Quality Lab Associate I, Env. Monitoring
Location
Cherry Hill, NJ, USA
Remote/
On-site
On-site
On-Site
Department
Other
Type
Full Time
Salary
Job Description
Posted on:
December 6, 2023
Perform functions within the Microbiology Laboratory related to Environmental Monitoring of controlled production areas. The duties also include equipment maintenance and LIMS management.
Responsibilities
- 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.
Job 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.
