Bryan Arellanes

Experience

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  Baxter BioScience

  Jan 1999 - Jan 2005

  Perform compliance audits for 21 CFR 210, 211, 600, 601, 610, 820, EU, Health Canada, and ICH Q7A by collecting and analyzing accurate, objective evidence regarding risks and magnitude. Perform Supplier Audits of Analytical, Biological and Medical Device suppliers.Support Management and participate in external regulatory inspections.Participate on facility investigation teams surrounding product and process failures.Review validation protocols and facility exceptions for completeness and proper elevation.Receive and review items submitted to demonstrate completion of commitments to Regulatory Agencies, Corporate and Division, as well as internal audits.Lead cGMP Trainer for 600-person facility Certified Baxter BioScience Division Investigation Reviewer.Developed Metrics for QA and present said data during Management Review of Quality Systems.Maintain GMP training files, internal assessment files and provide detailed metrics.Prepare and maintain facility and department metrics.Created Access Database for tracking internal audit commitments. Show less

  • Quality Associate II / QA Compliance Liaison

    Jan 2002 - Jan 2005

  • Quality Control Specialist (Microbiology)

    Jan 1999 - Jan 2002
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  St. Jude Medical

  Oct 2005 - Dec 2014

  Mobilized workflows and compliance operations, developing and initiating process improvements to increase efficiencies. Implemented strategies to increase company metrics. Ensured employees possessed adequate trainings to support organizational needs. Shared ongoing feedback and ideas to fulfill operational functions and ensure compliance with regulations. Provided advice to executives pertaining to the regulatory climate. ► Accomplishment – Completed full re-validation and qualification of sterilization program within six months when previous system owner could not complete it after 24 months. Successfully passed inspection by FDA, European Union, Japan, et.al. on an inherited department that was out of compliance with Federal Regulations.► Accomplishment – Expanded team role to take on biocompatibility program. Show less Manage 40+ employees responsible for all aspects of Quality Control from Incoming to Final Release InspectionResponsible for Consignment Returns Inspection and dispositionProcess Owner for Servicing and Upgrade of external medical devices with full traceability and Quality System documentation of activitiesOversee maintenance of Device History Records including review, approval and archiving responsibilitiesQuality Representative and Facilitator for all Material Review Board activities including documentation of disposition, containment and risk assessmentQuality System Database Administrator (CATSWeb, Q-Pulse)Perform and document Corrective and Preventive Actions including closure review and approvalCreate and approve Engineering Change NoticesEnsure completeness and accuracy of Training Records to support all Quality related activitiesProvide QC support for R&D and Manufacturing Engineering initiativesDocument Field Actions and Quarantine reconciliationAssist in Complaint investigations and root-cause analysisFacilitate and serve as Subject Matter Expert for External AuditsGenerate and present Metrics used to demonstrate compliance with upper management including Quality and Management Reviews Show less

  • Senior Microbiologist / Manager

    Jun 2012 - Dec 2014

  • Manager, Quality Operations

    Oct 2005 - Jul 2012

  • Asst. QA Manager

    Dec 2006 - Mar 2008

  • Compliance Specialist

    Oct 2005 - Dec 2006
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  AllConnected

  Aug 2021 - now

  Maintain the cybersecurity posture of AllConnected and our client organizations.Mentor junior level cybersecurity analyst.Identify and mitigate potential risks. Configure security systems, analyze security requirements, and recommend improvements.Create network policies and authorization roles and defend against unauthorized access, modifications and destruction.

  • Sr. Cybersecurity Analyst

    Aug 2023 - now

  • Cybersecurity Analyst

    Aug 2021 - Aug 2023