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

Location:

Dayton, NJ, US, 08810

Nearest Major Market: New Jersey