22558-QC Bioassay Analyst-Carlow Contractor NEW

Purpose

As QC Bioassay Analyst you will perform and review a range of techniques such as immunoassays, cell based potency bioassays and asceptic techiniques 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. Reporting to the Bioassay Manager / Associate Director you will ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety and reliable supply to our customers.

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 deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Responsibilities

• 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.
• Develop, implement and maintain procedures that comply with appropriate regulatory requirements.
• 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.
• Where applicable, review, approve and trend test results.
• Participate in the laboratory aspects of OOS investigations.
• 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 in Carlow.
• May be required to perform other duties as assigned.
• Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.

Requirements

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