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.
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.
POSITION RESPONSIBILITIES
* Work as directed by the Bioassay Manager / Associate Director, according to Company safety policies, cGMP and cGLP.
* Drive compliance with Global policies, procedures and guidelines and regulatory requirements; execute Good Manufacturing Practices (cGMP) in day-to-day activities.
* Develop, implement and maintain procedures that comply with appropriate regulatory requirements.
* Ensure adherence to 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.
* Complete Laboratory Investigation Reports and deviations through site procedures in a timely manner.
* Participate in generating trend data, investigations, nonconformances, validation protocols, and reports in support of method validation/verifications and equipment qualifications.
* Participate in QC Tier 1 daily meetings to communicate testing progress and deviations.
* Peer review testing documentation ensuring data integrity compliance and QC Right First Time KPIs are achieved.
* Review, approve and trend test results where applicable.
* Participate in laboratory aspects of OOS investigations.
* Support 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.
* Work collaboratively to drive a safe and compliant culture in Carlow.
* May perform other duties as assigned.
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.
* Report, standards, and policy writing skills.
* Understanding of Lean Six Sigma Methodology preferred.
* Immunoassay and cell culture experience preferable.
People
* 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 leadership behaviours and use 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.
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