Job Description
- 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
- 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.
- 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.
- Bachelor of Science or higher in Biology / Microbiology
- 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.
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