QC Micro EM Specialist

Job Introduction

The QC Environmental Monitoring Specialist will support the Environmental Monitoring Program in the GMP Quality organization.

The Environmental Monitoring Specialist will ensure that all aspects of environmental sampling and testing associated with utilities and classified areas are within established alert and action levels.

Role Responsibility

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

Perform routine Environmental Monitoring (EM) of surface, viable and non- viable air, settling plates in Classified areas.
Perform routine Environmental Monitoring (EM) of surface and room air in Non-classified areas.
Participate in media fills and product fills which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity.
Sample and read EM and assess per specifications as appropriate.
Review raw data and enter results using Laboratory Information Management System (LIMS).
Incubate and enumerate organisms on cultured media.
Perform compressed gas sampling and testing.
Perform microbial isolation techniques, gram stains, and support microbial identification process.
Perform sampling and bioburden testing of In-process, Water for Injection (WFI), Purified Water, and City Water samples.
Perform LAL testing of Water for Injection (WFI), Raw Materials, Final Product using Gel-Clot method.
Perform Sterility Testing of Release and Stability samples.
Documentation of results in accordance with current Good Manufacturing. Practices (cGMP).
Coordinate with manufacturing on scheduling of EM sampling.
Support of EM process validation and EM equipment qualifications.
Responsible for preparing and maintaining media inventory. Ensure that media used for environmental monitoring passes growth promotion testing prior to use.
Ability to aseptically gown and work in a sterile work environment.
Flexibility in following work schedule requirements that may include off-hour and weekend work.
Ability to read, understand and follow SOPs.
Monitoring temperatures of incubators and refrigerators.
Track and trend EM data including Microbial identification results in support for product release.
Provide input on SOP revisions and may assist in the creation and editing of protocols.
Participate and write Deviation, OOS, CAPA’s and alert investigation.
Order laboratory supplies as needed.
Ability to stand for a long period of time.
Ability to lift 25 lbs
May perform other general laboratory duties as assigned.

The Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:

A minimum Bachelor’s degree in Microbiology or Biology discipline is preferred and + 1 year of EM experience in a pharmaceutical/biotech industry or
Associate degree with +3 years EM experience in a pharmaceutical/biotech industry.