Clinical Research Quality

LAWANDA M PAGE, MBA

Elgin, SC

803-***-**** *******.******@*****.***

www.linkedin.com/in/lawandamiller

CLINICAL RESEARCH STUDIES TEAM LEADERSHIP & TRAINING QUALITY ASSURANCE Dynamic, results-oriented, Clinical Research Professional highly regarded for supporting the development of clinical reports and studies to create high-quality products that meet both business objectives and regulatory standards. Compiles and analyzes data to evaluate product safety and performance, recommending solutions to improve outcomes. Strong background in project and performance management, with a proven track record of training cross-functional teams and guiding them to produce deliverables on time, within budget, and exceeding expectations. Leverages outstanding communication skills to build trusting relationships with colleagues, vendors, and key stakeholders. Out-of-the-box thinker who introduces continuous process improvements to ensure successful clinical trials. Highly organized, with a keen eye for detail and the ability to prioritize and manage multiple projects simultaneously. Thrives in fast-paced and diverse environments that champion innovation and collaboration. SELECTED HIGHLIGHTS

Exemplified good clinical practices and regulatory standards throughout professional and academic experience, continually expanding understanding with the pursuit of a Master of Science (Candidate) in Applied Clinical Research from St. Cloud State University and excelling in a competitive internship at the Carolinas Research Center under Benjamin Adetunji, MD.

Fostered collaboration with cross-functional teams and provided real-time support and guidance to analytical laboratory activities, production lines, and pharmaceutical development operations as a Batch Record Reviewer with Nephron Pharmaceuticals, analyzing completed drug product test results, raw data, and laboratory notebooks, thoroughly investigating any unexplained deviations, and recommending solutions to promptly drive resolution.

Upheld rigorous standards as the Regulatory & Compliance Specialist at Community Medical Clinic, Kershaw County by completing careful reviews of publications, seminars, and communication briefs to track and update national and international registration requirements and leading the daily activities of two regulatory team members.

Ensured timely execution of two multi-center operational and process improvement projects that were conducted by primary healthcare providers at CMCCKC, overseeing daily operations and communicating progress, protocol guidelines, and regulatory compliance mandates to clinical staff, stakeholders, and board members.

Performed a variety of supervisory duties as a Technical Supervisor/Consultant for Midlands Neurology & Pain Associates, PA, including planning, assigning, and directing work, while also managing and verifying that the lab’s performance testing program was related to services offered and facilitating training and ongoing development initiatives to educate two employees. CORE COMPETENCIES

Clinical Research Studies Data Analysis & Reporting Relationship Building

GCP/GDP/cGMP Compliance Pharmaceutical Development Project Management

Quality Assurance Management Process Improvements Vendor & Supplier Management

Training & Performance Management

Continuous Quality Improvement

Budget Management

Batch Release

Root Cause Analysis

Strategic Planning

EDUCATION

St. Cloud State University, St. Cloud, MN: 2021

Master of Science (Candidate) – Applied Clinical Research South University, Columbia, SC: 2012

Master of Business Administration – Healthcare Administration Morris College, Sumter, SC: 2000

Bachelor of Science – Biology

Internship:

Carolinas Research Center, Charlotte, NC; Site Manager – Benjamin Adetunji, MD – Pediatric Type II Diabetes, Ulcerative Colitis, & Asthma Lawanda M Page, Resume – Page 2-803-***-**** *******.******@*****.*** PROFESSIONAL EXPERIENCE

NEPHRON PHARMACEUTICALS WEST COLUMBIA, SC 2017 TO CURRENT Batch Record Reviewer

Review 20+ completed drug-product batch records per day for overall completeness and correctness in alignment with all current good manufacturing practice (cGMP) standards, thoroughly investigating any unexplained deviations and recommending solutions to promptly drive resolution. Ensure all deliverables and documents remain compliant with approved SOPs and regulatory and cGMP guidelines, as well as Environmental Health and Safety regulations, and all compendial, internal, and client/sponsor-specific requirements.

Diligently record laboratory testing activities and results, analyze and approve drug-product stability reports, and utilize knowledge of LabVantage Management System to release drug-product Raw Materials and validate all analytical reports and COAs.

Execute in-process QA audits to assess the validity and control the quality of the product, in addition to guaranteeing the compliant release of raw materials and components prior to the manufacturing and packaging processes.

Provide real-time support and guidance to analytical laboratory activities, production lines, and pharmaceutical development operations, introducing improvements to boost efficiency by 15%.

Analyze completed drug product test results, raw data, and laboratory notebooks to verify prepared Batch Records prior to each lot's final disposition.

Review the Certificate of Analysis, stability data, and laboratory worksheets for all finished product lots. COMMUNITY MEDICAL CLINIC, KERSHAW COUNTY CAMDEN, SC 2016 TO 2017 Regulatory & Compliance Specialist

Led the planning and execution of short and long-term regulatory submission initiatives, implementing strategies to achieve approvals 95% faster. Prepared and compiled files and reports for submission, preparing document packages and responses to inquiries in alignment with various Regulatory Bodies, including Food and Drug Administration, South Carolina Free Clinic Association, South Carolina Board of Nursing, and South Carolina Board of Pharmacy. Offered leadership and guidance while managing the daily activities of two regulatory team members, training them in equipment usage and clinical best practices, in addition to communicating all regulatory changes and updates. Evaluated audit findings to facilitate change with ongoing projects as needed.

Devised, scheduled, and directed a variety of activities and programs throughout the clinic site.

Negotiated with outside agencies to resolve critical regulatory issues and minimize future problems.

Meticulously prepared outlines, summaries, status reports, graphs, charts, tables, and slides for distribution to other departments.

Conducted careful reviews of publications, seminars, and communication briefs to track and update national and international registration requirements.

Gathered requirements, prepared $200,000 budgets, and monitored project and program costs, while also collecting data to display the quality, cost, service outcomes, and progress towards achieving goals.

Ensured that quality improvement and innovation work focused on the achievement of informed consent, patient-safety, clinical- staff vitality, and clinical protocol adherence.

Project Coordinator

Managed two multi-center operational and process improvement projects conducted by primary healthcare providers at CMCCKC, overseeing daily operations, and coordinating the activities of cross-functional teams to execute as per requirements. Quickly resolved and escalated issues to avoid schedule delays. Communicated progress, protocol guidelines, and regulatory compliance mandates to clinical staff, stakeholders, and board members.

Monitored monthly expenditures relative to $200,000 budgets, identified variances, and compiled findings in reports for key stakeholders.

Generated in-depth reviews of documentation to support monthly revenue recognition and invoicing.

Performed data analysis to prepare the budgetary forecast for all quarterly equipment, software, and disposable supply purchases, in addition to approving SAP and other large purchases.

Proofed and revised the Site and Core Informed Consent Forms for compliance with sponsor requirements, local regulatory requirements, and all Good Clinical Practice (GCP) guidelines. Lawanda M Page, Resume – Page 3-803-***-**** *******.******@*****.*** MIDLANDS NEUROLOGY & PAIN ASSOCIATES, PA COLUMBIA, SC 2014 TO 2015 Laboratory Operations Supervisor

Identified and resolved technical problems, ensuring that remedial actions were taken as soon as test systems deviated from the laboratory’s pain management protocol and established performance specifications to maintain seamless operations. Led employees to report patient urinalysis results to the neurologist and physician’s assistant. Monitored test systems for functionality, recommending improvements that drove efficiency by 85%.

Verified the completeness and processing of 300+ laboratory orders per week within the Electronic Health Record and via paper acquisitions for all collected specimens.

Facilitated training and ongoing development initiatives to educate 2 employees on the clinic’s urine collection and documentation process, the IMS electronic medical records system, and the CLC 720 Chemistry Analyzer operating system to improve department performance and productivity by 85%.

Performed a variety of supervisory duties, including planning, assigning, and directing work, while also managing and verifying that the lab’s performance testing program was related to services offered. CONSTANTIA BLYTHEWOOD, LLC BLYTHEWOOD, SC 2012 TO 2014 Quality Assurance Associate

Guaranteed that all processes were correctly conducted, troubleshooting quality assurance issues, and utilizing the CAPA process to eliminate non-conformities. Entered data and performed database management for the quality system, and prepared project and quality metrics reports based on production activities and quality research. Documented internal regulatory processes, ensuring all rules were communicated through QA policies, procedures, and SOPs. Presided over improvement programs to enhance overall quality by 80%. Delivered leadership and guidance in alignment with all global strategic objectives.

Led investigations into quality events, incidents, queries, and complaints, performing root cause analysis, and introducing corrective actions to resolve issues.

Maintained a detailed schedule of all quality legislation and compliance issues to easily measure process effectiveness.

Gathered materials for submission to such regulatory agencies as Safe Quality Foods and the National Science Foundation.

Scheduled and completed 30+ customer, vendor, facility, and system audits per year, quickly communicating any critical compliance risks to senior management.

CR BARD INC MONCKS CORNER, SC 2007 TO 2008

Complaint Coordinator

Handled all complaint activities while following approved procedures, continuing to monitor the investigation and follow up activities to ensure proper closure. Delivered complaint data and trend analysis within established timelines to senior management, and tracked corrective action in relation to complaints and report trends.

Collaborated with six QA and Process Engineers to complete complaint investigations in a timely manner to help facilitate complaint closure.

Reviewed and revised all complaint coding for data entry.

Participated in field actions, recalls, special projects, and other duties as assigned. ADDITIONAL CREDENTIALS

TECHNICAL SKILLS Microsoft Office (Word, Excel, PowerPoint, Outlook, Access, Publisher) / MODA-ES / LIMS System / TrackWise System / SAP / DBA Tracking System / IMS / Electronic Data Capture (e.g. Oracle Inform, Rave, Medidata)

VOLUNTEERISM Community Medical Clinic of Kershaw County, Camden, SC INTERESTS Watching movies (sci-fi, foreign films and documentaries) and reading fantasy novels

Contact this candidate