Jade Reagan

Experience

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  Programming for Biologists

  Aug 2014 - Aug 2018

  Project Analyst

  • Analyzed the long-strand sequencing abilities of the Oxford Nanopore MinION Sequencer• Evaluated the accuracy of genome• Utilized programming techniques: alignment, assembly, and polishing of data• Produced sequenced DNA /FAST5 file and separate BLASTn database for genomes• Evaluated data using applied biological programming in Python and R

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  Hitech Pharmaceuticals

  Sept 2018 - Dec 2020

  Regulatory Compliance Manager (Microbiology)

  • Implemented, developed, and reviewed Standard Operating Procedures (SOPs)• Ensured standards and analytical procedures followed USP, cGMP, and FDA regulations and prepared the department for audits (21 CFR, ISO 13485)• Instated new media and testing procedures to optimize budget and workflow for the detection of bacteria, yeast, and mold• Certified instrument performance and arranged for equipment replacement, service, and repair• Created microbiological testing summaries, sent reports, and invoiced clients• Managed departmental budgets and analyzed cost efficiencies• Performed proficiency surveys, reviewed quality control, and adjusted policy and procedures• Maintained inventory by checking stock, anticipating needs, expediting orders, filing warranty claims, and verifying receipts• Provided instruction to staff on proper use of lab equipment, lab safety, protocols, and procedures• Maintained laboratory staff by recruiting, selecting, scheduling, training, and overseeing employee tasks and time management Show less

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  Immucor, Inc.

  Jan 2021 - Feb 2022

  Biological Quality Assurance Specialist

  • Identified areas for improvement in relation to department SOPs, forms, attachments, work instructions, etc.• Served as Subject Matter Expert (SME) for nonconformities that were identified in relation to the department• Assisted in company-wide gowning and aseptic technique classes for gowning levels L through C• Conducted Out of Specification (OOS) Investigations for test results in Microbiology laboratory• Served as Point-of-Contact for the coordination of outsourced services including microbial identification and sterility testing• Collaborated on departmental aids including: on-the-job training (OJT) checklists and guidelines• Identified nonconformities in environmental monitoring data and utilized investigational tools to determine the root-cause• Played a key part in the execution and implementation of change control for validated processes including BacT Alert instrument software from Observa to MYLA and media transition• Identified deviations in data trends and maintained organization of large aggregates of data• Worked directly with shipping and MQA departments to anticipate and maintain laboratory supplies• Served as safety and evacuation warden for department and routinely identified safety concerns Show less

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  Centers for Disease Control and Prevention

  Feb 2023 - Sept 2023

  Quality Manager

  • Participated in the management review process to advise laboratory management, at the decision-making level for laboratory policy, objectives, and resources on the performance of the quality management system• Conducted periodic internal and external quality audits to include assessment of laboratory data; documenting regulatory compliance and identifying/reporting deficiencies• Ensured laboratory quality management requirements for standard operating procedures (SOPs) and protocols are instated and meet appropriate regulatory requirements• Preformed spot-checks to verify enumerators have implemented new policies and are competent in new processes• Preformed gap analysis to ensure current QMS meet ISO and CLIA standards• Monitored laboratory equipment and assisted with routine maintenance, qualification, and calibration• Investigated the cause of Non-Conformances• Determined Corrective Actions to mitigate any impacts or future risks Show less

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  DelRicht Research

  Sept 2023 - Apr 2024

  Sr. Clinical Quality Assurance Coordinator