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Microbiology Quality Control Analyst

3 months ago

Glasgow, Glasgow City, United Kingdom Curia Full time

About Curia

Curia is a leading provider of global contract research and manufacturing services tailored for the pharmaceutical and biotechnology sectors. We are excited to offer an opportunity to join our expanding Microbiology team. This role is ideal for recent graduates eager to launch their careers with comprehensive training in a dynamic global environment. Our commitment to excellence is driven by the significant impact our work has on improving patient outcomes through the pharmaceuticals we develop and produce.

Role Overview

The Microbiology team plays a crucial role in supporting our facility by ensuring that all samples, including Active Pharmaceutical Ingredients (API), excipients, in-process samples, finished products, stability samples, and water testing, are managed efficiently and accurately. Our responsibilities encompass effective environmental monitoring, staff gown monitoring, and providing guidance on maintaining robust microbial control. All activities are conducted within our facility, adhering to Good Manufacturing Practices (GMP) to ensure the production of sterile products.

Key Responsibilities

  1. Conduct enumeration of microbial growth from environmental monitoring plates and various microbial samples.
  2. Perform microbial identification using techniques such as Gram stain, spore stain, and Vitek.
  3. Collect process water samples and conduct Total Viable Count (TVC), Total Organic Carbon (TOC), and pH testing.
  4. Download and assess particle counts.
  5. Execute 'at rest' environmental monitoring.
  6. Train and monitor cleanroom operators' gowning procedures, ensuring personal gown qualification.
  7. Inspect and promote growth of pre-prepared and PST media.
  8. Conduct relevant checks, including airflow and temperature assessments of incubators, fridges, and freezers, as well as equipment calibration checks.
  9. Identify system failures and report them promptly to senior department members and line management, following established SOPs.
  10. Report Out of Specification (OOS) results and atypicals to key personnel.
  11. Maintain high standards of housekeeping and safety, including performing cleaning and disinfectant testing in cleanroom environments.
  12. Conduct bioburden validation.
  13. Ensure completion and proper filing of relevant documentation and reports in compliance with GMP and departmental protocols.
  14. Perform product and water endotoxin testing using kinetic turbidometric methods.
  15. Conduct sterility testing and validation utilizing membrane filtration techniques.

Qualifications and Skills

  1. A degree in a Science-related discipline, preferably in Biology or Microbiology, is highly desirable.
  2. Experience operating laboratory equipment is advantageous.
  3. Demonstrated practical skills in Microbiology are preferred, along with knowledge of GMP environments and regulatory commitments such as GMP, ICH, and COSHH.

Commitment to Learning

At Curia, we prioritize ongoing training and development in Microbiology and related fields. The role requires the ability to manage a high volume of samples, necessitating the Analyst to:

  1. Organize their workload effectively with guidance from their line manager.
  2. Adapt to shifting priorities without compromising quality.
  3. Maintain awareness of workload levels and communicate priorities to line management as needed.
  4. Ensure meticulous documentation with clear structure and legibility.
  5. Embrace a culture of 'right first time'.

This position is well-suited for recent graduates at the beginning of their careers. A comprehensive training program will be provided, with opportunities for rapid progression within our growing team.

Work Schedule

The role involves 8-hour shifts, including breaks, with the possibility of paid overtime.