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    Justina Moore

    Senior Computer Systems Validation Consultant, Advent Engineering

    Professional Background

    Justina Moore is a dedicated professional with approximately 20 years of experience in the GxP (Good Practice) industry, specializing in quality assurance and validation roles. Her diverse career has equipped her with extensive expertise in managing and developing quality systems across multiple high-stakes environments. Justina has successfully undertaken various technical roles, including Lead Validation Engineer, showcasing her ability to adapt and lead in dynamic settings. Additionally, her decade-long experience as a Quality Manager has enabled her to ensure compliance with regulatory requirements and industry standards effectively.

    Justina's career highlights include significant positions within renowned organizations such as AstraZeneca, Medimmune, and Leidos. At AstraZeneca, she was a vital contributor to the global data integrity program, collaborating with top experts from the FDA and MHRA to strengthen data management practices. Her role involved optimizing platform qualification and application validation strategies, demonstrating her commitment to advancing compliance initiatives and ensuring the integrity of data across enterprise-level applications. Justina also worked closely with a key founder of the Good Automated Manufacturing Practice (GAMP) guidelines, showcasing her involvement in shaping industry standards and regulations.

    Her experience extends across various facilities, including phase II clinical manufacturing plants, commercial manufacturing plants, and BL3 laboratories, underpinning a holistic understanding of the life sciences sector. Justina has a proven track record of transforming quality systems, aligning them with organizational goals, and fostering a culture centered around regulatory excellence.

    Education and Achievements

    Justina Moore's foundational education began at Miami Trace High School, where her interest in the sciences flourished. She went on to pursue higher education at Sinclair Community College before completing her Bachelor of Science degree in Biochemistry and Microbiology at North Carolina State University. This academic background has provided her with a robust understanding of scientific principles and laboratory practices, further enhancing her capabilities in quality assurance and validation.

    Throughout her career, Justina has developed an impressive portfolio of roles that reflect her diverse skill set. As a former IT Quality Manager in Clinical Development at Integrity Consulting, she ensured adherence to quality standards, bridging the gap between IT solutions and pharmaceutical development. Her work as a Validation Scientist I at Medimmune underscored her technical proficiency, validating systems critical to pharmaceutical manufacturing processes.

    Justina also showcased her analytical skills while working as a Lead Engineer at Leidos, where she held an Active Public Trust and Level 5B Security Clearance. Her early career as a Researcher in Product Research and Development for Procter & Gamble and as a Senior Researcher at Battelle allowed her to gain firsthand experience in the research landscape, contributing to her well-rounded expertise in both quality assurance and product development.

    Achievements

    Justina’s career is marked by several notable achievements that have positioned her as a leader in the GxP industry. Not only does she contribute to the integrity of highly regulated environments, but she also continuously advocates for enhanced validation strategies that align with technological advancements. Her collaboration with industry authorities has significantly influenced how organizations like AstraZeneca approach data integrity and quality systems.

    In addition to her technical roles, Justina has made her mark as a contributor to industry discussions on platforms such as the LinkedIn Forum, where she shares insights on quality assurance practices and validation in the pharmaceutical sector. Her commitment to community engagement within the field of biochemistry and microbiology further amplifies her influence and passion for the industry.

    With a career built on a strong foundation of education and a rich tapestry of professional experiences, Justina Moore exemplifies dedication and expertise in the GxP industry. Her journey reflects a commitment to continuous improvement, regulatory excellence, and the advancement of quality systems that assure the efficacy and safety of products in the life sciences sector.

    Related Questions

    How did Justina Moore develop her expertise in GxP industry practices over the past 20 years?
    What specific strategies did Justina implement to optimize validation processes at AstraZeneca?
    How has Justina's background in biochemistry and microbiology influenced her approach to quality assurance in the pharmaceutical sector?
    In what ways has Justina contributed to the development of GAMP guidelines throughout her career?
    What were some of the key challenges Justina faced in her role as IT Quality Manager at Integrity Consulting, and how did she overcome them?
    How does Justina stay updated with the evolving regulations in the pharmaceutical industry, especially concerning data integrity?
    What collaborative efforts has Justina participated in with former FDA and MHRA experts during her time at AstraZeneca?
    How does Justina’s varied experience across different facilities enhance her capabilities as a quality manager?
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    Location

    Raleigh, North Carolina