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.
• 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.
• 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.
• Consistently completed APQR Reports on schedule

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

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

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