Quality Control Analyst Biotechnology Manufacturing 602

Company Name:
MedTeam Staffing
This is a contract job opportunity
Position: Quality Control Analyst Biotechnology Manufacturing 602
Location: Bogart GA
Projected duration: 7 months
Job code: 602
Position Description
The QC Microbiology 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, in process, and bulk drug substance and additionally support internal activities of QC Microbiology.
Follow written procedures for the following tests
bioburden, endotoxin, microbial identification, growth promotion
Support other activities as needed, such as TOC, Conductivity, Hardness, Chlorine, Environmental Monitoring of controlled clean rooms, Utility Monitoring, product qualifications and investigations.
Write and review SOPs, deviations, CAPA, change controls and technical investigations and reports as assigned.
Recognize aberrant test and sample conditions and report to them to the area supervisor / manager with an assessment of the circumstances and potential corrective action if appropriate.
Write and compile investigation documentation.
Maintain knowledge of current scientific principles and theories and train other lab personnel as assigned in areas of competence.
Order, stock, and receive, label, log and inventory laboratory supplies. Maintain reference standard inventory to support area testing.
Provide laboratory support services, clean/maintain equipment and prepare reagents/solutions.
Perform all job functions in compliance with cGMPs and maintain accurate and legible laboratory records.
Ensure training is current for all job functions performed.
Attend all required Company training.
Train other lab personnel.
May be qualified and assigned to review some laboratory data or documentation
Individual should have 0-2 years of experience in a QC Microbiology role.
Experience in a biotechnology manufacturing setting is preferred.
The individual in this position is expected to have a basic 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 with general supervision. When asked, the individual is able to provide updates and tracking on his/her tasks.
The ability to communicate verbally and in a written format is required.
A BS in Microbiology or higher is preferred.

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