Job Details

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.
• Order, stock, receive, label, log, and inventory laboratory supplies.
• Provides laboratory support services, clean / maintain equipment, and prepare 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.
• Train other lab personnel
• May be qualified and assigned to review some laboratory data or documentation.

Qualifications

?    0-2 years of eqperience 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.

Education

Bachelor of Science or higher in Biology / Microbiology

Competencies

• The individual in this position is expected to have a working understanding of the QC Microbiology laboratory environment, aseptic technique, cleanroom behavior, and be familiar with all basic and complex laboratory equipment / instrumentation.
• This position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary.
• Good knowledge of GMPs and their application in the environment is required.
• The individual in this position will be able to organize his /her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/ her tasks.
•  The ability to communicate verbally and in written format is required.
•  The ability to troubleshoot assays and instruments in area of expertise, and to offer solutions is expected.