Laboratory/Production Scientist, Medical Devices/ Life Sciences
Location: Deeside Industrial Estate
Salary: Competitive DOE
Hours: Days Monday - Friday
Our Client, a rapidly expanding Medical Devices company is expanding and looking to recruit for an Laboratory Scientist to work at their new state of the art site. The successful candidate will be given further development and progressing - working to ISO 13485 standards.
- As part of the team, manufacture IVD kits, to high quality GMP standards and carry out commercial human identification testing.
- Responsible for the control of raw materials, liquid dispensing, operation of the freeze driers, completion of finished kits, processing DNA samples, and writing laboratory reports.
- You will add value through the continuous improvement of the Clients'
- ISO13485 and ISO17025 quality systems and FDA compliant processes.
- Manufacturing of Client and custom client IVD product lines.
- Operation of liquid dispensers, freeze driers and general laboratory and
- packaging equipment too.
- Completion and maintenance of manufacturing records to ensure compliance
- with Regulatory bodies etc.
- Responsibility for ensuring traceability of all products from raw materials to
- finished product/s.
- Acceptance of raw materials and ensuring that they meet Goods Inward Specifications.
- Assist in the transfer to production of Clients' IVD product lines and the
- generation and design of new production documentation.
- Perform downstream molecular genetic services (capillary electrophoresis)
- and extraction services.
- Receive and handle client samples into the laboratory.
- Setting up PCR and ABI capillary sequencer using appropriate controls and
- PCR amplified products.
- Analysis of microsatellite DNA data.
- Prepare worksheets for DNA extraction, DNA amplification and transfer
- analysed data for preparation of laboratory reports.
- Will hold a Degree in a Biology/Microbiology based discipline.
- Will have some industrial lab experience (placements will be considered); ideally working in an GMP/ ISO 13485 setting (although other industries will be considered).
- The ideal Candidate will have experience using techniques like: PCR, Sterility Tests, Aseptic Techniques, Plate Streaking, Culture Media etc.
- Strong interpersonal skills, and a key eye for quality related issues/ QC based checking.
- Excellent report writing skills and fluent in English.