QC Analyst I – Environmental Monitoring

Bora Pharmaceuticals•Rockville, MD

1d•$60,000 - $75,000•Onsite

About The Position

This position is responsible for performing activities in support of microbiology and environmental monitoring testing programs including monitoring of the manufacturing cleanrooms. This individual will be required to complete the testing and related documentation in a timely manner while adhering to standard operating procedures and under cGMPs.

Requirements

High School Diploma and minimum of one year experience in performing Environmental Monitoring and Microbiology testing.
Bachelor’s Degree in scientific discipline
Working knowledge of good in performing Environmental Monitoring or Microbiology testing.
Needs to be able to follow directions that are outlined in SOPs and other quality guidelines.
Ability to organize daily activities to meet internal customer needs in a fast-paced environment
Ability to understand when he/she should seek advice and guidance
Data entry skills

Responsibilities

Collects routine environmental monitoring (EM) samples and water samples and performs plate enumeration daily in accordance with all protocols and procedures.
Performs water testing and other routine microbiology testing in accordance with standard operating procedures.
Enters sampling and testing data into laboratory data system and ensures adherence to standard operating procedures and CGMP requirement.
Performs routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled and escalates potential equipment issues to supervisor.
Reports deviations and out of specification results from the sampling and testing to supervisor and assists with performing laboratory investigations to determine the root cause and possible resolution.
Revises and updates standard operating procedures, as assigned with guidance from senior analysts and/or supervisor.