Dynamic professional with proven record in ensuring quality and continuous improvements within the biotechnology, medical device and pharmaceutical industries. Carries results-driven experience in GXP/ cGMP/ ISO 9000 and 13485 procedures that maintain robust, compliant and consistent Quality systems. Develops and successfully implements training programs and departmental procedures. Possesses extensive knowledge of the Complaint Handling discipline; presented at the Advanstar/ CBI West Coast Product Complaints for Life Sciences Conference.

Supervisor, Quality- Product Complaints @ Oversaw and coordinated the day-to-day tasks of Quality Analysts, ensuring timelines and goals were met. Identified, reviewed and followed up on investigation related deviations, observations, findings, and corrective actions. Promoted a sustainable complaint-investigation program by ensuring that appropriate cGMP documentation of complaint investigations were generated, maintained and approved. Prepared and reviewed SOP's through the electronic document management system (EDMS). Identified inefficiencies in all departmental processes in order to develop changes in policies and establish new procedures. Led weekly cross-functional forum discussions that gained alignment on complaint thresholds and complaint escalation involving other functional areas. Initiated complaint-related events (QSE's and CAPA's) as necessary. Facilitated complaint-handling transition activities as a result of company acquisitions. From 2012 to 2014 (2 years) San Diego, CASr. Analyst @ Handled investigations of returned product, visual and functional in nature, and paper based for complaints that had no returned product. Prepared complaint handling records, work instructions, SOP’s and other documentation. Served as Subject Matter Expert (SME) for customer complaints system, participating in validation activities and complaint database design. As an SME, was involved with the coordination and compliance with requests of regulatory authorities during audits. Team member in Lean Management projects and kaizens that continuously improved complaint-handling processes, earning a company Six Sigma yellow belt certification. From 2009 to 2012 (3 years) San Diego, CAQuality Analyst II @ Triaged, investigated and performed data entry of product complaints for clinical and commercial products for US and global markets. Interacted with internal and external global cross-functional groups and CMO's to ensure complaint issues were assigned appropriately and investigated in a timely manner per Quality agreements. Developed training programs to train personnel, internally and externally, on product and process handling. From 2006 to 2009 (3 years) San Diego, CAQuality Control Supervisor @ Supervised team of five QC Inspectors in the QC of in-vitro diagnostic devices (IVDD) and reviewed all in-process and final QC release inspection testing data in all stages- incoming material inspections, stability data retain inspections and final packaging and labeling. Specialized in the QC of medical devices through the American National Standard- American Society for Quality Sampling Procedure and Tables (ANSI/ASQC Standards) sampling plans. Performed trend analyses of products, raw material usage and non-conformances to ensure that QC sampling techniques and methods were adequate and effectively working. Executed quick decision making to provide guidance and solutions to QC staff and Production personnel when conflicts arose. From 2005 to 2006 (1 year) San Diego, CAProduction Manager @ Oversaw team of 10 lab personnel in fulfilling customer orders for DNA/RNA synthesis products, HPLC and PAGE purifications, post-synthesis conjugation of oligonucleotides and final QC of product. Researched and performed supplier evaluations to ensure reasonable cost and quality of material used. Established key relationships as a CMO. Troubleshot customer questions or problems by extensive investigation of orders and suggested other possible options to guarantee best quality of product. Maintained Inventory and Product and Revenue Tracking for audits and monthly reports to Senior Management. From 2004 to 2005 (1 year) San Diego, CAAsst. Production Manager @ Assisted the Production Manager in supervising team of 15 lab personnel. Ensured proper staffing of all areas, personally filling in as needed to avoid disruption of lab process flow and final output. Performed DNA/RNA synthesis, HPLC, PAGE and final QC routines of oligonucleotides. Assured all products and documentation met release criteria before shipping. Aided in final packaging, labeling and shipping. From 2001 to 2004 (3 years) San Diego, CAProduction Associate @ Performed final QC of oligonucleotides. Performed final packaging, labeling and shipping. Key contact for Original Equipment Manufacturer (OEM) Contract Account-participated in daily phone inquiries, emails and weekly conference calls regarding status of in house orders. Participated in extensive product tracking and accountability in order to meet deadlines. From 2000 to 2001 (1 year) San Diego, CA

BS, Animal Physiology & Neuroscience @ University of California, San Diego Glenda Castro is skilled in: CAPA, GMP, Change Control, Validation, FDA, GLP, Biotechnology, Pharmaceutical Industry, Sop, Quality System, V&V, Technology Transfer, HPLC, ISO 13485, Medical Devices, IVDD, Product Complaints, ISO 9000, Complaint Investigations, Quality Assurance, Employee Training, cGMP practices, Product Launch, CMO management, Document Review, SOP Development, Risk Management, Root Cause Analysis, Complaint Management, Cross-functional Team..., Project Management, Batch Release, Quality Control, SOP Authoring, Lean Management, Training & Development, Document Management, Process Improvement, Policies & Procedures..., Deviations, Oligonucleotides, Shipping & Receiving, Records Management, Laboratory Skills, Internal Audit, Regulations, Organization Skills, Communication, Vendor Relations, Life Sciences