Specialist QC

Role Summary

The Specialist, Quality Control Microbiology leads Environmental Monitoring and Utilities Monitoring programs to support the drug substance manufacturing facilities. The role reports to the Senior Manager of Quality Control Microbiology and may supervise a small team. This position ensures regulatory compliance, data integrity, and risk-based decision making across EM, contamination control, and related QC activities in a GMP environment.

Responsibilities

• Provide site-level leadership and strategic ownership of Environmental Monitoring (EM) and Utilities Monitoring programs, ensuring sustained compliance, data integrity, and a proactive state of control across manufacturing operations.
• Serve as the primary subject matter expert (SME) for environmental monitoring, utilities monitoring, and contamination control, providing expert guidance to site leadership, cross-functional partners, and global stakeholders.
• Establish, oversee, and continuously improve monitoring strategies, including data review, trend analysis, interpretation and presentation to support risk-based decision making.
• Author, review, and approve GMP documentation and technical deliverables, including SOPs, safety assessments, trend reports, qualification and validation summary reports, microorganism assessments, and other technical reports.
• Lead the planning and execution of Environmental Monitoring Performance Qualification (EMPQ) activities in support of facility changes, expansions, and new initiatives, partnering closely with QC Micro Sampling and Testing teams.
• Provide technical oversight and governance for Clean Utilities qualification activities, ensuring alignment with regulatory expectations and internal quality standards.
• Drive cross-functional alignment with Manufacturing, Facilities & Engineering, Quality, and other stakeholders to ensure monitoring programs support both compliance and business objectives.
• Drive the site Contamination Control Strategy, participating in contamination risk assessments and ensuring effective implementation, monitoring, and continuous improvement in alignment with global standards.
• Represent the site in global environmental monitoring and contamination control forums, influencing best practices, sharing expertise, and driving harmonization across the network.
• Deliver clear, data-driven communication to site leadership, including routine presentations on environmental and utilities monitoring performance, risks, trends, and mitigation strategies.
• Lead and support regulatory inspections, internal audits, and cross-functional initiatives of site or global scope, serving as a technical authority during audits and inspections.
• Support QC Microbiology laboratory investigations and deviation investigations, ensuring timely resolution, robust root cause analysis, and sustainable corrective and preventive actions.
• Provide operational leadership and escalation support for routine monitoring activities, including coverage during weekends and public holidays as required to maintain compliance and operational readiness.
• Schedule and coordinate routine or qualification activities with manufacturing operations as needed.

Qualifications

• Required: High school diploma / GED and 10 years of Quality or Aseptic Manufacturing experience OR
• Required: Associate’s degree and 8 years of Quality or Aseptic Manufacturing experience OR
• Required: Bachelor’s degree and 4 years of Quality or Aseptic Manufacturing experience OR
• Required: Master’s degree and 2 years of Quality or Aseptic Manufacturing experience
• Preferred: Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
• Preferred: Degree in Microbiology, Biology, Biochemistry, or related scientific field.
• Preferred: Experience with environmental monitoring and clean utilities monitoring, including execution of EMPQ and trending of EM/utilities data.
• Preferred: Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC.
• Preferred: Experience with regulatory inspections.
• Preferred: Strong knowledge of aseptic technique.
• Preferred: Strong written and verbal communication skills, including technical writing and technical presentations.
• Preferred: Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer.