QC Microbiology -Associate

Title : QC Microbiology -Associate
Location : Norwood, MA

Duration: 6 months (Possibility of Extension)

Shift: Monday- Friday-2:00 pm to 10:00 pm

Job Description
Reporting to the Shift Supervisor of Quality Control (Microbiology), the Quality Control Associate II will support microbiological testing for GMP QC raw materials, excipients, drug substance, and finished product testing for mRNA products produced at Client's manufacturing facility and affiliated contract organizations. He/she may also support environmental and critical utility monitoring activities. This position will be from 2:00 pm to 10:00 pm working Monday through Friday.

Essential Duties

• Perform microbiological testing to include but not limited to the following: Culture Purity and Cell Stock Identity, Cell Density Determination, TOC and Conductivity Testing, Endotoxin, Sterility, Bioburden, Biological Indicator Analysis, Growth Promotion Testing, Microbial Identification using Vitek Maldi-TOF.
• Perform environmental and critical utility testing.
• Support testing for raw materials, intermediates, drug substance and drug product, including generation of testing data to support clinical studies
• Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
• May assist with equipment qualification / validation activities, including maintenance
• May troubleshoot issues related to equipment, laboratory procedures and assay performance
• Write/revise SOPs, technical protocols and reports
• Offer input and suggestions for improvement in laboratory operations and procedures
• Train and provide technical guidance to other microbiologists
  Education and Experience

• BS/BA degree preferred or at least 5 years' years relevant Quality Control experience in a cGMP organization with a focus in Microbiology
• Familiarity with relevant and current FDA, EU, USP, ICH guidelines and regulations
• Familiarity with Vitek®, Isolator Technology, Pyros Kinetix Flex Tube Reader, BacT and Milliflex Rapid Microbiology Systems and Isolator Technology preferred
• Experience in the execution of kinetic chromogenic endotoxin analysis, Sterility, Bioburden, and Growth Promotion Testing.
• Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment
• Excellent communication skills (verbal and written)