Pamela De Loa Email & Phone Number

Hillsboro

Senior Quality Assurance Specialist part of a dedicated cross-functional team working on production start-up activities for new individualized cell and gene technologies.

Hillsboro, Or

-Provide Quality oversight for daily Aseptic Operations shop floor activities. -Complex discrepancy assessment, management and closure.-Perform batch record review, AQLs and issue shop packets. -Presenter for batch records and support facility tours during audits and regulatory inspections. -Work closely with Manufacturing personnel to ensure operational adherence to GMPs and help maintain a state of inspection readiness. -Assist with managing quality risks in the Quality and Compliance System.

Hillsboro

Job Duties/Responsibilities Include:-Develop and execute Health Authority inspection and audit preparation plans, manage the readiness activities-Manage and facilitate internal audits/assessments, partner audits and regulatory inspections for the site-Lead Auditor and Co-Auditor in Site Self Inspections at Genentech Hillsboro Operations-Participate as a Co-Auditor at other Roche and Genentech sites-Manage compliance risks and track remediation activities/action plans to closure-Support creation and maintenance of documents supporting Regulatory filings-Compliance representative on cross-functional and multi-site teams-Interact with senior internal and external personnel on significant matters-Represent organization as a prime contact on initiatives and projects

Aloha, Oregon

San Francisco Bay Area

Responsible for inspecting and testing incoming raw materials for the manufacturing of blood glucose tests strips. Also perform final product testing and release of blood glucose test strips.

Hayward, Ca

Responsible for supporting engineering and process improvement projects. Assisted with closing Change Requests and Corrective and Preventative Actions. Supported product investigations and customer complaints. Collected, analyzed and trended data from cGMP and R&D equipment. Created and revised Standard Operating Procedures. Supported R&D and training activities.

Hayward, Ca

Responsible for operation, trouble shooting and minor repairs of the Form Fill Seal machine. Assisted Engineers with red lining and writing Standard Operating Procedures. Prepared, autoclaved and set up equipment. Performed docmuent review and general housekeeping.

South San Francisco, Ca

Assisted with all start up activities of a new manufacturing facility and equipment. Duties included: coordinating daily and weekly activities, writing and developing Standard Operating Procedures and Batch Records, assisting with validation protocols, equipment trouble shooting, developing cGMP procedures, ordering supplies, training and general housekeeping.

South San Francisco, Ca

Responsible for aspetic processing of pharmaceutical components. Maintained documentation of batch histories, helped QA resolve outstanding issues and assisted with planning daily activities.

San Francisco, Ca

Responsible for all daily activities of The Sports Medicine Shop, a retail store which specialized in orthopedic braces and other types of medical supplies. Daily activities included purchasing, inventory management, medical billing, assisting doctors and patients to find appropriate orthopedic devices and patient education. Developed a full-scale catalogue of all available products and increased store capacity by twenty-three percent.

Master Of Science - Ms

Masters, Education

Activities and Societies: Graduate Assistant Athletic TrainerSpent one semester student teaching sixth and ninth grade biology in the New.

Bs, Athletic Training

Activities and Societies: Worked and travelled as a student athletic trainer for a variety of men and women's athletic teams.

Bachelor Of Science - Bs, Athletic Training