Quality Manager - Compounding Lab

Quality Manager - Compounding Lab

24 Sep 2024
Pennsylvania, Pittston, 18640 Pittston USA

Quality Manager - Compounding Lab

Our Opportunity:Chewy is seeking an experienced and dedicated Quality Operations Manager to join our compounding pharmacy team! You will be responsible for implementing and leading site-level processes to monitor and control the quality performance of equipment, facility environment and systems, and personnel training and qualification. This role is crucial in ensuring continued conformance with the company’s quality and compliance policies. The Quality Manager will lead a quality culture that supports the Chewy's values of customer focus, integrity, and innovation through continuous collaboration with other functional areas.What you’ll do :

Environmental Monitoring: Manage and/or implement viable and nonviable environmental monitoring, sanitary conditions audits, mechanical system monitoring (water systems, HVAC systems), and pest control monitoring.

Equipment Qualification: Manage and/or implement initial qualification of equipment (IQ/OQ/PQ), ongoing calibration, validation, and requalification of equipment performance, and audits of equipment cleanliness.

Process Verification: Manage initial and on-going effectiveness verification of processes, equipment, and supplies associated with facility and equipment cleaning and/or disinfection.

Sterilization Processes: Manage initial and on-going verification of sterilization processes, personnel, and equipment.

Personnel Qualification: Manage processes for the initial and on-going verification/qualification of personnel.

Documentation: Manage the processes for creating or modifying documentation and recordkeeping of any of the above functions, including Standard Operating Procedures (SOPs). Develop and negotiate vendor quality agreements

Nonconformance Investigations: Manage the execution of investigations into any nonconformances/OOSs associated with any of the above functions.

Mitigation Actions: Determine and manage the execution of any immediate actions/control measures needed to mitigate quality or regulatory risk associated with nonconformances/OOSs. Participate in audits and inspections.

CAPA Plans: Approve CAPA plans prior to execution, monitor the progress of in-process plan execution, and determine/document when CAPA has been fully implemented.

Continuous Improvement: Proactively find opportunities for improving quality, compliance, and efficiencies within the processes associated with the above functions.

Chewy is committed to equal opportunity. We value and embrace diversity and inclusion of all Team Members. If you have a disability under the Americans with Disabilities Act or similar law, and you need an accommodation during the application process or to perform these job requirements, or if you need a religious accommodation, please contact CAAR@chewy.com .If you have a question regarding your application, please contact HR@chewy.com .To access Chewy's Customer Privacy Policy, please click here (https://www.chewy.com/app/content/privacy) . To access Chewy's California CPRA Job Applicant Privacy Policy, please click here (https://chewyinc.phenompro.com/us/en/privacy-policy) .

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