We are seeking a highly skilled and detail-oriented QC Bioassay Analyst to join our team on an 11-month initial contract based in Carlow.
Job Description:
The successful candidate will perform and review various techniques such as immunoassays, cell-based potency bioassays, and aseptic techniques as part of routine and non-routine testing and project work. This is essential to ensure that processes and end products comply with corporate and regulatory requirements for product release.
The QC Bioassay Analyst will report to the Bioassay Manager/Associate Director and ensure that objectives are effectively achieved, consistent with our requirements for compliance, safety, and reliable supply to our customers.
Key Responsibilities:
* Work as directed by the Bioassay Manager/Associate Director, following Company safety policies, cGMP, and cGLP guidelines.
* Drive compliance with global policies, procedures, and guidelines, and execute Good Manufacturing Practices (cGMP) in daily activities.
* Develop, implement, and maintain procedures that comply with applicable regulatory requirements.
* Evaluate and ensure adherence to Quality Systems within the department.
* Participate in laboratory-based duties as part of the QC team.
* Ensure timely completion of assigned data processing and reviewing.
* Prepare Laboratory Investigation Reports and deviations through site procedures.
* Contribute to trend data generation, investigations, nonconformances, validation protocols, reports for method validation/verifications, and equipment qualifications.
* Engage in QC Tier 1 daily meetings and communicate testing progress, deviations, etc.
* Peer review testing documentation and ensure data integrity compliance and achievement of QC Right First Time KPIs.
* Review, approve, and trend test results where applicable.
* Participate in laboratory aspects of OOS investigations.
* Support audit/inspection requirements for department compliance/readiness.
* Participate in internal and external audits and inspections, taking on auditee roles for assigned areas of responsibility.
* Drive continuous improvement and perform root cause analysis on system failures and substandard equipment performance using standard tools and methods.
* Collaborate to drive a safe and compliant culture in Carlow.
Qualifications and Experience:
The ideal candidate will possess knowledge of regulatory/codes requirements for Irish, European, and International Codes, Standards, and Practices, as well as cGMP knowledge. They should also have proficiency in Microsoft Office and job-related computer applications, along with report, standards, policy writing skills. Additionally, experience in immunoassay and cell culture is preferable.
A great communicator, decisive decision-maker with a proven ability to deliver excellence is required. Ability to participate in highly-effective teams, continuous learning, strong leadership and interpersonal skills, willingness to support the team, and a focus on delivering excellence are also essential.
Education:
A Bachelor's Degree or higher in a science-related discipline is preferred.