Immunology Quality Control Specialist

POSITION SUMMARY:

The incumbent will monitor and document immune assays and analysis of epidemiological and clinical trials samples. The immune assays are applied in TB vaccine clinical trials to measure the immunogenicity of vaccines, and to define the immunological correlates of protection. The incumbents’ major responsibilities will be in the area of epidemiological and clinical sample logistics, assays, analyses, data management and documentation.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The incumbent will be expected to know all lab procedures, conduct QC procedures, and address problems, such as, but not limited to:
•Ensure proper performance and documentation of validated clinical CMI assays for epidemiological and clinical vaccine studies
•Conduct and document routine laboratory maintenance, including reagent inventory, calibration and certification of materials and equipment, and facility monitoring under GCLP conditions
•Assist in coordination of sample analyses and assay runs in the Aeras laboratories, and support data collection and tracking of laboratory results into data base.
oUsing tracking systems and other tools, develop prospective systems to ensure sufficient stocks of reagents in inventory.
oPerform electronic archiving activities for all epidemiological and clinical studies and associated tasks for CMI and serological assays and procedures.
•Conduct reviews of regulatory documents to ensure compliance with FDA regulations/guidelines, ICH GCP guidelines and standard operating procedures. Work closely with QA department and Project Manager to ensure timeliness and regulatory compliance for studies.
•Assist in audits, and inspections of GCLP operations.
oAssist in establishing protocols for handling audits and inspections.
oDevelop system to track and address findings.
oAssist in developing proper closure plans for audit findings.
•Assist the in the further development of processes regarding shipping, receiving, recording, storing and data management of all epidemiological and clinical trial samples
oSupport LIMS configuration process and implement clinical immunology part; incorporate FreezerWorks database
oIn collaboration with preclinical, epidemiological and clinical development and data management, develop tracking, specimen bar-coding and labeling systems using appropriate software to ensure the quality of biological specimens moving from preclinical, epidemiological and clinical trial sites to Aeras laboratories or other contract facilities.
•Support drafting methods, procedures, validation reports and other GMP documentation as needed for department, IND and FDA filing.
REQUIREMENTS
QUALIFICATIONS AND REQUIREMENTS:

•Master’s Degree in Science (immunology, cell biology, or biochemistry) or Bachelor’s Degree in Science with minimally four years related experience and/or training; or equivalent combination of education and experience with at least three years of relevant industry experience, enabling to supervise and perform daily activities in a GCLP environment under FDA compliant industry standards or experience in clinical trials are preferred.
•Knowledge of EMEA and ICH regulations and FDA guidance is a plus
•Incumbent should be able to use LIMS compatible software for data analyses and documentation required in vaccine trials.
•Advanced skills in Microsoft and related computer software, specifically communication, flow charts, and data documentation are required.
•Individual must have excellent interpersonal/communications skills, extremely good organizational skills, and the ability to perform multiple tasks during a single work day.