QC Bioassay Analyst (shift)
RK20672
11 Months
Carlow



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties:

• 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,

• Bachelor’s Degree or higher preferred; ideally in a science related discipline.
• Laboratory Quality Systems experience
• Understanding of Lean Six Sigma Methodology preferred.
• Immunoassay and cell culture experience preferable