STERILE OPHTHALMIC CDMO

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Careers at Pillar5 Pharma

Quality Assurance Analyst (Microbiology)

Reporting to the Microbiology Team Leader, the role of the Quality Assurance Analyst (Microbiology) is to prepare and perform microbial analysis on raw materials, finished products, blends, bulk products and stability samples as per the procedure and according to specified timelines.

Responsibilities

  • Performing microbial testing:  Microbial Enumeration, Membrane Filtration, Microbial Identification, Gram Staining, Anti-microbial Effectiveness Testing, Bioburden determination, Water analysis (USP and Potable), Growth Promotion Testing and Media Properties Testing, Total Viable Spore Count and Colorimetric Assays.
  • Recording, analyzing and interpreting viable environmental monitoring results from the aseptic processing area and personnel.
  • Environmental monitoring of the non-aseptic processing areas and equipment.
  • Preparing and evaluation of microbiological media, standards, controls and rinse solutions.
  • Preparing and maintenance of frozen stock cultures.
  • Executing validation protocols.
  • Maintenance of laboratory equipment, housekeeping and inspection preparation.
  • Participating in investigations and corrective actions.
  • Participating in investigations and corrective actions.

Qualifications

  • B. Sc. or Diploma in Microbiology, Biochemistry or a related science with related experience in a pharmaceutical manufacturing environment.  Other combinations of technical training and experience may be considered.
  • Sound knowledge of Microbiology test methods (USP) and aseptic techniques.
  • Knowledge of Biosafety practices and tools in a Containment level 2 laboratory.
  • Ability to calculate and perform serial dilutions.
  • Demonstrated ability to work independently and within a team environment.
  • Demonstrated planning, organizational, and time management skills.
  • Experience in routine maintenance and operation of autoclaves, biological safety cabinets, centrifuges, pH meters, plate readers and automatic pipettors.
  • Demonstrate excellent documentation practices and maintenance of records.
  • Excellent oral and written communication skills.
  • Experience and knowledge of computerized information systems.
  • Understanding of Good Laboratory Practices, Good Manufacturing Practices and the Canadian Biosafety Standards and Guidelines.
  • Ability to work shift, overtime and weekends.

Application process: Please send your resume using the form below.