Job Description
The position of QC Bioassay Analyst is available at our client's facility in Carlow. This is an 11-month initial contract role.
Key Responsibilities:
* Perform and review various techniques such as immunoassays, cell-based potency bioassays, and aseptic techniques for routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements.
* Report to the Bioassay Manager/Associate Director and ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety, and reliable supply to our customers.
* Work as directed by the Bioassay Manager/Associate Director, according to Company safety policies, cGMP, and cGLP.
* 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.
* 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.
Qualifications and Experience:
* 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.
* 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.
Skills:
* Aseptic technique
* Bioassay
* Cell culture
About Us:
We are committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 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.
We create an interdependent global manufacturing network through partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers. Our goal is to drive continuous improvement, perform root cause analysis on system failures, and resolve machine and system issues.