QC Biochemist

On behalf of our client, a global diagnostic company, we are currently recruiting for a QC Biochemist. This role reports to the QC Manager and is responsible for testing and overall Quality Control of company  manufactured products. Products include Lateral Flow and Clinical Chemistry.

Responsible for:

• Being the Subject Matter Expert (SME) on the QC testing for their designated portfolio.
• Ensuring that product meets quality specifications.
• Ensuring that QC results are in trend prior to approval of product.
• The QC Biochemist will be responsible for managing, reviewing and improving trending techniques.
• They should be proactive in problem identification, through statistical techniques and process improvement by trending of manufacturing data and monitoring ongoing robustness of products.
• 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.
• Being an active learner and self-motivator, and consistently seek to attain a higher level of knowledge and experience in In-vitro Diagnostics.
• Showing a full commitment to the Quality policy and adhere to the quality system and training given
• Reviewing, revising, and creating documentation as requested.
• Carrying out team specific duties within the QC group. Assisting when required with other company Product areas as a QC Biochemist.

Education and Experience:

• Degree in biological/biomedical sciences, Microbiology Biotechnology, Biochemistry or Chemistry is essential.
• A minimum of 2 years’ experience within the IVD industry or similar, with proven Clinical Chemistry and Lateral Flow QC laboratory experience is desirable but not essential.
• Demonstrated competence in statistical / trending techniques. Ideally experience in a HPRA / FDA Regulatory environment.
• Skills and Behaviours:
• 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 present good sound advice on their product portfolio.
• 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 their portfolio.
• Have the ability and commitment to work to deadlines as part of a team.
• Willingness and ability to collaborate with and influence other individuals and groups in a positive, team-based environment.
• Ability to work independently where necessary
• Ability to prioritise their workload in order to achieve agreed goals and QC targets.
• Professional characteristics will include initiative, ingenuity, creativity, resourcefulness and perseverance.
• Excellent problem solving and troubleshooting skills.
• Ability to design, execute, analyse and interpret experimental work.
• Pay attention to detail and work with a sense of urgency and have the ability to be impartial and objective.
• Flexibility and a professional approach to work, colleagues, and third parties will be expected at all times

For full details contact Linda at +353 1 2784701 or email your CV to ldunne@thornshaw.com. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com