Details are what drive me, and my orientation to detail has served me well in both my professional and personal lives, as it is who I am, not who I have learned to be. My passion for details also hones other core competencies in my skill set, such as my organizational and writing abilities. Additionally, this affinity for details is the source of my ability to give the things I work on that bit extra.I have 15 years’ expertise in regulatory compliance, quality assurance, and manufacturing/packaging operations within GMP environments and am a critical thinker with sharp root cause analysis skills. I'm a strong technical writer with demonstrated results authoring comprehensive, concise descriptions and eloquent arguments that support conclusions. I compose effective and clear technical documents of all types, including investigations, SOPs, and audit responses. I'm a highly organized, dependable, and an engaged member of the team.I also have a passion for learning and continuous improvement. I’m an agile and adept learner who quickly understands and applies new concepts to execute tasks right first time from the outset. As I continue to execute a task, I enjoy making both incremental and significant improvements to the process or end result. An example of this is when I taught myself the methodologies for adult learning and developed a comprehensive five-part course covering compliance with cGMP regulations. This program became source material for the Annual GMP Training at Johnson & Johnson Consumer, Inc. Lancaster for 2018, 2019 and 2020. When I had begun developing this training, I had no prior training development experience, but I was able to learn on the fly and skillfully meet a need at my organization. My core competencies & skills include:cGMP · Investigator · Consumer Complaint Program Lead · Regulatory Compliance · Inspection Management · Supplier Quality Management · Quality Metrics · Technical Writing · Annual Product Review (APR) · SOP Creation/Revision · Training · Auditing · Data Analysis · Consent DecreeSAP · EtQ · trü · Remetrex · Adobe Acrobat · Pas-X (MES) · Audit Tracking Management System Administrator · Microsoft Office with LinkedIn Badges (top user) for Word, Excel, Outlook, PowerPoint, Visio · Mentor for System Navigation/FunctionsOrganizational Skills · Written Communication · Leadership · Results-Driven · Critical Thinker · Quick Learner · Resourceful · Autodidactic · Creative Thank you for visiting my profile, and your interest!
