Quality , Science, Pharmaceutical & Food

Bioassay Analyst – Carlow

  • Contract
  • Remote
  • Carlow
  • 41934680

PE Global are recruiting for a QC Bioassay Analyst -Shift on behalf of our Bio client site in Carlow:

11 month contract

Shift pattern – 2 cycle shift 5 days over 7. Hours of work – 7am to 3pm / 2:45pm to 10:45pm Monday to Saturday and Sunday 7am to 3pm / 1pm to 8pm 20% Shift premium.

 Role Description

Our client offers a fantastic QC Analytical opportunity for candidates interested in a new challenge in a cGMP regulatory environment.

We have built a new state of the art Quality Operations laboratory, we are looking for Bioassay Analysts who will report directly to  the Bioassay  Manager.

 The ideal candidate will have 1 year experience in a pharmaceutical laboratory, ideally with experience in cell culture and ELISA. Core to the role is to perform release testing of samples.

 Role Functions

(Functions include, but are not limited to, the following)

Responsibilities:

  • Work as directed by the Quality Control Bioassay Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with 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.
  • Ability to lead/mentor team of lab analysts
  • Act as testing SME with QC department, leading OOS investigations and supporting troubleshooting activities
  • Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
  • Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same.
  • Operate as part of the QC team performing the allocated testing and laboratory based duties.
  • The candidate will have responsibilities batch release methods.
  • Perform various analytical techniques cell culture, ELISA’s.
  • Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
  • Provide support with 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, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc,
  • Work collaboratively to drive a safe and compliant culture in Carlow.

Experience, Knowledge & Skills

Minimum Experience:

  • 1 year of experience in a pharmaceutical laboratory.
  • A good working knowledge of ELISA method.
  • A good knowledge of cGMP, GLP, Quality Management Systems.
  • Preference is demonstrated experience with Lean methodologies in a QC environment.

Minimum Education:

  • Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline

 

Please click the link below to apply, call Audrey on 021- 4297900 or alternatively send an up to date CV  Audrey.mccarthy@peglobal.net

 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

  

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