QC Analyst/Snr QC Technician (Bioassay). Carlow. €20~€22 per hour.

QC Analyst/Snr QC Technician (Bioassay). Carlow. €20~€22 per hour.

Initial 11-month contract. Onsite 2 cycle shift role. 20% shift allowance.

Shift pattern: Morning (7am -3pm Mon-Thurs, 7am-2pm Friday)

Evening (3PM-11PM Mon-Thurs, 2pm-9pm Fri).

Role Description

Our Carlow Site has an immediate opportunity for a number of QC Bioassay analyst/ Snr QC Technician 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, we are open to considering applicants that fulfil the duties as detailed below.

Reporting to the Bioassay Manager / Associate Director.

Role Functions

• 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 and 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, 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, 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,

Experience, Knowledge & Skills

• 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, policy writing skills required
• Understanding of Lean Six Sigma Methodology preferred.
• Immunoassay and cell culture experience preferable
• Great communicator, 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.

Qualifications & Education

• Bachelor’s Degree or higher/equivalent in a science related discipline.