Quality Control – mRNA Testing – GMP Quality Control – Raw Materials, Excipients, Drug Substance & Finished Products Manufacturing
Permanent and Contract to Hire Job Opportunities /Relocation may be available
Pay: $28 – $40+/hour
Hours: 1st/2nd/3rd shift
The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based medicines for evaluation in human clinical trials. He/she will support the handling and processing of materials within manufacturing operations in accordance with established processes and procedures. The successful candidate will be able to document and communicate their operational observations clearly and efficiently. They will be curious to learn and able to demonstrate a high degree of working flexibly.
The Role: Reporting to the Shift Supervisor of QC 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 the manufacturing facility and affiliated contract organizations. He/she may also support environmental and critical utility monitoring activities.
Here’s What You’ll Do:
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 E. coli cell bank testing
§ 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
Here’s What You’ll Bring to the Table:
BS in a relevant scientific discipline with at least 2 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
§ Experience in the execution of kinetic chromogenic endotoxin analysis, Sterility, Bioburden, and Growth Promotion Testing
§ Experience in testing cell lines
§ 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)