BioStem Life Sciences' Quality Assurance team is committed to ensuring that all operations within our facility meet the highest quality standards outlined in our Quality System. Our team of QA specialists make certain that both production and final product output are in compliance with FDA and other regulatory agency requirements.
Review/approval of documents associated with all phases of cGMP production including
Standard Operating Procedures
Master Production/Control Records
Batch Production Records
Certificates of Analysis
Oversight of Raw Materials including acquisition and release of materials used in production lots
Review of QCS testing and release of manufactured final product
Issuance and control of GMP documentation
Management of raw materials and batch record archives
Maintenance of training files for all BioStem personnel
Oversight of equipment calibration/maintenance and associated documentation archives
Oversight of facility maintenance/cleaning and associated documentation logs
Oversight of IQ, OQ and PQ executions for equipment related to GMP work
Surveillance of vendors and out-sourced services, specifically execution of audits (on-site and by mail) of suppliers and contract testing laboratories
Primary contact for internal audits requested by potential clients including interacting with auditor(s) throughout the process and ensuring a timely response to all resulting observations
Investigations and CAPAs
Oversight of internal investigations including assigning, monitoring and approving CAPAs with the goal of a thorough and timely completion, as well as adequate close-out and effectiveness
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If you have questions about the company, our lab, our scientific team or anything else, please feel free to contact us.