Purpose
As QC Bioassay Analyst, you will 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. 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 delivering 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.
* Drive compliance with our Global policies, procedures, guidelines, and regulatory requirements, executing Good Manufacturing Practices (cGMP) in the performance of day-to-day activities.
* 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, 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 and deviations.
* Peer review testing documentation, 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).
* 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.
Skills:
* Knowledge of cGMP
* Laboratory Quality Systems
* Proficiency in Microsoft Office and job-related computer applications
* Report, standards, policy writing skills
* Understanding of Lean Six Sigma Methodology (preferred)
* Immunoassay and cell culture experience (preferable)
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