- Subject Matter Expert (SME) for product families including Lateral Flow and Clinical Chemistry.
- Provide technical support for the manufacturing and QC group.
- Facilitate the resolution of technical issues by leading, designing and executing root cause investigations in a timely manner.
- Be an active learner and self-motivator, and consistently seek to attain a higher level of knowledge and experience in In-vitro Diagnostics.
- Be proactive in problem identification and process improvement by trending of manufacturing data and monitoring ongoing robustness of products.
- Ensure the timely generation and completion of necessary technical reports and justifications, and facilitate the efficient completion and closure of documents including NCMRs, Change Controls, and CAPAs etc.
- Have the ability and commitment to work to deadlines alone and as part of a team.
- Show a full commitment to Trinity Biotech quality policy and adhere to the quality system at Trinity Biotech.
- Support the introduction and transfer of new products from R&D or third parties to the Trinity Biotech Bray facility.
- Review, revise, and create documentation as requested.
- Carry out team specific duties within the Technical Services group.
- Provide assistance as required to other Trinity Biotech Product areas.
- A minimum degree in biological/biomedical sciences, Microbiology Biotechnology, Biochemistry or Chemistry is essential.
- A minimum of 3 years' experience within the IVD industry, with proven extensive laboratory experience in In Vitro diagnostics is essential.
- Experience in protein conjugation is preferred.
- Experience in protein coating on nitrocellulose membrane is preferred.
- Experience in clinical chemistry is preferred
- Experience in handling blood based samples and infection disease agents.
- Demonstrated experience in problem-solving and creativity in resolving product or process problems for IVD products.
- Demonstrated competence in a wide range of statistical concepts including Design of Experiments.
- Experience in HPRA/WHO and/or FDA Regulatory requirements.
- The successful applicant will have excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills, and be team focused.
- Meticulous report writing and laboratory notebook keeping.
- Ability to lead and provide support and advice on Products manufactured at Trinity Biotech Bray.
- Ability to make decisions based on technical understanding to ensure that products are technically sound and meet quality requirements.
- Actively learn and have a willingness to learn further about Products manufactured at Trinity Biotech Bray.
- Willingness and ability to collaborate with and influence other individuals and groups in a positive, team-based environment.
- Ability to work independently where necessary.
- Professional characteristics will include initiative, ingenuity, creativity, resourcefulness, and perseverance.
- Excellent problem solving and troubleshooting skills.
- Ability to design, execute, analyze, and interpret experimental work.
- Pay attention to detail and work with a sense of urgency and have the ability to be impartial and objective.
- Be an active learner and developer of self and others with excellent organisational skills.
- Flexibility, adaptability and a professional approach to work, colleagues, and third parties will be expected at all times.
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Technical Services Scientist - Ireland - PARETO SECURITIES AS
Description
Overview of the position of Technical Services Scientist
The Technical Services group is responsible for the provision of technical support to the Production and QC groups, product re-design, process improvement, product integration, new product introduction and product transfer. The Technical Services Scientist will report to the Technical Services Manager.
Technical Services Scientist is responsible for:
Education and Experience:
Skills and Behaviours:
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