18877 – QC Chemistry Analyst – Carlow Contractor

This role is a 12 month contract with a strong view for extension. At this time, the team is working a shift pattern and may divert back to day hours in the coming month, so flexibility at this time is an ask!

2 Shift Cycle – 20% Shift Premium. 

Morning (7am -3pm Mon-Thu, 7am-2pm Friday)
Evening (3PM-11PM Mom-Thu, 2pm-9pm Fri)

Purpose

QC Analytical opportunities for candidates interested in a new challenge in a cGMP regulatory environment. We have built a new state of the art Quality Operations laboratory and we are looking for QC Analysts who will report directly to the QC Chemistry Manager and who will help us in the start-up of this laboratory.

Core to the role is to perform testing of samples to support the release of our key drug products and as Senior QC Analyst you will mentor and lead a team of analysts and complete analytical method transfers, method validation and testing.

Responsibilities

• Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Ability to lead/mentor team of lab analysts
• Act as testing SME within the QC department, leading OOS investigations and supporting troubleshooting activities
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc
• 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 and laboratory-based duties
• Will have responsibilities in analytical transfer and validation of methods.
• Perform various analytical techniques including but not limited to HPLC and UPLC, (HIC, IEX, SEC), Capillary Electrophoresis and other compendial test methods in compliance with cGMP requirements
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
• Provide support with audit/inspection requirements to ensure department compliance/readiness
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc
• Work collaboratively to drive a safe and compliant culture

Requirements

• Bachelors degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline
• 1-3 years of experience in a pharmaceutical laboratory
• Good working knowledge of HPLC and UPLC systems and software is desirable
• Good knowledge of cGMP, GLP, Quality Management Systems
• Preference for demonstrated experience with Lean methodologies in a QC environment
• Method validation and method transfer experience would be advantage