Responsibilities

• Enters a Laboratory Cleanroom to collect and log samples for microbial analysis.
• Performs bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs).
• Performs or supports the sample analysis for microbial identification.
• Performs environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
• Performs acceptance testing of commercially prepared microbiological culture media.
• Autoclaves microbiological media and laboratory waste as needed.
• Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
• Completes own test records on time and peer reviews data from other analysts for accuracy and completeness.
• Assists in the design and set-up of the QC microbiology laboratory and selection/ implementation and calibration of laboratory instruments.
• Participates in microbiological validations as needed for drug substance, in-process controls, buffers and clean utilities qualification program.
• Assists manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
• Participates in the transfer of methodology from other test facilities.
• Maintains laboratory reagents, media and supplies.
• Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
• Initiates and completes CAPAs and Change Controls in accordance with site procedures.
• Writes new and updates current SOPs as needed.
• Provides training to other analysts in the QC group.
• Presents analytical data reports clearly and concisely to management.
• Proactively identifies and implements lab process improvements, lean initiatives.
• Performs other duties relevant to the QC laboratory position as required.

Requirements

• BS/BA in a scientific/technical discipline.
• 1 - 2 years hands-on work experience in a regulated QC Microbiology laboratory within the biopharmaceutical industry.
• Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc., is an advantage.
• Excellent communication skills, both verbal & written.
• Adaptable and flexible, willing to travel when needed.
• Collaboration and team work. Maintains the highest standards of ethical behaviour.
• Results and performance driven.
• Strong analytical ability and associated problem solving.
• Good time management and attention to detail.
• Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.

Preferred Laboratory Experience

• Microbiology
  • Bioburden
  • Microbial Identification
  • Water Testing – Endotoxin
  • Environmental monitoring
  • Cleaning and validation studies
  • Familiar with USP, JP and EP methodology