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QC Analyst 12 Month FTC

External
gehc logoGehc · Cork
Full-timeOn-site1w ago
ComplianceDocumentation
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Responsibilities

  • Providing QC support during batch manufacture, ensuring turnaround times are achieved as outlined in QC/Production Service Level Agreement and product release times.
  • This includes In process Chemistry/Microbiological analysis, finished product Chemistry/Microbiological analysis.
  • WFI & Steam sampling and analysis
  • Performing and Managing the Environmental Monitoring programme in conjunction with clean room operators.
  • Support of batch release through isolation and identification of microorganisms and further analysis including Heatshock testing and Growth Promotion testing.
  • Establishing best practice standards within the clean room and focusing on driving appropriate clean room behaviours.
  • Actively involved in Investigations e.g. Batch Corrections, EMI, Bioburden etc
  • Actively involved in report and protocol generation e.g. Quarterly trend reports
  • Performing routine instrument calibrations and calibration checks.
  • Routine validation and maintenance of equipment
  • Ensuring compliance with cGMP, EHS, GxP etc guidelines at all times.
  • Entering and approving results on LIMS/MODA & completion of batch documentation
  • Assist with audits as required.
  • Generation/Reporting of key performance indicators for the group.
  • Be proactive in approach planning for future and implementing improvements in effective manner.
  • To develop areas of expertise in analytical testing in order to solve technical issues.
  • Planning and resourcing for plant specific projects that require QC services.
  • Ensure compliance with current pharmacopoeia and all regulatory/company guidelines.
  • Interaction with other departments e.g. Production, Engineering, QA.
  • Keep colleagues informed of current issues and developments as appropriate
  • Assist in the training and up skilling of colleagues.
  • Liaising with internal and external customers in relation to QC/Production issues
  • Reasonable level of overtime will be required to facilitate business needs

Requirements

  • Science Qualification and equivalent lab experience.
  • Good communications skills, excellent time management skills, flexibility and agility will be required.
  • Openness to change.
  • Proven ability to work on own initiative.
  • Pharmaceutical experience in a GMP regulated laboratory environment.
  • Inclusion and Diversity
  • Behaviors
  • We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

Benefits

#LI-MG1Additional InformationRelocation Assistance Provided: NoHealth insurance

Additional Information

Job Description Summary To provide Quality Control support during batch manufacture and filling process. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world Job Description


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