Scientific Officer - Quality Assurance

Job Description

Scientific Officer (Quality Assurance)

Two year fixed term contract role; salary based

Start : ASAP

A Scientific Officer (Quality Assurance) is required for our higher education client to join their quality assurance team within their research centre to contribute to their compliance by assuring that their clinical trial activities comply

with good clinical practice (GCP) regulations and guidelines for laboratories.

You will work alongside multidisciplinary laboratory and support teams and contribute to maintaining and assuring that their Quality Management System (QMS) and associated documents are fit for purpose, that non-conformances are addressed, all regulated documentation and associated records are up to date, and provide guidance in relevant regulations, standards, and procedures. You will have the opportunity to work closely with personnel at all levels of the organisation to assure their regulated GCP activities meet the required standards.

As the Scientific Officer you will possess experience in a quality assurance or compliance role within aGxP regulated laboratory with knowledge of GCP regulations, internal audits, non-conformance (or deviation) and CAPA management. Ideally you will have experience with LIMS and QPulse.

You will possess BSc (or equivalent) in Science or a related subject or have equivalent relevant experience. Duties include :

Using a range of Quality Management System procedures (training provided) duties will include conducting document reviews on behalf of QA.

Undertake project reviews and activation within the laboratory information management systems (LIMS)

Conduct scheduled internal audits

Support the completion of non-conformances and the timely delivery of QA activities Ensure all QA documentation is completed and up to date

Prioritising workload whilst keeping the Head of Quality Assurance informed with regards to developments in the progress of projects Interact with specialist teams and groups on all matters of GCP (Good clinical practice) compliance Essential skills & experience required : BSc (or equivalent) in Science or related subject or (equivalent relevant experience) Relevant QA or compliance experience working in a regulated academic research or industrial laboratory setting.

Working to GxP standards

Experience of internal audits, non-conformances and CAPA management (Corrective and preventative actions)

Track record of delivering high quality work within agreed deadlines Knowledge of :
Familiar with basic computing software ( MS office)

• Knowledge of GCP (Good Clinical Practice), GLP (Good Laboratory Practice), or GCLP (Good Clinical Laboratory Practice) requirements.
• Knowledge of audit and non-conformance management
• Knowledge of root cause analysis techniques
• Experience with LIMS
• Experience with Q-Pulse software or equivalent electronic QMS
• Experience in training staff
• Experience of working in a translational / clinical environment
• Experience of working to GCP, GLP or GCLP standards