Laboratory Quality Assurance Specialist

1 week ago

Cork, Cork, Ireland CPL Full time
Job Description

We are seeking an experienced Laboratory Analyst to join our analytical laboratory project team. The successful candidate will work on various activities including test method validation, equipment validation, training, and development of laboratory processes and Standard Operating Procedures (SOPs).

Key Responsibilities:

  • Adhere to all company Environmental Health and Safety (EHS) guidelines and procedures.
  • Develop and validate laboratory test methods.
  • Collaborate on the preparation and execution of the Project Validation Master Plan.
  • Prepare validation and other related documentation.
  • Execute protocols and compile reports.
  • Train on laboratory procedures and develop onboarding plans for future analysts.
  • Lead analytical method development/troubleshooting for the project laboratory groups.
  • Review laboratory data for accuracy.
  • Validate laboratory equipment, software, spreadsheets, and methods.
  • Perform validation, release, and non-routine testing as required.
  • Support site commercialization readiness.
  • Maintain lab fitness for audits.
  • Ensure compliance of the laboratory projects to all applicable quality, regulatory, and Pharmacopeia requirements.
  • Work within Filtration 2.0 laboratory calibration and preventative maintenance system.
  • Provide technical support to all F2.0 functional groups as required.
  • Ensure laboratory project timelines are adhered to.
  • Ensure protocols, reports, test methods, SOPs, and all other relevant documentation are drafted and approved prior to use.
  • Ensure all laboratory investigations are completed in a timely manner.
  • Contribute to risk mitigation initiatives such as FEMAs and risk assessments.
  • Identify and participate in Continuous Improvement initiatives.

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