Aseptic Technician

Job Purpose

Perform functions within the Microbiology Laboratory related to Environmental Monitoring of controlled production areas. The duties also include equipment maintenance and LIMS management.

Key Accountabilities

Perform routine daily, weekly, and monthly environmental monitoring for controlled areas (ISO5, ISO7, and ISO8). Prepare personnel and room plates daily. Perform personnel and room batch level environmental monitoring sampling. Perform daily cleanroom exit monitoring sampling. Request and drop off RODAC and TSA environmental monitoring plates required for compounding department on daily basis. Perform controlled area recovery sampling following shutdown activities through a DCE request. Perform gowning qualification and re-qualification sampling for cleanroom personnel. Regular and predictable onsite attendance and punctuality. Ensure Environmental Monitoring (EM) of the facility’s controlled areas is performed as required. Document EM testing into the EM database prior to incubation, ensure samples are correctly incubated, and record sample results in the EM database following incubation. Compile trending data for EM testing to support investigations. Audit personnel aseptic technique in controlled areas including during process simulations (media fills). Author laboratory event and investigation reports. Communicate issues between departments as appropriate. Communicate effectively with co-workers to ensure all required tasks are completed as expected. Document test data clearly and accurately. Maintain data integrity and ensure compliance with company policies, procedures, cGMPs, and regulatory requirements.

Qualifications

Minimum : 0-2 years pharmaceutical microbiology or environmental monitoring experience Must be able to pass and maintain Class 100/ISO 5/Grade A gowning qualification.

Experience & Skills

Must be able to lift 20 lbs. Ability to handle multiple tasks concurrently and complete tasks in a timely fashion Computer literate Must be able to communicate effectively across all departments and levels of management Understanding of laboratory instruments and methods Must have excellent writing skills to write clear and concise reports. Knowledge of pharmaceutical microbiological methods and cGMPS as well as an understanding of scientific principles preferred.

What We Offer

Clean climate-controlled working environmentAnnual performance bonus potential401k employer match up to 6% of your contributions23 vacation/personal days11 paid Company holidaysGenerous healthcare benefitsEmployee discount programWellbeing rewards programsSafety and Quality is a top organizational priorityCareer advancement/growth opportunitiesTuition ReimbursementMaternity and Parental LeaveEligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms