QCM Lead Scientist

Job Code:

Q1033

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Post Date:

October 10, 2021

JOB DESCRIPTION

The Lead scientist will assist QC management on creating the Quality Documents needed to start the QC lab and Environmental Monitoring department. Once we start running, the lead will help with scheduling, training, and act as a leader within the QCM group.

RESPONSIBILITIES

  • Assist Quality Control Microbiology Supervisor in daily activities and scheduling of QC and EM personnel.

  • Responsible for assisting Quality Control Microbiology Supervisor in the creation of all Quality Control Microbiology quality systems and implementation of those systems.

  • Carry out Quality Control testing and Environmental Monitoring of clean rooms for Client specific processes.

  • Perform routine inventory.

  • Observe and report any safety issues.

  • Author and review procedures and documents as needed.

  • Participate in cleaning and process validation activities involving microbiology.

  • Collaborate with cross-functional teams to resolve complex method development challenges.

  • Develop and train QC Microbiology and EM personnel.

  • Perform investigation of microbiological data deviations and OOS/OOT.

  • Perform investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.

  • Responsible for participation in internal audits, client audits and agency inspections of the site which includes the satisfactory execution, follow up, and closure of inspection and audit items to the satisfaction of all parties. 

  • Lead, develop, perform, troubleshoot, and optimize microbial assays including but not limited to qPCR, endotoxin, sterility, bioburden, environmental monitoring, particulate matter, mycoplasma testing, organism identification, and growth promotion.

  • Perform gowning qualifications and re-qualifications for personnel needing access to classified manufacturing areas.

  • Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including oversight of cGMP sample handling, testing, QC release and stability data analyses and method data trending, deviations, out of specification investigations, and Certificates of Analysis creation.

  • Participate in method qualification and validation, transfer, and testing.

  • Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure Quality Control functions remain in compliance with applicable company requirements and global regulations.

  • All other duties as assigned.

QUALIFICATIONS

  • BS/BA or greater in sciences, preferably in microbiology, biology, biotechnology, pharmaceutical sciences, or related technical field.

  • 5+ years related GMP experience in biotechnology, microbiology, environmental monitoring, pharmaceutical, manufacturing, or laboratory environment.