Analyst II, Quality Control (QC) Microbiology – East Norriton, PA

General Company Description

My client is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. This position will report to the Sr. Manager of QC Microbiology.

Position Summary & Role

My client seeks an Analyst II, QC Microbiology, supporting the Microbiology department of QC. The successful candidate will perform all tasks and procedures related to the environmental monitoring program and microbiological testing in support of the Manufacturing areas at the company, supporting in viable and non-viable sampling, quality control testing and data analysis.

The QC Micro Analyst II will partner and collaborate with Manufacturing and QC operations to ensure all required environmental monitoring and microbiological testing activities and requirements are performed, meeting partner needs and complying with standard operating procedures.

Job Responsibilities

• Sample testing and analysis of Cell Therapy products using microbiological methods (rapid ATP detection, endotoxin detection, and mycoplasma detection by qPCR).
• Participate in method qualification/validation activities, as necessary.
• Assist and perform environmental monitoring activities including but not limited to routine and in process monitoring during productions, aseptic simulations, and environmental monitoring performance qualifications, as necessary.
• Observe and growth promote environmental monitoring plates in addition to media generated from Aseptic Process Validations.
• Analyze, document, and report experimental data in accordance with company’s requirements.
• Review GMP experimental data.
• Maintain and operate environmental monitoring and microbiology equipment.
• Maintain laboratory supplies.
• Other activities as assigned.
• Will require occasional early morning, late evening, and/or weekend work.

Preferred Experience, Education & Qualifications

• Minimum bachelor’s degree in relevant discipline (microbiology).
• 2 years of previous experience in a GMP environment.
• Ability to follow written and oral scientific directions.
• Demonstrated ability to work in a fast-paced team environment and meet timelines.
• Capable of multi-tasking and good organizational skills.
• Excellent attention to detail.