Daniel Carter Email & Phone Number

Tustin California

San Diego

Responsibilities:• APQR Reports: Author and Project Manager - manage internal data contributors, collate data - manage external (CMO) data contributors, organize review of external APQR reports - compile the report, route for review, revise per comment, coordinate report approval - used MS Project and milestone tracker to ensure task completion, communicate status• Project Management Support, Analytical Method Technology Transfer - established transfer timelines on MS project, tracked tasks until completion of transfer - maintained project tracker PowerPoint file to communicate status, risk areas to organization • Quality Reviewer of Deviation, Investigation, CAPA Records• Organize and Prepare Management Review Meetings - helped establish a scorecard to assess performance of functional areas to the GMP - worked with area managers to ensure their respective reports were completed on time - prepared the Management Review slides and organized the scorecardAchievements:• Consistently completed APQR Reports on schedule• Maintained productive relationships with CMO APQR Providers• Helped to create and implement a new Management Review Program/SOP• Helped implement a new Quality Risk Management System• Established a new SOP for managing product temperature excursions• Helped to create and implement a new Health Hazard Evaluation System

San Diego

Responsibilities:• Lead projects assigned by Quality Director, and work with the organization to drive projects to timely completion. Achievements:• Reviewed critical Quality files and verified completeness or corrected. • Established a paper based back-up system for processing records. • Improved sampling plan processes and procedures.

San Clemente

Responsibilities• Maintain the CAPA database, and represent the CAPA system in audits.• Project manager for high profile CAPA projects (e.g. assay improvement).Achievements:• Established a new CAPA system • Created and maintained a CAPA database for at-a-glance status report of open CAPA projects and a history of closed projects.

San Clemente

Responsibilites • Manged assay development projects: Establish project schedule (MS Project)• Assure design control by verification against a proceduralized checklist.• Schedule, chair and distribute minutes for project and design review meeting;• Compile the design history file.Achievements:• Established a project management process for assay development, transfer and launch• Improved cross functional cooperation and cycle times. • Project Manager for 11 new assay product releases • Recognized as “Outstanding Employee” for supporting new product launches. • Created a project office to enable effective tracking of multiple projects

San Juan Capistrano

Responsibilities:• QC testing and release of conforming product to the production schedule• Notification to the Material Review Board for non-conforming product• Scheduled laboratory testing and reporting to support production schedule• Performed QC testing to established test methods and specificationsAchievements:• Chaired Material Review Board for review and disposition of non-confirming product• Participated in Customer Review Board – supported product improvements, spec review• Designed and implemented a bioburden test program

Tarzana

Responsibilities:• Laboratory Technician, Immunology Department• Prepare laboratory tests (Immunoflourescence [IFA] slides, T and B cell typing

Bachelor Of Science (B.S.), Biology, General

Bachelor Of Science (Bs), Biology

Activities and Societies: Rugby Club