QC Microbiology Analyst

1 month ago

Ireland Tandem Project Management Ltd. Full time

Summary:
Our client, a biopharmaceutical company located in Dublin, is seeking a QC Microbiology Analyst. The ideal candidate role will ensure efficient and effective compliant, qualification, and operation of the new strategic Drug Substance facility. The successful candidate will also perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI sampling & testing, growth promotion testing, TOC & Conductivity testing, in-process product testing, final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements.

Responsibilities:

  • Perform supportive activities for general lab readiness, laboratory equipment qualification and method qualifications.
  • Integrate and complete all documentation on time and be familiar with LIMS.
  • Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards.
  • Support the laboratory testing schedule to achieve an efficient QC system.
  • Receive and manage samples that come into the lab for testing.
  • Solution preparation, cleaning, routine equipment maintenance and system set-up.
  • Writing and update of SOPs.
  • Maintain good housekeeping and GLP within the laboratory.
  • Calibrate and maintain all designated laboratory instruments.
  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
  • Ensure training is current for all job functions performed.
  • Assist in training new analysts on routine procedures and practices.
  • Order stock and receive laboratory supplies.
  • Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
  • Ensure that cGMP standards are maintained at all times.
  • Delivery of area performance to meet or exceed performance or quality goals.
  • Promote and participate in the implementation and maintenance of the relevant safety programmes.
  • Participate and comply with the Quality Management System requirements.
  • Responsible for driving a culture of Continuous Improvement.

Qualifications & Experience:

  • Bachelor’s Degree qualification (Science/Quality/Technical), Masters preferred.
  • 1 to 3 years industry experience with significant knowledge and experience working in a Microbiology Laboratory.
  • Experienced in testing as per the pharmacopeia’s.
  • Working knowledge of QC Systems (eLogs, Electronic Lab Notebook, LIMS etc.).
  • Preference Lean Six Sigma.
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