Complete Laboratory Solutions (CLS) is the largest privately owned contract laboratory in Ireland and provides sampling, analysis and fully trained micro and analytical analysts on contract to clients in the food, environmental, medical device and pharmaceutical industries.
CLS operates two of their own accredited laboratory sites, located in Galway City for all things medical and pharmaceutical and Ros Muc for all things food and environmental.
Due to ongoing expansion and based in Galway city, we now require a dedicated, talented person to join our successful team.
Senior Quality Specialist – Molecular Division
- Assuming responsibility for quality control in the Molecular laboratories including validation work, management and control of QC data.
- Ensure a safe laboratory environment – in conjunction with all staff.
- Ensuring all internal and external calibrations are performed as required.
- Performing quality audits.
- Identifying and recording any quality problems and initiating Non Conformance protocols.
- Implement and monitor standards of performance through quality indicators and quality improvement of service – in conjunction with Quality Manager.
- Authorisation of amendments to the manuals and document control.
- Performing trend analysis, reporting, and reviewing performance in proficiency testing.
- Maintaining staff training files and all documentation associated with the Molecular laboratory.
- Ensuring that resources assigned are adequate to perform to ISO 15189 standard.
- Leading and overseeing method validation/verification work in the Molecular laboratory.
- Signatory for molecular analysis, checking results, reports and liaise with the Consultant Clinical Microbiologist and clients.
- Liaise with the laboratory supervisor and team leads on all quality issues.
- When necessary, selecting referral laboratories and monitor the quality of their service – in conjunction with Quality Manager.
- Assisting the Quality Manager in preparation for and participation in external accreditation and customer audits.
- Assisting the Quality Manager in maintaining the quality of tests carried out in the Molecular laboratory, the results obtained and all relating procedures, protocols and records.
- Compliance with ISO 17025, ISO 15189 INAB and ISO 9001 requirements and CLS internal quality and technical procedures.
Skills & Competencies:
- A third level qualification in Molecular Biology or related discipline.
- 3-5 yrs. min experience working in ISO15189 laboratory environment
- Knowledge of ISO 15189 in the clinical laboratory environment.
- A professional, pro-active approach with strong leadership and influencing skills as well as an ability to work efficiently under pressure.
- Can demonstrate an ability to critically review analytical data, excellent attention to detail is a must.
- Experience at building strong relationships across an organisation.
- Be capable of working on own initiative as well as within a team.
- Effective communicator, both verbal and written.
- Proven effective time management skills and ability to manage priorities.
All interested candidates should send their applications to Tom McAvinchey at HR@cls.ie
Closing date for application is 19th March 2021