Claudia Cabrera Email & Phone Number

Hercules

Provide leadership support for daily batch release operations, deviations and nonconformance management.Support Global Supply Chain operations across plants across the globe.Oversee and standardize quality system practices that support the manufacturing of diagnostic medical device and life science products across multiple Northern California sites.Collaborate with the Quality Systems Manager and Quality Engineering Manager to support initiatives in risk management, QMS harmonization, and training, QMS performance monitoring, and internal and external audits.Advise site-based teams with appropriate actions in response to identified product performance issues.Review and approval of technical design documentation such as requirements, risk analyses and validations.Evaluate and authorize product & process changes to ensure product conformity & regulatory requirements are met.Support a wide range of continuous and process improvement initiatives such as annual quality planning, process flow mapping, employee training and collaborative global quality objectives.Promote an understanding of quality-related requirements and risk-based approaches throughout the organization.

Hercules, Ca

Manage and support the CDG NorCal QMS Quality Notification end to end (Nonconformance/Deviations) process and related CAPA activities.Lead and Coordinate a functional team, focusing on daily Quality Notification open tasks during investigation, follow-up and related CAPA actions to support product release.Facilitate weekly Material Review Board (MRB) Meetings where data is presented and analyzed to determine material disposition, release and track and trending of issues. Collaborate and provide technical and analytical support to functional area Managers and help resolve identified product quality issues and ensure business needs are met.Support audits and inspections and other quality and compliance activities.Train cross-functional key stakeholders on various QMS processes (risk management, CAPA and non conformance investigations, root cause analysis.)

Vacaville, Ca

Quality Investigator, Sr. Quality Specialist* Prepared, reviewed and approved discrepancy records to ensure the appropriate level of rigor was applied to determine cause, impact, and corrective actions while adhering to cGMP Regulations and Standard Operating Procedures.*Designed, implemented, facilitated, and coordinated the Quality Review Board process in Vacaville. Streamlined the investigation data report, so senior cross-site leadership could make meaningful and timely decisions on releasing a high-quality product. The report ensured one set of numbers were utilized by all and eliminated duplicate work.

Bachelor Of Arts In Management, Business Administration, Management And Operations

Associate Of Arts And Sciences - Aas, Biology/Biological Sciences, General

Associate Of Science - As, Biology Technician/Biotechnology Laboratory Technician