Quality Control Microbiologist
Position Summary
The QC Analyst I will support commercial and clinical manufacturing activities. This role will ensure compliance in cGMP functions within the QC Microbiology group. This role will assist in completion of all testing related to raw materials and egg white and additionally support internal activities of QC Microbiology.
Principal Responsibilities
• Follows written procedures for bioburden, endotoxin, microbial identification, and growth promotion.
• Supports other activities such as Environmental Monitoring, Utility Monitoring, Product, Qualifications, and investigations as needed.
• Recognizes aberrant test and sample conditions and reports them to the area supervisor/manager with an assessment of the circumstances and potential corrective action if appropriate.
• Writes and compiles investigation documentation.
• Maintains knowledge of current scientific principles and theories.
• Trains other lab personnel as assigned in areas of competence.
• Orders, stocks, receives, labels, logs, and inventories laboratory supplies.
• Provides laboratory support services, cleans/maintains equipment, and prepares reagents/solutions.
• Performs all job functions in compliance with cGMPs and maintains accurate and legible laboratory records.
• Ensures training is current for all job functions performed and attends all required company training.
• May be qualified and assigned to review some laboratory data or documentation.
Qualifications
• 0–2 years of experience in a QC Microbiology role.
• Experience in microbiology techniques including: aseptic technique, bioburden, endotoxin, media preparation, microbial identification, growth promotion testing, environmental monitoring testing, and cell culture.
Education
• Bachelor of Science or higher in Biology / Microbiology
Competencies
• Working understanding of the QC Microbiology laboratory environment, aseptic technique, cleanroom behavior, and familiarity with basic and complex laboratory equipment/instrumentation.
• Ability to understand and follow written SOPs; record all work legibly and in real time with close attention to detail.
• Good knowledge of GMPs and their application in the environment.
• Ability to organize own work on a routine basis with minimal supervision; able to provide updates and tracking on tasks when requested.
• Strong verbal and written communication skills.
• Ability to troubleshoot assays and instruments in area of expertise and offer solutions.
Pharmaceutical Manufacturing and Biotechnology Research
Research
Contract