Stephanie Skipper Email & Phone Number

Lawrenceville, Ga, Us

Lawrenceville, Ga, Us

QUALITY MANAGEMENT SYSTEMS (19+Years)• Provides independent, objective advice to organizations on strategies to improve the effectiveness of quality management systems and their operational processes. • Develops manuals, plans, procedures, and processes. Performs assessments to guide and assist clients with implementing or remediating FDA -regulated Quality Management Systems, processes and operations or to become accredited by the International Organization for Standardization (ISO).• Performs regulatory functions that intersect Quality and Compliance requirements.• Performs quality assurance functions and activities at levels from task and process owner through chief quality officer.CLINICAL QUALITY ASSURANCE (6 Years)• Support the clinical project team with clinical study document development.• Assess clinical trial protocols investigator brochures, IRB documentation, case report forms, clinical study databases, trial master files and study data.• Risk-based planning and executing the study audit schedule.• Evaluate data transfer, data format specifications, data management systems and data management processes.Standards: FDA GCP Regulations and ICH standardsQUALITY AUDIT (19 Years: 284 audits performed)• GMP/820 retail certification auditor. • Provide independent third-party audit of quality management systems and operations.• Provide internal quality audits, mock FDA PAI and gap analysis audits. Standards: FDA 21CFR11, FDA 21CFR210/211, 21CFR820, FDA GCP Regulations and ICH standards, ISO 9001:2015, ISO 13485:2016COMPUTER SYSTEM & SOFTWARE VALIDATION (15 Years)• QMS software selection assistance• Develop and execute Validation Master Plan, Trace Matrix, Risk Assessment, IQ/OQ/PQ Test Scripts, Summary Report, SOPs, Error reports. • Primary experience with computer software used in medical devices and regulated quality management systems. Extensive data center validation for regulated customers.

Chelsea, Massachusetts, Us

April 2024 I came into a fast-paced start-up software company with operations ongoing and a need to preserve the forward progress of the organization as a whole and consequently, requiring that I be on task as a detailed oriented professional manager and leader capable of contributing to forward progress of ongoing quality initiatives under intense time constraints. The company was in a unique situation having multiple major audits all due between May and Sept 2024 and having lost its entire quality department staff. Determined not to let a single milestone slip its timelines, I prioritized the milestones, structured my priorities and addressed each challenge flawlessly.Within 180 days I successfully delivered the following list of major initiatives: 1. Successful customer qualification audits2. ISO 9001:2015 certification audit and report with no observations and no recommendations. 3. SOC 2 certification audit and report with no observations and no recommendations. 4. Quality Reviewer and Approver with Software Release Authorization for the company’s flagship software product.5. Maintained the Quality Management System and operations as a one-person organization. Assured completion of quality department activities necessary to pass ISO 9001:2015, SOC 2 and customer audits.6. Worked with the product development, engineering, and validation teams to implement artificial intelligence (AI) capabilities into the software product providing guidance on 21CFR11 compliance considerations, validation strategies, and gaining industry acceptance of AI in a QMS software product.Unfortunately, the internal constraints of a start-up could no longer support our continued engagement, although I would have liked to have continued on to see my new initiatives to develop a customer self-service audit portal and to further develop AI and QMS functionality into the Res_Q software platform to fruition. I am a pro consultant available for 1099 or W2 assignments.

Ms, Pharmaceutical Quality Assurance And Regulatory Affairs

Ba, English And Biology