QC Bioassay Analyst

RT Lane Recruitment

R.T. Lane Recruitment are currently recruiting for a QC Bioassay Analyst to work with a Pharmaceutical Company in Carlow.

This is an 11-month contract with strong potential for extension.

**Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland**

** Please note due to a high volume of applicants you will only be contacted if suitable for the position. **

POSITION 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.
  • Ensure that all Quality Systems within the department are adhered to daily.
  • Operate as part of the QC team performing the allocated testing and laboratory-based duties.
  • 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.
  •  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,

 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
  • 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.

For more information or a full Job Description please contact – Michelle Power, R.T. Lane Recruitment on 022 46969, 087 032 8195 or email michelle@rtlanerecruitment.ie

To apply for this job email your details to michelle@rtlanerecruitment.ie.