QC Specialist III - Microbiology

Role Summary

Conduct advanced microbiological research and testing to support QC Micro projects. This role involves equipment qualification, development and validation of Microbiology methodologies, analyzing complex data, and ensuring compliance with regulatory standards. Self-led individual that works under only very general supervision to meet deadlines/goals.

Responsibilities

• Identify and drive continuous improvement projects to improve quality, service, reliability, delivery, and/or cost by enhancing microbiological testing and laboratory operations.
• Lead and provide project support for QC Microbiology, including microbiological assay validation, laboratory equipment qualification, and method improvement studies.
• Understand operations/processes to provide technical support to troubleshoot and resolve issues related to microbiological assays, instruments, and equipment.
• Author technical documents, protocols, and reports related to lab equipment qualifications, assay validations, and compliance-related studies as needed.
• Maintain and compile QC Microbiology metrics including trend reports as needed (e.g., environmental monitoring).
• Perform or review gap assessments for QC Microbiology to align with Global standards and regulatory requirements.
• Maintain applicable QC Microbiology SOPs to ensure compliance with FDA guidelines, QSR, cGMP, and other regulatory standards and drive procedural improvements.
• Support internal and external audits (e.g., FDA, Corporate Quality Assessments) by ensuring compliance with procedures, guidelines, and regulatory requirements.
• Serve as a subject matter expert and point of contact during inspections, providing responses to inquiries and demonstrating compliance with regulatory requirements.
• Provide technical training and presentations to QC laboratory staff, including management, to ensure understanding of microbiological testing procedures and compliance.
• Lead or actively contribute to team initiatives that enhance efficiency, cost savings, quality improvements, and problem-solving.
• Proactively identify training needs, ensure personal training requirements are met, and maintain training records for laboratory personnel.
• Stay current in the technical and compliance fields related to lab instruments, microbiological methods, and industry best practices.
• May perform other duties as assigned.

Qualifications

• Strong knowledge of cGMP, QSR, USP, CFR, and other regulatory requirements.

Education

• Bachelor's degree in science, engineering or related technical field; 3+ years of related experience. Preferred: Bachelor's Degree in Chemistry or Biological Science.

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.