Monique Muedano
Simi Valley,CA
Summary
I am a quality assurance professional with 10 years of experience within the biotech and pharmaceutical industries. My diverse background encompasses various aspects of manufacturing/distribution and quality assurance. I excel at developing work processes and work flows to enhance business performance and have a keen eye for detail. I am passionate about continuous growth as well as working in biopharmaceutical.
Overview
9
9
years of professional experience
Work History
Senior Quality Assurance Associate
Amgen
08.2020 - Current
- Participated in external and internal audits. (FDA, Korea, GQC).
- Set up tours (mock audits) for Inspection Readiness for B23
- Deliver quality and compliance oversight assessments and GEMBA walks to maintain inspection ready facility.
- Performs Quality review and approval of Trackwise Records for Minor Deviations Works with Manufacturing on real time Triages, Run Queries in Trackwise for major and minor deviations.
- Currently supporting Micro Transformation Project (MTP) for B7 RT Reports process improvements
- Cross functionally trained in Cell Culture and Purification in (BRR) Batch Record Review and providing floor support for both areas.
- Trainer the trainer certified , training of newly on boarding temps on (BRR) for the Downstream (Purification) area and Upstream Cell Culture (CCX)
- Led daily QA meetings to monitor disposition timelines.(BRR,Deviations,Document review).
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Performs Electronic Batch record review (BRR) of paper and electronic for product release For Purification and Cell Culture.
- Review and approved DS production documents (SOPs,MPs,EBRs)
- MES review take out logs in SFO's, Review Exceptions, Utilize intray, review CQA's. Cross -Check Assest numbers in Maximo, review PI Trends/Tags.
- Review and approved PVL/GMBR/PMBRs to support Electronic Batch Record (EBR).
- Provide quality oversight for manufacturing and support floor operations for clinical and commercial.
- Perform Changeovers for DSI and DS & Cell Bank areas.
- Performs Review of RT Reports.
- Reviews/Locked (MICs) Master Inspection Characteristic to meet disposition due dates.
- Qualified In Cell bank Building 30 Batch Record Review.
Quality Assurance/ Lab Technician
REFRESCO
08.2019 - 07.2020
- Reviewed Documentation of Master Batch Records, logbooks, calibration records, temperature and humidity records.
- Managing & facilitating the sampling, analysis and reporting of microbiological quality of raw materials, Packaging material swabs, Environment sample.
- Inspect equipment prior to start up, calibrated equipment.
- Quality sampling and analysis of batching tanks, incoming tankers and all manufactured juice to ensure customer specifications are met.
- Conduced hazard analysis based both on food safety as well as general safety in order to provide safe working environment.
- Sampling, analysis and reporting of microbiological quality of Packaging materials, Environment samples (air/hand swabs/equipment's etc.), In process /Line samples, finished products.
Manufacturing (Aseptic Filling Operator)
TEVA PHARMACEUTICALS
07.2018 - 05.2019
- Qualified on class 5 and class 7 gowning.
- ·Responsible for the preparation of all filling machine parts for Sterilization.
- Filling Machine parts following good aseptic Techniques to minimize particulate contamination and per SOP's to insure Sterility.
- Complies with current SOP's and cGMPs Maintains Gowning Requirements set up and adjusts filling equipment settings to meet process parameters.
- Made Aseptic connections, Change pumps over of stoppering system.
- Safely Operates filling equipment and trouble shoots problems to ensure process Parameters are met throughout the run.
- Qualified on West Capper & Vial Washer
Manufacturing (Packaging)
AEROTEK/GILEAD SCIENCES
12.2014 - 07.2018
- Lead Team Of 7 Operators, Assigned daily tasks for line operations.
- Reviewer of all Batch Records of Packaging, Inspection, and Solid Dose.
- Monitored clean room operations to ensure compliance with FDA and GMP requirements
- Maintained control of quality records and material stored in Quality Control quarantine area.
- Qualified Machine Operator IMA Labeler, NJM Labeler. Performed weekly maintenance on machines, Troubleshoot and resolve problems, qualified on systech visions systems.
- Performed and documented visual inspection and physical testing of Incoming and in process components and finished products
- Reviewed all documentation from various locations (production,lab,inbound/outbound)
- Qualified Inspector of Gilead Products.
- Check- in and verified incoming components from various countries.
- Monitored production operations to ensure production standards were met.
- Quality/Trainer Trained and handled the on boarding of newly temps.
Education
High School Diploma -
Parkridge
Long BeachBiology
Oxnard College
Oxnard, CASkills
- Auditing and Compliance
- Punctual and Reliable
- Critical Thinking
- Data Entry Skills
- Organizational Skills
- Quality Assurance Skills
- Data Analytics
- Adaptable
- GxP Compliance
- Computer/Systems Skills
- Word
- Excel
- Power-Point
- SAP
- Maximo
- MES/PASX
- Track wise
- PI Vision
- Citrix/LIMS (Sample Manager)
- Veeva Vault/CDOC's
- Systech Visions Systems
References
- Juan Leica (310)-200-2037
- Janel Magana (760)-953-3039
- Veronica M. (760)-981-8145
Timeline
Senior Quality Assurance Associate
Amgen
08.2020 - Current
Quality Assurance/ Lab Technician
REFRESCO
08.2019 - 07.2020
Manufacturing (Aseptic Filling Operator)
TEVA PHARMACEUTICALS
07.2018 - 05.2019
Manufacturing (Packaging)
AEROTEK/GILEAD SCIENCES
12.2014 - 07.2018
High School Diploma -
Parkridge
Biology
Oxnard College