19596-QC Bioassay Analyst-Carlow Contractor

This role is site based on an 11 month contract with a view to extension.

Purpose

Our Client in Carlow has an immediate opportunity for a QC Bioassay Analyst to join our Quality Operation Laboratory. You will operate as part of the QC team performing the allocated testing and laboratory-based duties and although it is preferable that Analysts have Immunoassay and cell culture experience.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality, and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Responsibilities

• Perform and review a range of techniques such as immunoassays, cell-based potency bioassays, and aseptic techniques as part of routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.

• Work as directed by the Bioassay Manager / Associate Director, according to Company safety policies, cGMP, and cGLP.

• Required to drive compliance with our Global policies, procedures, guidelines, and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.

• Required to comply with our 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.

• Ensure that all Quality Systems within the department are adhered to on a daily basis.

• Operate as part of the QC team performing the allocated testing and laboratory-based duties.

• Ensure timely completion of all assigned data processing and reviewing.

• Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures.

• Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, and reports in support of method validation/verifications and equipment qualifications.

• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations, etc.

• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.

• Review, approve, and trend test results where applicable.

• Participate in the laboratory aspects of OOS investigations.

• Provide support with audit/inspection requirements to ensure department compliance/readiness.

• Drive continuous improvement, and 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 whys, etc.

• May be required to perform other duties as assigned.

Requirements

• Bachelor’s Degree or higher preferred; ideally in a science-related discipline.

• Knowledge of regulatory/ code requirements to Irish, European, and International Codes, Standards, and Practices.

• Knowledge of cGMP.

• Laboratory Quality Systems experience.

• Proficiency in Microsoft Office and job-related computer applications required.

• Report, standards, and policy writing skills required.

• Understanding of Lean Six Sigma Methodology preferred.

• Immunoassay and cell culture experience preferable

• Great communicator, a decisive decision-maker with a proven ability to deliver excellence.

• Ability to participate in highly effective teams.

• Desire to continuously learn, improve and develop.

• Willingness to support the team and a strong focus on delivering excellence.

• High personal integrity, credibility, energy and flexibility.

Shift Details

The role is on-site. Will be working 2 cycle shift – Morning (7am -3pm Mon-Thu , 7am-2pm Friday ), Evening (3PM-11PM Mon-Thu, 2pm-9pm Fri) with 20% shift allowance.