Quality Control Analyst I

Responsibilities

• Supports commercial and clinical manufacturing activities.
• Ensures compliance in cGMP functions within the QC Microbiology group.
• 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 inventory 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.
• 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.
• Experienced in microbiology techniques: Aseptic Technique, Bioburden, Endotoxin, Media Preparation, Microbial Identification, Growth Promotion Testing, Environmental Monitoring Testing, and Cell Culture.
• Bachelor of Science or higher in Biology / Microbiology.

Competencies

• A working understanding of the QC Microbiology laboratory environment, aseptic technique, cleanroom behavior, and familiarity with all basic and complex laboratory equipment / instrumentation.
• Understanding and following written SOPs, recording all work legibly and in real time, and maintaining close attention to detail.
• Knowledge of GMPs and their application in the environment.
• The ability to organize work on a routine basis and require minimal supervision.
• The ability to provide updates and track tasks.
• The ability to communicate verbally and in writing.
• The ability to troubleshoot assays and instruments in area of expertise and offer solutions.