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 supporting general QMS functions, such as internal and external audits, nonconformities and CAPA.Ensure consistent implementation, improvement and compliance to the NanoString Quality System and global regulatory requirements including, but not limited to; the FDA Quality System Regulation (QRS), Canadian Medical Device Regulatory (CMDR), ISO 13485, and In-Vitro Diagnostic Directive (IVDD).Individual is a team player working among different business units within the company to attain root cause of issues and to facilitate resolution. In addition, individual can also work independently as needed and is capable work well on fast-paced environment.

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 with less than 5% overdue for site OFS.• 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 systems.• 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 for the Material Review Board for noncomplying material and for Supplier Corrective Action Reports.• Reviewed and approved protocols and reports for enhanced validation programs of existing equipment, manufacturing qualification, computer systems, and process validation.• Facilitated Inspection Readiness and audit representation as the ISO 13485: 2016 and ISO 19011: 2018 Certified Lead Auditor (BSI). Completed Notified Body certification for SCS to MDSAP in 2018 and IVDR in 2023.

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 you. RAQ THE BARRE®, by RAQISA® is the nationally accredited barre fitness • 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 ancient movements! Match barre strength with oriental dance grace and improve your alignment, core strength, flexibility, and muscle balance! RAQ THE BARRE® is a fun, approachable method enjoyed by both dancers & fitness enthusiasts across the globe! Instead of listening to music, you become the music in this exhilarating full-body workout that combines cardio, conditioning, and strength training with yoga and pilates-inspired movements. Using Ripstix®, lightly weighted drumsticks engineered specifically for exercising, POUND transforms drumming into an incredibly effective way of working out.Designed for all fitness levels, POUND® provides the perfect atmosphere for letting loose, getting energized, toning up and rockin’ out! The workout is easily modifiable and the alternative vibe and welcoming philosophy appeals to men and women of all ages and abilities.

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 leadership to Specialty Products Reagent Chemistry and Rare Reagent departments resulting in a highly motivated, cross-trained team capable of efficiently supporting the highly changeable and adaptable nature of an entrepreneurial production unit.- Created and monitored production planning to insure accurate, on time product delivery of high quality product per the Master Schedule with minimal overage or scrap at or below cost targets. Worked with other operations personnel to develop a dependable MPS/MRP and supported indirect expenses supporting validation and improvement work.- Performed testing and formulation of reagents and reviewed batch records in compliance with Quality System Regulations. Worked with Quality Assurance to modify documents to reflect process improvements.- Supported continuous product and process improvements by working with the management team in defining improvement objectives and allocating the necessary resources.- Ensured the efficient use of resources, material, equipment and personnel in producing cost effective, high quality products.

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 expanded the biomarker assay portfolio to meet expanding therapeutic areas. Evaluated and optimized commercially available kits and novel protocols to meet diagnostic needs. - Prioritized and performed 40 assays on 5 different platforms for plasma, serum, urine, tissue lysates and cell culture media in 5 species.- Routinely received, organized and catalogued large numbers of samples from in-house and external researchers. Implemented standardized test requests, test sample requirements and data reporting formats resulting in fewer errors and faster turnaround time.

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 oncology targets. Over 300,000 compounds were screened using two screening platforms. Biochemical follow-up on putative hits led to the development of new chemistry scaffolds for synthesis.- Supervised intern in the development of new screening methods aimed at eliminating the use of radioactive materials, reducing radiation exposure levels and radioactive waste costs. New projects were developed using non-radioactive assays.- Analyzed data through the use of Activity Base, Spotfire, AIM and Pipeline Pilot programs. Data was made available to the Computational Chemists to perform Qualitative Structure Activity Relationship Analysis, which ultimately directed the project chemistry synthesis program.

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