalytical laboratory