Microbiology - Internship

GVS S.p.A.; Northern (KY); On-site; USD 40,000 - 60,000; Full time

Job summary

Elisa Industriq France is seeking an entry-level QC/Analytical Technician to monitor environmental systems, perform microbial analysis, water testing, and environmental testing. You will record results, support growth and quality inspections, and ensure compliance with quality standards.

Responsibilities include maintaining lab equipment, managing inventories, and developing and maintaining laboratory procedures while adhering to FDA 21 CFR 820 and ISO 13485 standards.

Responsibilities

• Monitor environmental systems and perform microbial analysis, water testing, and environmental testing.
• Record and report test results; support microbial growth and promotion activities; conduct quality inspections per procedures to ensure quality standards.

Job description

• This position supports Production, Facilities, Engineering, and Quality by monitoring environmental systems and performing microbial analysis, water testing, and environmental testing. Responsibilities include recording and reporting test results, supporting microbial growth and promotion activities, and conducting quality inspections according to established procedures to ensure compliance with quality standards.

Must be flexible to work from 8:00 am to 3:30 pm.

Conduct Quality Control (QC) testing of products, facilities, and critical systems. Perform entry-level analytical method development and R&D activities, while supporting general and research projects.

Perform quality inspections according to established procedures and /or work instructions.

Maintain laboratory equipment, facility systems, etc.

Maintain inventory of supplies and equipment.

Perform accurate and compliant data and record management.

Develop and maintain laboratory procedures.

Learn relative regulations. Train, understand, and perform assays according to procedures and regulations. Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Develop, write, update and review laboratory SOP’s for various microbiology procedures in compliance to USP, ISO and AAMI standards.

Support sterilization validation and dose audits for new and existing products utilizing Ethylene Oxide and gamma radiation sterilization methods by using biological indicators, LAL Endotoxin Chromogenic testing, sterility procedures and B&F following USP 71.

Check inventory for lab equipment and supplies, including sending equipment for calibration and ordering biologics and supplies for micro testing.

Assist on stability studies for anticoagulation products for real and accelerated time periods and writes protocols and reports.

Will demonstrate proficiency in Aseptic Process Environmental Monitoring, Aseptic Testing, Microbial Monitoring, Gram Staining, Subculturing, Bacterial Endotoxin Testing, Bioburden Testing, Membrane Filtration, Growth Promotion, Gram Staining and other USP and ISO testing.