Microbiologist Compounding Pharmacy

Chewy isseekinga highly skilled and experiencedMicrobiologistto join our Compounding Pharmacy team in Pittston PA!

The ideal candidate willpossessextensive knowledge andexpertisein microbiological testing environmental monitoring and aseptic techniques within ISO-classified environments. The Microbiologist is responsiblefor ensuringthe sterility and safety of our compounded pharmaceuticalsmaintainingcompliance with regulatory standards and encouraging a culture of quality and safety within thecompounding pharmacy.

What Youll Do

• Serve as a critical member ofthe compounding pharmacy quality department

• Coordinateanalyticaltesting with 3rd party analytical labs for sterileand non-sterilecompounds.

• Perform in-house endotoxin testing.

• Performviableand non-viable sampling incompounding suite track and trend environmental monitoring data and report microbial recoveries.

• Develop surveillance program tomonitoroverall hygieneoffacility.

• 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 tomaintaincompliance with regulatory standards.

• Maintain certification calibration and validation of sterile suite equipment.

• Train and supervise QC Technicians and other staff onGood 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.

• Maintainaccurateand detailed records of all testing environmental monitoring and quality events.

• Review batch records for accuracy as part ofquality-related eventinvestigations.

• 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 Youll 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 andmaintainingcompliance with ISO 17025 and other regulatory standards.

• Experience insterility testingof 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 forlong periodsof 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 squattingkneelingreachingand walking

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