Olga Alvarado

***** ***** **. ***.* El Cajon CA. 92021 Cell: 619-***-**** Email: ad1jky@r.postjobfree.com Objective QC Analyst 1

Relevant Skills

Leaning Manufacturing Microsoft Word / Excel Machine Operator

ISO (5, 7,8)

Gown Qualifications

Packaging / Label View/Dataflex Light Power Tools

Kanban / Kaizen Line Clearance, GMP/SOP/ Batch Record

Manual Assembly

Bilingual -English/ Spanish Organizing Material Handler Education

Studies : Time Management Course San Diego, CA. 2006 Cuyamaca College El Cajon,CA. 1996 to 1998

Grossmont High School La Mesa, CA.1992

Bioserv in San Diego, CA 2021 to 2023

QC Analyst 1

Performing sampling, testing, and documenting of all potable and purified water as well as environmental monitoring samples. Responsible and all in house testing for water (e.g., Conductivity, Endotoxin, TOC, Bioburden), perform Environmental Monitoring of the Cleanrooms, Incubate and Innumerate touch plates from Environmental monitoring and manufacturing as well as other cGMP processes. Sample to be sent to outside lab for genetic ID. Was in charge of gown qualification for all personnel and ISO (5, 7, 8). May act as process owner for charge controls of SOPs, specifications, and Forms related to QC activities, assist with investigations for CAPAs, NCMRs, Complaints, and Deviations that are related to Quality Control issues, reviewing cleanroom EM investigations, reviewing, trending, and investigation excursions of the purified water monitoring data. Assist with special projects, internal investigations and internal audits as needed, preparation for FDA and other regulatory agency audits, inspections, and customer audits. Provide any assistance needed during these audits as needed. Enter data repost, give guidance, support all other departments on data integrity and Good Documentation/ Manufacturing Practices.

Bioserv in San Diego, CA 02/05/2019 to 2021

Manufacturing Technician

Performing in environment monitoring and competing documents. Cleaning and Sterilising glassware and other material. Stages material and equipment prior to manufacturing activities. Assist in formulation of product and ensuring Company’s goal. Operate aseptic filtration, filling, and crimping of product.Identify discrepancies during manufacturing activities and notify management and QA to ensure action is taken in a timely manner to prevent deviations and non-conformance due to incorrect documentation. As well, visual inspection, sampling, and packaging of the finished product. Working with particle counters, air samplers, touch plates, settling plates, and pharmaceutical products. Assisted in reviewing batch records. Knowledgeable in autoclave, dry heat oven, and other equipment. Assisted and other tasks assigned by the manager. SenDX Medical Inc in Carlsbad, CA 8/30/2017 to 8/30/2018 Manufacturing Technician

Work with supervisor effective training lower level and new associates and ensure safety and quality standards . Help built medical devices and products by using variety specialized equipments,fixtures,work instructions and test equipment .Follow documentation and policies and procedures as designated by company’s Quality System,assist in product processing and testing.Use basic problem solving skills to ensure stable operation of work cell, Report any problems and concerns with quality,processes,equipment, materials to Production Supervisor. Follow GMP,FDA,ISO regulations.Work with RD departement new products and procedures on Router,worked cleanroom,work area contain adhesives,solvent and chemical processes,Sustain lean manufacturing and 5S activities.Maintains a clean and organized work area to facilitate manufacturing functions. Grossmont Union High School District 3/2015 to 8/28/2017 Food Handler/Food Service Assistant

Arrange food and beverage item (eg. placing in steam tables, displaying, filling racks,etc). Clean utensils, equipment, and storage, food preparation and serving areas for the purpose of maintaining sanitary conditions. Collects payments for food items (eg. cash, fee, reduced medical offset, etc ). Inspects food items and supplies for purpose of quantity, and complying with mandated health requirements, load carts, prepares daily items counts and associated reports and provides documentation for items served. Transport food items and equipment to various satellite school cafeterias and other off-campus locations stockfood, condiments and supplies. Alere San Diego Inc. 7-200*-**-****.

Worked in 1st shift production Lead responsible for following all GMPs, safety,manufacturing and quality system procedures,this will include but not limited compliance with approved documentation and QSR, line clearance

,ongoing FDA/ ISO complaints,cost-effective.Responsible for daily/weekly production schedules,training and for other technicians and operators,ensuring that MFG.processes are set -up and operating in accordance with established procedures,Assist supervisor running production floor,preparing disciplinary actions and documentation,preparing performance evaluations,involved validation of new products processes or equipment. Worked in Dry room under green light,around hazardous materials.Knowledge of federal and other regulations 13485,CMDR.Worked with semi-automated equipment.Review MRP documentation and auditing operators Adherence to established procedures.Responsible for exhibiting professional behavior with both internal/ External business associates that reflect positively on company. Experience

Applied Biotech Inc. San Diego, CA. 11-2005 to 12-2006. Production Supervisor

Worked on 2nd shift production department team of 90 people, under FDA, cGMP regulated work environment, helped assemble medical devices including Flu, Strep A, Pregnancy tests, Drugs of Abuse for worldwide distribution. Responsibilities included, Supervise hands on all 2nd personnel follow production procedures per PMF and SOP instructions. Assisted Production Manager train production employees and machine operators learn assembly, pouching, kitting and material handling procedures. Delegated responsibilities to Production Leads and follow through assigned tasks to make sure production expectations are met. Worked closely with On Line QC inspectors meeting or exceeding quality expectations. Worked closely with all support teams including Warehouse, Planning, QC Labs and Document control. Responsible for providing expiration dates and lot numbers to assigned jobs for the production assembly process. Filled out, reviewed and signed off Line Clearance, Variance attachments and PMF's per completed lot/job. Submitted Final product samples to QC Lab for Final testing release. Supported lean manufacturing and continuous process improvement agendas including 5s, One piece flow, Kanban, Kaizen events. Conducted quality, safety and production performance meetings as needed. Responsible for approving 2nd shift ADP/payroll. Communicate performance issues to the Production Manager including discipline, hiring, termination, and promotions. Generated and submitted daily production reports to management. Continuously, kept teamwork practices in place through the end of company operations before moving business to China. 100% supportive, proactive and hands on supervision. Applied Biotech Inc San Diego, CA. 6-2005 to 11-2005 On Line QC Inspector

Worked on 1st and 2nd shift production team of 25 to 50 people assemble, pouch and kit medical devices for worldwide distribution under FDA, cGMP guidelines. Responsibilities included verifying jobs scheduled matching with PMF's assigned to production personnel. Line Clearance, Variances and other document attachments included if necessary. Conducted and documented hourly inspections at assembly, pouching and kitting process per SOP guidelines. Communicate to Production Leads and Supervisor on quality or work in process issues for immediate resolution. Continuously met or exceeded job expectations. Kept rework issues below allowed ratios. Promoted and transferred to 2nd shift as Production Supervisor. Manpower / Applied Biotech Inc. San Diego, CA. 7-2004 to 2005 Assembly Line Operator

Worked on a team of 25 people under FDA regulated work environment to help assemble medical devices for Flu, Strep A, Pregnancy and Drug Screen tests for worldwide distribution. Followed assembly of medical device process per PMF and SOP instructions. Participated in continuous improvement programs, including 5s, Kaizen events. Met or exceeded department expectations consistently. Assisted Team Leads set up jobs on assigned workstation as a material handler. Communicated to Production Leads of any material shortages issues. Promoted as On Line QC Inspector.

Cajon Valley Union School El Cajon, CA. 1995 to 2004 Teacher Assistant / Supervisor

Assisted 1st grade teacher on all school and classroom activities. Including materials used for daily programs / activities. Actively teaching group reading and math exercises. Responsible for classroom and playground safety. Kept close communication with the group and Supervisor on daily activities. Work schedule reduced due to State/ School budget limitations.

Personal Strengths Flexible/open minded Detail and Budget oriented Responsible

Positive and supportive Dependable Work well with others

Work well under pressure Ambitious Confident