Orion Group Life Sciences are currently recruiting a QC Analyst on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend.
4 cycle shift roles (30% shift premium/12hr shift)
POSITION RESPONSIBILITIES
Work as directed by the QC 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.
REPORTING STRUCTURE
Reports to QC Manager
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
Technical
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 required
Report, standards, policy writing skills required
Understanding of Lean Six Sigma Methodology preferred.
Immunoassay and cell culture experience preferable
Education
Bachelor's Degree or higher preferred; ideally in a science related discipline.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group.
We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion.
In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
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