Sandra Forrer Email & Phone Number

Bothell, Washington, United States

The Quality Assurance Associate II is responsible for supporting the NanoString Quality Management System (QMS) process. This position’s primary focus is providing overall Complaint handling support within the company in order to ensure that customer complaints are properly assessed, tracked, trended and documented. This position’s secondary focus is.

San Jose, California, United States

Guiding the RA/QA component in the development of a novel endotracheal tube and 510K submission. Additionally setting up the initial quality systems for regulatory compliance with 21CFR part 820 and ISO 13485. Responsible for Post Market Surveillance reporting and regulatory release in foreign markets.

Remote

• Executed duties as Quality contact and primary Genomics Subject Matter Expert for Compliance activities including monitoring and reporting on KPI, nonconformances (NCR), and CAPA. NCR and CAPA timelines have been met.
• Improved average turnaround time to less than 20 days on changes to critical processes, instructions, facilities, equipment, and systems through the Change Control program by assessing the risk impact on validated.
• Ensured compliance as the Quality representative for the new Design Change Projects task force. Identified and implemented improvement opportunities for established Quality systems, processes, and procedures.
• Provided training to support improvements to CAPA, NCR, Change Control, Facilities, and Risk Management across multiple sites.
• Delivered risk and quality reviews for annual supplier evaluation with the procurement and manufacturing teams. Identified critical suppliers and reduced inactive suppliers by 25%. Served as the Quality representative.
• Reviewed and approved protocols and reports for enhanced validation programs of existing equipment, manufacturing qualification, computer systems, and process validation.

Santa Clara

Project Manager for QSR requirements. Monitoring quality systems as they migrate from ISO 13485 to include 21CFR820. Assisting Manufacturing and Quality Assurance to insure compliance with both regulations.

San Jose, California, United States

• Group Exercise leader certified in SharQui, RAQ the Barre and Pound fit. Primary focus is bellydance based fitness. SharQuí teaches you authentic bellydance moves in a cardio workout that’s as fun as it is good for.
• belly dance technique training method. Experience essential belly dance fundamentals seamlessly merged into a fierce full body barre workout! Our barre fitness program bridges the best in exercise safety & science with.

Santa Clara, CA

Quantumcyte Inc is a start up focused on cancer treatment diagnostics. I wrote the QMS documents and working on proof of concept studies utilizing tissue samples and novel polymer chemistry.

Mountain View, CA

Develop immunochemical and cell-based assays for measurement of potential pharmacodynamics markers in biological matrices such as whole blood, serum and plasma. Conduct bio-analytical sample analysis in support of Non-GLP and GLP pharmacology and toxicology in vivo studies. Prepared Standard Operating Procedure, validation protocols and reports.

Santa Clara, CA

Organized, planned, implemented, and maintained all EIA/rPCR manufacturing methods and processes for new and existing products. Managed, motivated and guided 10 direct reports in achieving and exceeding departmental and corporate goals and deadlines. Production was never on back order in part due to energetic teamwork.- Provided the necessary support and.

Fremont

Oversaw the daily lab management of a biomarker discovery and assay support group for several research targets including cardiovascular disease, metabolic disease and novel chemistry for inflammation. Routinely performed multi-assay analysis on samples from large clinical and preclinical studies eliminating the need for external analysis costs.- Constantly.

Developed and executed multiple target screening assays for lead structure drug discovery projects. Maintained database for raw and processed data as part of the compound lead discovery process in a cytokine inhibition project. - Developed robotic methodologies for screening 96 and 384 well small molecule libraries against selected inflammation and.

Palo Alto, California, United States

Plant biochemist in the development of environmentally friendly herbicides.

Medical Device Certification, Medical Device Regulation, 3.94

Medical Devices Certificate Program Medical devices include a broad array of products, from the simple tongue depressor to surgically.

Bachelor Of Science - Bs, Biochemistry

Activities and Societies: Biology Seminar Group

Bachelor Of Science (Bs), Biology/Biological Sciences, General

Bachelors in Biology