PE Global is currently recruiting for a QC Bioassay Analyst on behalf of our client based in Carlow: 11 month initial contract As a 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.
POSITION 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 daily activities.Develop, implement, and maintain procedures that comply with appropriate regulatory requirements.Ensure adherence to all Quality Systems within the department on a daily basis.Operate as part of the QC team performing 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, and validation protocols 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, ensuring data integrity compliance and achieving QC Right First Time KPIs.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, performing root cause analysis on system failures and substandard equipment performance, using standard tools and methods to resolve machine and system issues.Work collaboratively to drive a safe and compliant culture in Carlow.May be required to perform other duties as assigned.QUALIFICATIONS & EXPERIENCE – KNOWLEDGE AND SKILLS REQUIREMENTS Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.Knowledge of cGMP.Laboratory Quality Systems.Proficiency in Microsoft Office and job-related computer applications.Report, standards, and policy writing skills.Understanding of Lean Six Sigma Methodology preferred.Immunoassay and cell culture experience preferable.A great communicator and decisive decision-maker with a proven ability to deliver excellence.Ability to participate in highly effective teams.The desire to continuously learn, improve, and develop.Strong leadership and interpersonal skills.Willingness to support the team with a strong focus on delivering excellence.High personal integrity, credibility, energy, and flexibility.Model the leadership behaviours and use the MPS principles to achieve success.Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.Education Bachelor's Degree or higher preferred; ideally in a science-related discipline.Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 0214297900, or alternatively send an up-to-date CV to ******.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.
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