QC Analyst II - Environmental Monitoring

Role Summary

This position is responsible for performing activities in support of the 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.

Responsibilities

• Collects routine environmental monitoring (EM) samples and water samples on a daily basis in accordance with all protocols and procedures.
• Conducts microbiology testing such as Bioburden, Endotoxin, and TOC for raw materials, in-process, and final formulation samples in accordance with standard operating procedures.
• Conducts plate enumeration and microbial identification as needed.
• Enters and reviews data into laboratory data system to ensure data integrity and adherence to standard operating procedures and GMPs.
• Ensures lab equipment is calibrated and maintained as required for testing per standard operating procedures.
• Reports “out of specification” results from sampling and testing to supervisor and assists with performing laboratory investigations.
• Revises and updates standard operating procedures, as needed.
• May perform special projects related to problems encountered with microbial testing and instruments and make recommendations for solutions that will minimize future issues.

Qualifications

• Experience in one or more of the following areas required: Environmental Monitoring, Quality Control, Microbiology, and/or GMP production.

Skills

• Working knowledge of good laboratory practices.
• Ability to work independently on assigned methods and follow procedures.
• Ability to organize and prioritize daily activities to meet internal customer needs in a fast-paced environment.
• Ability to resolve problems independently and responsively.
• Be able to work in a team environment in a cooperative and respectful manner.
• Ability to stand for periods of time when performing tasks on the floor.
• Ability to work a varied schedule including off shift and weekends.

Education

• High School Diploma and minimum of three years of experience in performing Environmental Monitoring and Microbiology testing.
• Associate’s degree in a scientific area of study with two years of related experience;
• Bachelor’s Degree in a scientific discipline and minimum of two years’ related experience

Additional Requirements

• Ability to lift up to 50 pounds.