Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives.

Main Duties and Responsibilities:

We are looking for a Pathology Analyst to join our Laboratories Services department in Merthyr Tydfil, Wales.

You will p erform day to day tasks which includ e maintenance, calibration, QCs, and sample analysis , while adhering to the T urn A round T ime (TAT) requirements of the business and sponsors. You will d eliver high quality results to meet clients' needs , Regulatory requirements (GCP and GLP) and ISO 17025: (20 17 ) standard s all whilst e ffectively communicat ing and liais ing with team members and other stakeholders .

You will also assist in the development of methods of analysis, to deliver fully validated assays and documentation of all procedures, making sure that processes are performed as efficient and economical as possible.

Key accountabilities:

• E nsure that work performed adheres to good practice regulations and guidelines.
  
• D ocument procedures undertaken in a clear, accurate and contemporaneous manor and to apply Quality Control (QC) procedures to ensure their accuracy.
  
• C ommunicate the status of work being performed and escalate where appropriate to the pathology laboratory manager , if TAT will not be achieved.
  
• Perform and document routine scheduled maintenance, data back-up and troubleshooting of instrumentation and equipment .
  
• Perform routine calibration and Quality Control (QC) of instrumentation .
  
• A nalyse samples and provide results that can be authorised by Biomedical Scientists or analysts certified as competent to release results .
  
• P repare quality documentation ( s tandard operational procedures, non-compliances, file notes etc. ) within expected timeframes.
  
• E fficiently use consumables and instrumentation to ensure laboratory production costs are minimalised.
  
• Analyse , review and trend monitor internal quality controls and external quality assessment schemes performances .
  
• M aintain personal training records, to demonstrate competency.
  

Minimum Requirements:

Essential:

• Science degree or equivalent.
• Experience in performing analysis in a busy routine laboratory environment
• Good organisation skills, experience in multitasking and able to prioritise work
• Excellent communication skills and fluent in English

Desirable:

• HCPC registered
• Biomedical science degree that is IBMS Registerable
• Previous experience in working in a regulated environment (IS0 17025 15189 or MHRA GCP)
• Research work, hospital laboratory placements and/or relevant experience gained using similar scientific and analytical techniques

Simbec Orion Job Profile - Pathology Analyst .pdf

Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.