Overview
Terumo BCT is a global leader in blood management, blood safety, therapeutic apheresis, cell therapy and cell collections. We have an exciting opportunity for a Lab Analyst (Analytical Development) to join Terumo BCT – Larne. The successful candidate will execute testing according to analytical methods and ensure all laboratory equipment is calibrated and maintained, conforming to Terumo BCT Ltd. policies and following procedures in a GMP environment.
Responsibilities
* Perform laboratory analysis based on documented analytical methods and procedures.
* Analyze raw materials, finished goods and other routine and non-routine analyses as required, in accordance with the appropriate test specification.
* Participate in process validation work linked to routine manufacture of pharmaceuticals.
* Carry out routine internal calibration activities of laboratory equipment and ensure maintenance of equipment in good working order.
* Contribute to ongoing continuous improvement initiatives.
* Perform additional investigations for out-of-specification (OOS) samples and related non-conformances.
* Assist in meeting ongoing metric-driven goals and KPIs.
* Maintain neat and accurate analysis records.
* Organise and prioritise workload to meet deadlines.
* Support health and safety (H&S) and COSHH tasks as required.
* Participate in periodic reference standard and chemical stock checks.
* Undertake analytical training courses to develop key skills deemed critical to business needs.
* Assist in the training of other associates as required.
Qualifications and Experience
* Higher level qualification (e.g., HND or degree) in a discipline relevant to testing in QC Chemistry laboratory (e.g., chemistry, pharmaceutical analysis).
* Previous experience of working in a laboratory.
Desirable Skills
* Experience of executing analytical testing in a GMP or ISO 17025 environment.
* Professional experience in cGMP.
* Experience with use/maintenance/calibration of HPLC, UV.
* Experience working to ICH Quality guidelines for Stability and Validation (ICH Q1 and ICH Q2).
#J-18808-Ljbffr