Title:  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 environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

*Eligibility 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