• Cork

R.T. Lane Recruitment

Initial 12 month contract role

This position is responsible for carrying out tasks and projects related to raw material, utility, in process, release and stability testing of biotechnology products as required by Good Manufacturing Practice (GMP) and process micro team support.

GENERAL SCOPE OF RESPONSIBILITIES

  • Achieves a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of biotechnology products.
  • Performs routine and non-routine Microbiological and or Biochemical/Chemical testing activities as required.
  • Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
  • Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
  • Trains other QC analysts and Manufacturing personnel in laboratory methods and procedures when required.
  • Writes/updates and reviews TMs, SOPs and WIs as required.
  • Generating, analyzing, reviewing, and reporting QC Micro site trends (Utilities and In Process).
  • Writes and reviews invalid assays, non-conformances and deviations as required.
  • Initiates and drives change controls to completion to implement process improvements.
  • Actively participates in JBIL lean initiatives such as Kaizen, 5S and Gemba.
  • Is an active member of the QC group and provide assistance with other group activities as required.
  • Support the deployment of rapid micro techniques & emerging technologies that may be applied in QC.
  • Investigation support (sample creation, sampling, testing).

SPECIFIC TESTING EXPERIENCE REQUIRED

  • Bioburden
  • Endotoxin
  • Environmental Monitoring
  • Microbial Identification
  • TOC
  • Conductivity
  • pH
  • Nitrates

KEY COMPETENCIES REQUIRED

  • Excellent interpersonal skills
  • Ability to operate as part of a team is critical.
  • To work as a strategic partner with all other departments within the company.
  • Attention to detail
  • Good problem-solving skills
  • Excellent communication skills both written and verbal
  • Good knowledge of LIMS, Track wise and electronic documentations systems.
  • Good knowledge of Microsoft Office applications such as word, excel, PowerPoint
  • Experience working in a high throughput laboratory environment
  • Excellent technical writing skills
  • Good problem solving skills
  • Results and performance driven
  • Adaptable and flexible

QUALIFICATIONS AND EXPERIENCE

  • BSc level 8 (Honours) in a scientific/technical discipline.
  • A minimum of 2 years’ experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
  • Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory

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