Microbiologist - Compounding Pharmacy

Chewy is seeking a highly skilled and experienced Microbiologist to join our Compounding Pharmacy team in Pittston, PA! 

The ideal candidate will possess extensive knowledge and expertise in microbiological testing, environmental monitoring, and aseptic techniques within ISO-classified environments. The Microbiologist is responsible for ensuring the sterility and safety of our compounded pharmaceuticals, maintaining compliance with regulatory standards, and encouraging a culture of quality and safety within the compounding pharmacy. 

What You'll Do 

• Serve as a critical member of the compounding pharmacy quality department  

• Coordinate analytical testing with 3rd party analytical labs for sterile and non-sterile compounds. 

• Perform in-house endotoxin testing. 

• Perform viable and non-viable sampling in compounding suite, track, and trend environmental monitoring data, and report microbial recoveries. 

• Develop surveillance program to monitor overall hygiene of facility. 

• Operate aseptically within ISO-classified controlled environments, ensuring compliance with USP standards. 

• Investigate non-conformances, conduct root cause analysis, and implement corrective actions. 

• Participate in internal and external audits to maintain compliance with regulatory standards. 

• Maintain certification, calibration, and validation of sterile suite equipment. 

• Train and supervise QC Technicians and other staff on Good Laboratory Practices, creating and administering training content. 

• Work closely with the leadership team, QA managers, and cross-functional teams to drive improvements in environmental controls and processes. 

• Maintain accurate and detailed records of all testing, environmental monitoring, and quality events. 

• Review batch records for accuracy as part of quality-related event investigations. 

• Develop and review SOPs to ensure compliance with USP 797 for the purpose of sterility testing, aseptic qualification of compounding staff, surface sampling for microbial and hazardous drugs. 

• Initiate and complete remediation plans for actionable events. 

• Other duties assigned based on business need 

What You'll Need 

• B.S. in Microbiology or related field. 

• Certified Quality Technician (CQT) from the American Society for Quality (preferred). 

• Proficiency in quality system management, cleanroom aseptic technique, culture-based microbiological lab techniques, microscopy, FTIR, endotoxin testing, sterility testing, environmental monitoring, data trending, root cause analysis, CAPA, technical writing, developing and reviewing SOPs, and familiarity with Microsoft 365, Google Drive, and various QMS, LIMS, and EMS interfaces. 

• Experience managing quality assurance programs for testing laboratories, conducting internal audits, and maintaining compliance with ISO 17025 and other regulatory standards. 

• Experience in sterility testing of pharmaceuticals or compounded preparations, environmental monitoring in clean rooms, and training laboratory staff. 

• Proven record of accomplishment in developing and driving environmental monitoring programs, improving environmental controls, overseeing quarantine and release/rejection of goods, and promoting workplace safety. 

• Must be able to wear PPE for long periods of time when needed. 

• Able to stand for extended periods of time, walk up to 2 miles per shift, and lift 25 pounds either with or without reasonable accommodations. 

• Compounding Team Members may be exposed to hazardous chemicals used in the preparation of compounds (some are classified as hazardous and/or toxic by the National Institute for Safety and Health and special safety precautions must be taken when working with these chemicals). 

• This position will require periods of sitting, standing, squatting, kneeling, reaching and walking  

• Must be able to use hands to handle, control, or feel objects, tools, or controls