The QC Microbiologist II will have several responsibilities in the QC group. The analyst will perform environmental monitoring (EM) for particulates and viable samples in support of cGMP manufacturing. This includes several production suites of EU Grade A to D in a GMP facility that produces biopharmaceuticals (vaccines, biologics, viral vaccines, monoclonal antibodies, etc.). In addition, monitoring of purified water, and compressed gases systems is required. Additional responsibilities may include EM data review and compilation and verification of data, report writing, and trending of data, gowning training, annual gowning qualification and quality record assistance.

Responsibilities:

• Perform environmental monitoring for HVAC (viable air, viable surface, total particulates, personnel monitoring).
• Perform purified water sampling and testing (conductivity, TOC, bioburden).
• Perform entry of data or data verification, as needed into EM database. Assist in generation of quarterly and annual trend reports.
• Participate in visual inspection program of final products as part of fill-finish activities.
• Perform sample log-in, assignment of accession numbers and coordinate shipment of samples to outside test labs.
• Perform microbiological testing such as endotoxin, growth promotion, etc.
• Perform QC Laboratory testing accurately, according to schedule, and as per written procedures. Record all data, observations, and QC results accurately with attention to detail.
• Cross train for production inspection and packaging activities.
• Order and maintain laboratory reagents and supplies.
• Assist or lead quality record completion (OOS, EM investigations, deviations, change control, CAPAs).
• Other duties as assigned
• Vaccination in support of upcoming projects.

• Bachelor’s degree in microbiology, biology or related scientific field
• A minimum of 3 years related experience with biological products, in a GMP Quality Control laboratory.
• Experience performing EM, purified water sampling and testing
• Experience with bioburden endotoxin, TOC and conductivity a plus.
• Requires excellent written and verbal communication skills.
• Computer (PC) and software skills including MS Office Suite Excel and Word programs.
• Must have experience with cGMP and quality systems including OOS and EM investigations, deviations, change control and CAPAs.
• High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.
• Demonstrated ability to work independently as well as be a strong team contributor
• Strong communication
• Takes initiative
• Works well with all types of people
• Remains calm under pressure