QC laboratory Specialist
PSC Biotech
- Carlow
- Permanent
- Full-time
- This is a contract based role for a QC Laboratory Technician, as part of the Incoming Quality team at Carlow. The successful candidate will be responsible for supporting the Incoming quality team in the areas of sample management, primary pack inspection, cleaning analysis.
- Building key relationships with both internal and external stakeholders.
- Complete all duties in compliance with GMP and GxP standards.
- Client is expanding site and this is an excellent opportunity.
- Movement of materials across the companys network
- System transactions including movement and shipping of samples across QC labs within the network.
- Knowledge and experience using systems such as GLIMS, LIMS and SAP beneficial.
- Inspection of primary packaging
- Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same.
- Where applicable, review, approve and trend test results.
- Peer review other analysts documentation, ensuring QC Right First Time KPIs are achieved.
- Participate in QC daily meetings and ensure effective communication of testing progress, deviations etc.
- Ensure that all Quality Systems within the department are adhered to on a daily basis.
- Complete all documentation in compliance with GMP and GxP standards.
- Problem solving to get to root cause of issues.
- Provide support with audit/inspection requirements to ensure department compliance/readiness.
- Collaborating with others by sharing your skill-set and expertise
- Drive continuous improvement, perform root cause analysis on system failures e.g. FMEA, Fishbone diagrams, 5 whys etc,
- Drive compliance with Companys Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, including maintenance of accurate records.
- 1 - 3 years’ experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function
- Previous Analytical Experience
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
- Good communication, interpersonal skills and ability to work across teams.
- Degree in Science, Engineering or similar