QC Microbiologist

  • Contract
  • Dublin

Website TPM05418

Summary:
Our Client, a biopharmaceutical company located in Dublin, is looking for a QC Microbiologist. The ideal candidate will be responsible for performing and carrying 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, 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 their Quality Management System requirements.
  • Responsible for driving a culture of Continuous Improvement.

Qualifications & Experience:

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

To apply for this job email your details to lara.miranda-pinto@tandempm.ie.