Quality Technician (Bioassay Analyst)

  • Contract
  • Carlow

Website TPM05319

Summary:
Our client, a biopharmaceutical located in Carlow, is looking for a Quality Technician (Bioassay Analyst). The successful candidate will be responsible for performing and reviewing 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.

Responsibilities:

  • 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, non-conformances, 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.
  • May be required to perform other duties as assigned.

Qualifications & Experience:

  • Bachelor’s Degree or higher preferred; ideally in a science related discipline.
  • 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.

To apply for this job email your details to lara.miranda-pinto@tandempm.ie.