Simbec Orion Group Ltd

Senior Laboratory Analyst

Location
Merthyr Tydfil, Wales
Salary
Competitive
Posted
27 May 2021
Closes
26 Jun 2021
Ref
VA117
Discipline
R & D , Laboratory
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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.

Summary of the Position:

We are looking for a Senior Laboratory Analyst to join our Laboratories Services department.

You will perform the day to day tasks which include maintenance, calibration, QCs, and sample analysis and will be accountable for the approval and release of laboratory results for the business and sponsors. You will support on the various quality and compliance standards and will deliver high quality results to meet Regulatory requirements (GCP and GLP) and ISO 17025: (2017) standards all whilst effectively communicating and liaising 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:

  • Approve and release Pathology results in line with expected standards.
  • Act as a LIMS (Lab Information Management Software) superuser.
  • Conduct effective QC checks on study related documentation.
  • Ensure that work performed adheres to good practice regulations and guidelines.
  • Document procedures undertaken in a clear, accurate and contemporaneous manor and apply Quality Control (QC) procedures to ensure accuracy.
  • Analyse samples within the expected Turn Around Time.
  • Communicate the status of work being performed and escalate where appropriate to the Pathology Supervisor.
  • Perform and document routine scheduled maintenance, data back-up and lead troubleshooting of instrumentation and equipment.
  • Perform routine calibration and Quality Control (QC) of instrumentation.
  • Prepare quality documentation (standard operational procedures, non-compliances, file notes etc.) within expected timeframes.
  • Efficiently 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.
  • Maintain personal training records, to demonstrate competency.


Minimum Requirements:

Essential:
  • Experience in performing analysis in a laboratory environment
  • Biomedical Science degree or equivalent HCPC registered
  • BioMedical Scientist in blood science or multi-disciplinary (including haematology and biochemistry).

Desirable:
  • 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.
  • Experience with Roche Cobas 6000, Cobas 6500, T511 and Sysmex XN-2000 or equivalence.
  • Experience with blood film review and interpretation.


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.