Eurofins
Senior Microbiology Specialist
QC SME
Eurofins PSS is hiring a Senior Microbiology Specialist
QC SME to support pharmaceutical quality control operations at a client site. This is a hands-on role for someone with deep expertise in microbiology who can work independently and serve as the go-to resource for microbiology-related questions and processes. While this is not a leadership position, there is potential to grow into a leadership role over time. What You'll Do Perform sterility, endotoxin, pH, and osmolality testing on raw materials and drug products. Conduct gram stains, growth promotion testing, and cell culture work. Lead aseptic process media fills and related testing (e.g., visual inspection). Carry out environmental monitoring (air, surfaces, personnel, particulates) in cleanrooms. Keep lab equipment clean and maintained; ensure documentation is complete and compliant. Write and update SOPs, change controls, and qualification protocols. Investigate out-of-specification (OOS) results and non-conformances; identify root causes and implement corrective actions. Perform internal audits and walk-throughs to ensure compliance. Collaborate with Manufacturing, QA, and Facilities teams to meet production goals. Train other lab staff as needed. Develop and validate new microbiological testing methods to improve efficiency and accuracy. Participate in risk assessments related to microbial contamination and product safety. Analyze trends in microbiological data and prepare comprehensive reports for management review. Serve as a subject matter expert during regulatory inspections and customer audits. Contribute to continuous improvement initiatives by proposing and implementing process enhancements in the microbiology lab. What You Need to Know Sterility and endotoxin testing USP standards Growth promotion and gram staining Environmental monitoring in pharma settings Aseptic process media fills cGMP and Good Documentation Practices Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global, award-winning insourcing solution that places our people at our clients' sites, dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries. To learn more about Eurofins Lancaster Laboratories, please explore our website.
QC SME
Eurofins PSS is hiring a Senior Microbiology Specialist
QC SME to support pharmaceutical quality control operations at a client site. This is a hands-on role for someone with deep expertise in microbiology who can work independently and serve as the go-to resource for microbiology-related questions and processes. While this is not a leadership position, there is potential to grow into a leadership role over time. What You'll Do Perform sterility, endotoxin, pH, and osmolality testing on raw materials and drug products. Conduct gram stains, growth promotion testing, and cell culture work. Lead aseptic process media fills and related testing (e.g., visual inspection). Carry out environmental monitoring (air, surfaces, personnel, particulates) in cleanrooms. Keep lab equipment clean and maintained; ensure documentation is complete and compliant. Write and update SOPs, change controls, and qualification protocols. Investigate out-of-specification (OOS) results and non-conformances; identify root causes and implement corrective actions. Perform internal audits and walk-throughs to ensure compliance. Collaborate with Manufacturing, QA, and Facilities teams to meet production goals. Train other lab staff as needed. Develop and validate new microbiological testing methods to improve efficiency and accuracy. Participate in risk assessments related to microbial contamination and product safety. Analyze trends in microbiological data and prepare comprehensive reports for management review. Serve as a subject matter expert during regulatory inspections and customer audits. Contribute to continuous improvement initiatives by proposing and implementing process enhancements in the microbiology lab. What You Need to Know Sterility and endotoxin testing USP standards Growth promotion and gram staining Environmental monitoring in pharma settings Aseptic process media fills cGMP and Good Documentation Practices Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global, award-winning insourcing solution that places our people at our clients' sites, dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries. To learn more about Eurofins Lancaster Laboratories, please explore our website.