QC Micro Specialist

As a QC Micro Specialist, a typical day might include the following: 

•  Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. 
• Implement verified methods for Endotoxin and Bioburden testing via Change Control, support Data Review and Compliance records as needed.
• Author protocols and Summary Reports for Bioburden, and Endotoxin verification as well as Low Endotoxin Recovery/Hold studies.
• Applies a fundamental understanding of the science behind the microbiological assays to perform advanced troubleshooting and complete complex microbiological investigations. 
• Leads tasks associated to aseptic process simulations. 
• Collaborate with team members on activities associated with Change Control. This includes initiation, impact and implementation of the change; also the initiation and closure of workflows and CAPAs. 
• Participate in the writing of technical documents and studies to troubleshoot and support investigations. 
• Applies their expertise in the creation and update of SOPs. 
• Lead data gathering and analysis in support of investigations and business decision-making. 
• Lead the evaluation of data entry, analysis, and reporting of microbiological data and support implementation of changes in order to identify streamlining opportunities. 
• Participates in internal audit discussions and seeks alignment with the team to address microbial requests. 
• Collaborates in technical discussions and problem-solving with outside entities (i.e. contract manufacturers and contract test labs) to drive resolutions. 
• Seek support to make good judgments and quick decisions regarding microbiological methods.  
• Assists in the integration of technical updates into the team procedures while maintaining compliance with regulatory agencies. 
• Implements the creation and review of LIMS configurations to meet the needs of QC-Microbiology, this may include implementation of new specifications, design of LIMS/ELN templates for new/revised test methods, design of queries and reports. 
• Assists in the collection and maintenance of reference libraries for microbiological methods. 

This role might be for you if you:  

• Can facilitate with organizational agility.
• Assist in the development and support of strategies on how to achieve what needs to be done and develops metrics to measure the strategy. 
• Have advance Knowledge in Microbiological Test Methods (This includes, but is not limited to: Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) as