QC Microbiologist

Job Responsibilities:

• Participate as a key player in establishing the GMP QC Microbiology Laboratory.
• Partner with leadership in developing a world-class QC platform that will include a robust environmental monitoring program and laboratory processes that adhere to procedures and regulatory requirements for evaluating the microbiological aspects of drug products, excipients, and process materials. This includes, at a minimum, tests for sterility, endotoxin, and bioburden.
• Leadership role in partnering with program owners to develop PM and calibration plans to coordinate the upkeep, conformity, and IQ/PQ/OQ of instruments and the laboratory environment.
• Collaborate with the Quality Team on building a laboratory safety program to ensure a safe and quality-minded environment for all laboratory personnel.
• Perform microbiological testing required to support a state-of-the-art aseptic drug product manufacturing facility.
• Holds self and others accountable for rigorous scientific and quality work standards.
• Advocate for clients by collaborating cross-functionally to schedule microbiological sampling, testing, instruments, and personnel to meet customer needs and timelines.
• Maintain a constant state of safety and inspection-readiness in the QC laboratories. Use knowledge of quality principles, cGLPs, cGMPs, and regulatory standards to act as a key point-of-contact for regulatory agencies during inspections and audits.
• Support laboratory investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events.
• Utilize various paper and automated systems to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
• Use applied statistics to analyze and track test results to identify sources of variability and error in laboratory and manufacturing processes. Use data trends to apply a systematic approach to resolve technical issues, prevent errors, identify improvement opportunities, and implement continuous improvement plans.
• Maintain regulatory intelligence on the regulatory landscape, policies, and pharmaceutical industry trends through continuous education, networking, literature, trade organizations, etc.

Qualifications:

• 3+ years of microbiology, biology, or other related experience.
• B.S. in Biochemistry, Biology, or Microbiology
• Experience years have been in an aseptic drug products laboratory role.
• Design or use experience with LIMS (Laboratory Information Management Systems)
• Experience with Kaizen, Six Sigma, and/or Lean principles
• Experience in an isolator-based aseptic drug product manufacturing facility
• Project Management experience

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