QC Bioassay Analyst

Orion Group Life Sciences are currently recruiting a QC Bioassay Analyst on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month Contract with potential to extend.

2 cycle shift Morning (7am -3pm Mom-Thu , 7am-2pm Friday ), Evening (3PM-11PM Mom-Thu, 2pm-9pm Fri) (20% shift premium)

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• 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,

In order to excel in this role, you will more than likely have:

• Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
• Knowledge of cGMP
• Laboratory Quality Systems experience
• 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
• Great communicator, decisive decision-maker with a proven ability to deliver excellence
• 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.