18448-Quality Technician-Carlow Contractor

This is an 11-month is a two-cycle shift 7-3 and 3-11 Mon-Thur. 7-2 and 2-9 Friday. 20% shift allowance.

Purpose:

This is a contract-based role for a QC Laboratory Technician, as part of the Incoming Quality team. The successful candidate will perform testing/inspection duties as per Quality systems and complete all duties in compliance with GMP and GxP standards.

Responsibilities:

• 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.
• Operate as part of the QC team performing the allocated testing/inspection and laboratory-based duties.
• 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.
• Participate in the laboratory aspects of deviation investigations.
• Problem-solving to get to the 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 why’s, etc,
• Drive compliance with Company Global Policies, Procedures and Guidelines, and 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.

Requirements:

• Degree in Science, Engineering, or similar
• 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.