Quality Control Analyst II

Position Summary
The QC Microbiology Analyst Il 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

• Follow written procedures for the following tests, bioburden, endotoxin, microbial identification growth promotion
• Support other activities as needed, such as Environmental Monitoring of controlled clean rooms, product qualification s 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, labels log and inventory laboratory supplies.
• 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

Qualifications

• Individual should have 2+ years of experience in a QC Microbiology role. Experience in a biotechnology manufacturing setting is preferred.

Education
BS Degree in Microbiology or equivalent/higher is preferred.

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 a written format is required.
• The ability to troubleshoot assays and instruments in area of expertise, and to offer solutions, is expected.
  

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.