QC Microbiologist

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JOB SUMMARY:

This job tests raw materials, utilities, in-process materials, final product, cleaning samples and biological indicators for microbial attributes according to, compendia cGMP and material/product specifications.  This job will also read plates and record results and perform microbial identification activities.

MAJOR RESPONSIBILITIES:

• Employ good documentation practices when generating raw data, reports, SOPs, and other documentation
• Receive test samples.
• Prepare reagents, standards, controls, and samples for analysis
• Follow established procedures for the receipt, use and management of inventory of reagents, test media and supplies
• Perform microbial tests including LAL, Bioburden, Microbial Identification, BI testing, and Growth Promotion Testing
• Collect, analyse, interpret, and report data
• Verify data including peer review of data where required
• Provide data for the preparation of quarterly trending reports
• Perform scheduled cleaning and other laboratory housekeeping duties as assigned
• Implement both immediate and long-term Corrective Actions
• Participate in Out of Specification investigations
• Review SOPs and Test Methods, and process updates when required
• Report to supervisor/manager any deviation from procedures or other discrepancy that may affect quality or cGMP
• Provide training to other Associate, QC Microbiologists when requested
• Perform Environmental Monitoring as a backup, if required
• Report Health and Safety incidents, accidents, or potential hazards
• Performs all other job-related duties as assigned

MINIMUM QUALIFICATIONS:

TECHNICAL KNOWLEDGE / EXPERIENCE:

• Bachelor’s degree in Life Science or Microbiology college diploma/certification
• Basic understanding of microbiology test methodologies
• Knowledge and understanding of GMP, compendial test requirements
• Basic understanding of data analysis, statistics, and report preparation with knowledge of MS Word and Excel
• Must have the ability to work independently, multi-task, be self-motivated, highly organized, and able to work in a fast- paced quality control environment
• Strong attention to detail in job execution and data completion and review

PREFERRED QUALIFICATIONS:

• Knowledge and understanding of GMP, compendial test requirements, US, and European Pharmacopeia

ADDITIONAL REQUIREMENTS:

• Pre-employment medical and medical re-examination; inclusive of eye examination and colour blindness test, performed every 2 years or as per **MEMBERS ONLY**SIGN UP NOW***.’s SOPs     
• This position requires vaccination for Hepatitis A and B
• Job requires shift work, weekends, and occasional extended shifts and possible short notice schedule shifts

BEHAVIOURAL:

Demonstrated ability to apply the following behavioural competencies on the job:

Problem Solving:  Anticipating, analyzing, diagnosing and resolving problems.

Goal Orientation: Energetically focusing efforts on meeting a goal, mission, or objective.

Written Communication: Writing clearly, succinctly, and understandably.

Decision Making: Utilizing effective process to make decisions.

Organization and Planning: Utilizing logical, systematic, and orderly procedures to meet objectives.

Flexibility: Agility in adapting to change. Ability to work independently

Attention to Detail: Ensure work or reviews are correct and Right First Time.

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