Quality Lab Associate I, Env. Monitoring - 2nd Shift

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

 

• 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.
• BS/BA Degree in Microbiology or Biology with 0-2 years
• pharmaceutical microbiology experience. Microbiology coursework and laboratory work utilizing aseptic technique is required.
• Must be able to pass and maintain Class 100/ISO 5/Grade A gowning qualification
• 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.
• Must have 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
• Paid time off
• Company holidays
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities

 

*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