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Contact Info
Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Senior QC Associate


Reference:AMC8318 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst

AMC8318
Senior QC Associate
Contract – 12 months
Dublin


Senior QC Associate


Would you like to join a leading and biopharmaceutical company in Dublin, to further develop your career? This is an excellent opportunity to work on leading technologies in the biotech industry. As a Senior QC Associate, you willbe responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.




To be successful in this role you must have a minimum of 3-5 years laboratory experience in cGMP laboratory environment including exposure to analytical instrument validation experience.


Responsibilities

  • Experience in a wide variety of analytical techniques including but not limited to cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique. Experience with liquid-handling robots is also preferable.
  • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
  • Participate in the peer review of analytical data.
  • Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
  • Lead training of staff on technical aspects of job as required.
  • Develop, revise and implement procedures that comply with appropriate regulatory requirements.
  • Qualification of analytical equipment and related testing functions.
  • Participate in Analytical Method Transfers
  • Compliance with Standard Operating Procedures and Registered specifications.
  • Ensure the laboratory is operated in a safe manner
  • Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
  • Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
  • Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
  • Participate in regulatory agency inspections as required.
  • Plan and implement procedures and systems to maximise operating efficiency.
  • Manage and contribute to the achievements of department productivity and quality goals.



What you need:
  • Bachelor’s degree in a science discipline.
  • 3-5 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
  • Must have Cell based potency bioassays min experience, Cell culture, GMP/GDP Elisa

If you meet the minimum requirements, and feel this is the right role for you, please apply today! For further details please contact Angela McCauley on 00 353 (0)876930951 or send CV in confidence to [email protected]