QC Microbiology I

The QC Analyst Microbiology will have several responsibilities in the QC group.  The analyst will perform environmental monitoring (EM) for particulates and viables in support of cGMP manufacturing which includes several production suites of ISO class 5, 7, and 8 as well as 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 of data, report writing, and trending of data; investigations, gowning training and annual gowning qualification.

• Perform environmental monitoring for HVAC (viable air, viable surface, total particulates), personnel monitoring, purified water (conductivity, TOC, bioburden).
• Perform entry of data 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 conductivity, TOC, bioburden, endotoxin, growth promotion, etc.
• Perform QC Laboratory testing accurately and to schedule as per written procedures. Record all data, observations and QC results accurately with attention to detail.
• Order and maintain laboratory reagents and supplies.

•Perform other tasks as required or assigned.

• B.A. or B.S. degree in microbiology, biology or related scientific field
• A minimum of 1-2 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

• Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
• Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that “negotiable” is neither salary nor requirements. Salary commensurate with experience.