- JN -012024-1954120
- Jan 16, 2024
Morgan McKinley is delighted to be partnering with our client to assist in the recruitment of a QC Biochemist to join their growing team on a fixed term contract basis.
Morgan McKinley is delighted to be partnering with our client, a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, to assist in the recruitment of a QC Biochemist to join their growing team on a fixed term contract basis.
Reporting to the QC Supervisor, the QC Biochemist is responsible for testing and overall Quality Control of Trinity Biotech manufactured products. Products include Lateral Flow and Clinical Chemistry.
The QC Biochemist will work as part of a team carrying out daily duties according to the company's cGMP and Quality Systems, in order to meet the agreed master production schedule. They will work to key metrics in Health & Safety, Quality/Compliance, Customer Service (internal and external) and Cost. They must be able to demonstrate a proactive approach towards identifying and resolving issues which may impact the schedule or quality of product.
- Completion of test procedures on a daily basis as scheduled, ensuring strict adherence to SOPs.
- Carrying out team specific duties within the QC group
- Being the Subject Matter Expert (SME) on the QC testing for their designated portfolio.
- Ensuring that product meets quality specifications.
- Making decisions based on technical understanding to ensure that products are technically sound and meet quality requirements.
- Ensuring that QC results are in trend prior to approval of product. The QC Biochemist will be responsible for monitoring trends in product performance and should be proactive in problem identification and resolution.
- Working on improvement projects related to their portfolio.
- Facilitating the resolution of OOS (Out of Specification) / NC's (Non-Conformance) investigation by either supporting or leading, designing and executing root cause investigations related to QC in a timely manner. The QC Biochemist will be responsible for ensuring that the OOS/NC testing plan is appropriate for the problem statement and product. They will ensure the timely generation and completion of the necessary reports and justifications, and facilitate the efficient completion and closure of documents including NCMRs, Change Controls, CAPAs etc.
- Reviewing, approving, revising, and creating documentation as requested.
- Assisting when required with other Trinity Biotech Product areas as a QC Biochemist.
- Degree in biological/biomedical sciences, Microbiology, Biotechnology, Biochemistry or Chemistry is essential.
- A minimum of 2 years' experience within the Medical Device industry or similar, with proven experience working in a highly regulated GMP environment.
- Experience with aseptic technique an advantage.
- Demonstrated competence in laboratory / scientific report writing.
- Ability to read, analyze and interpret technical data, technical procedures or governmental regulations.
- Ability to show a high level of care and attention to all aspects of the role and show a desire to achieve excellence through own initiative.
- Proven team player capable of working within multiple areas.
- Strong attention to detail.
- Ability to work with a sense of urgency to meet production deadlines.
- Excellent organisation, planning and judgement skills and ability to positively achieve results through others.
- Flexible and willing to carry out overtime as necessary.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.