Kristen Howard

• Led data management activities across studies, ensuring data integrity, consistency, and protocol compliance.
• Enhanced data accuracy by implementing robust data validation and quality control processes.
• Managed vendor relationships to ensure timely delivery of high-quality products and services at competitive prices.
• Designed edit checks and validation rules within EDC systems to improve data quality and query resolution.
• Oversaw query generation, tracking, and closure to support accurate, timely database cleaning.
• Coordinated cross-functional data review with clinical operations, biostatistics, and programming teams.

• Directed product compliance reviews to align juvenile products with regulatory and customer requirements.
• Coordinated testing documentation, certifications, and technical files for finished goods and components.
• Reviewed supplier declarations and specifications to verify material and labeling compliance.
• Interpreted safety regulations and translated requirements into actionable internal procedures.
• Implemented robust record-keeping systems that ensured accurate documentation was maintained according to regulatory requirements at all times.
• Make data-driven decision-making and strategic insights using Six sigma and Agile methodologies.

·

• Subject Matter Expert of the Quality Assurance Technical Product Complaints Compliance, Data Analytics, and Documentation team at Biogen.
• Conduct commercial and clinical product complaint investigations and authored technically complex investigation reports.
• Collaborated with global patient safety, supply chain/trade and distribution, medical information, guidance and patient support, quality assurance, contract manufacturing organizations, and external call centers to enhance cross-functional communication and address product complaints.
• Collaboration with Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations and external Call Centers.
• Performed process monitoring to evaluate product quality ensuring Product compliance.
• Informed suppliers about necessary updates to maintain compliance., Managed the change control process to ensure product quality standards., and Managed CAPA processes to address and prevent quality non-conformities..
• CMO (Contract Manufacturing Organization) and third party manufacturing support.
• Monitored processes to evaluate product quality, ensuring compliance with regulatory standards and improving overall product integrity.
• Define and present functional and technical requirements to both business and IT stakeholders using Six Sigma and Agile Methodologies.

• Experienced in Product Complaint Receipt including handling of sample return and coordinating investigations with CMOs via Trackwise and Salesforce.
• Facilitated PC trending process, computed metrics, and authored quarterly reports to support data-driven decision making.
• Internal and FDA Regulatory audit experience, ensuring compliance in FDA 21CFR 820 and ISO 13485 and writing Annual Product Reviews per product.
• Conducted internal and FDA regulatory audits to ensure compliance with FDA 21CFR 820 and ISO 13485; wrote Annual Product Reviews for each product.
• Trained Patient Services staff and new hires to enhance onboarding and service delivery.

• Conducted product complaint investigations (deviation review/capa) utilizing Trackwise and Salesforce systems, enhancing safety by triaging adverse event cases.
• Training SME both created and conducted training sessions.
• Performed internal and FDA regulatory audits, ensuring adherence to FDA 21CFR 820 and ISO 13485 standards.

• Conducted Product Complaint handling in Trackwise and Salesforce databases and triaged safety Adverse event cases.
• Internal and FDA Regulatory audit experience. ensuring compliance in FDA 21CFR 820 and ISO 13485.
• Applied critical thinking to analyze problems, assess solutions, and make informed decisions.

• Facilitated data analysis to enhance clinical trial outcomes.
• Utilized Microsoft software to track data and present results effectively.
• Coordinated complex patient and provider schedules using electronic medical records and referral workflows.
• Monitored case details to ensure accurate documentation, timely follow-up, and compliance with care standards.
• Supported multidisciplinary teams by preparing records, correspondence, and clinical materials for daily operations.

• Performed STAT lab blood gas analysis and osmolality
• Ensured sterility in laboratory settings to maintain sample integrity.
• Conducted urinalysis and microscopic examinations to analyze patient samples.
• Urinalysis and microscopic technique
• Maintained laboratory supplies inventory and verified viability of supplies before use.
• Analyzed laboratory findings to ensure accuracy of test results and support patient care.
• Participated in evaluation of new laboratory techniques, products and instruments.
• Enforced quality control protocols to uphold testing accuracy and reliability.
• Medical Laboratory Technician specimen processor