Magen Livsey
Canton,USA
Summary
Motivated, personable Microbiologist with comprehensive knowledge of current Good Manufacturing Practices (cGMP), Good Lab Practices (GLP) and Quality Control Excellent interpersonal relations, communication skills and a team player General Skills: SOP Revision, Organizing, Multitasking, Time Management, Troubleshooting Equipment
Overview
19
19
years of professional experience
Work History
QC Analyst III, Microbiology
Organogenesis
Canton, MA
03.2016 - Current
- In charge of making the schedule for QC Microbiology department Oct 2016- Oct 2019 as Analyst II.
- In 2022 as Analyst III.
- Review document appendices for accuracy and GDocP compliance.
- Write and revise procedures (SOPs) using word processing and documentation databases.
- Participate extensively in high-level quality systems programs (CAPA, etc.)
- Perform endotoxin, microbiologic, and water testing using Pyros Kinetix System.
- Performing Utility Water for Injection testing on Endosafe Nexgen-MCS.
- Perform Final Product Bioburden and Sterility Testing of Apligraf.
- Perform routine Sterility Testing of final and in process samples using the BacT/ALERT 3D equipment.
- Perform visual inspection of finished product for Sterility testing.
- Perform raw material, intermediate and cell bank testing.
- Perform Plate Reads for EM and WFI/PW, Gram stain, Streak for culture and ship for Microbial ID.
- Schedule routine sample plans, Review and Approve samples in MODA.
- Perform routine Environmental Monitoring Including: Viable/Non Viable Air Monitoring, Surface Monitoring and Personnel Monitoring via Standard Operating Procedures (SOPs).
- Maintain a lab:, including inventory of lab supplies via OI Shopping List as well as general lab organization.
- Maintain office space: ordering supplies via WB Mason.
QC Technician II, Microbiology (Contract)
Shire HGT
Lexington, MA
03.2014 - 12.2014
- Determine microbial identification using a polyphasic approach including Gram staining, macroscopic and microscopic examination, supplemental testing and the Vitek 2 Compact.
- Initiate Microbial ID batches using the Laboratory Information Management System (LIMS).
- Collected crucial samples using SDA for a mold investigation.
- Perform routine Environmental Monitoring Including: Viable/Nonviable Air Monitoring, Surface Monitoring and Personnel Monitoring via Standard Operating Procedures (SOPs).
- Perform non-routine EM/Water sampling/testing in support of Validation/Manufacturing activities as directed by the sites.
- Perform peer review of assay data.
- Maintain lab, including inventory of lab supplies as well as general lab organization.
QC Analyst I, Microbiology
OPK Biotech LLC
Cambridge, MA
12.2012 - 12.2013
- Environmental Monitoring for controlled areas using the Met One and handheld RCS Air Sampler.
- Collect USP/EP purified, WFI and Clean Steam as required for TOC analysis and test according to Standard Operation Procedure for Bioburden as needed.
- Conduct tasks associated with preparatory testing for Microbial Identification such as gram staining.
- Assist in Microbial ID by Vitek 2 Compact.
- Utility sampling as required, (Nitrogen, Compressed Air, EM).
- Conduct Quality Control testing for media and other lab supplies.
- Reading plates and reporting results.
- Maintain labs, including maintenance of equipment, inventory of lab supplies as well as general lab organization.
Manufacturing Documentation Associate II
03.2011 - 12.2012
- Assisted with preparation for the implementation of Master Control.
- Trained MFG technicians on use of Master Control.
- Involved in coordinating the closing of Deviations.
- Responsible for organizing and converting all Manufacturing (MFG) documentation into the new company template.
- Acted as a liaison for MFG Dept working directly with the QA Department to solve any documentation lifecycle issues that occurred.
- Review, update and maintain department training documentation.
- Review, update, and maintain Batch Records, SOP’s, Activity Logs and cGMP forms for accuracy and adherence.
- Manage and trace documentation for change requests.
Manufacturing Documentation Associate I
04.2010 - 03.2011
- Responsible for organizing and converting all Manufacturing documentation into the new company template.
- Acted as a liaison for MFG Dept working directly with the QA Department to solve any documentation lifecycle issues that occurred.
- Review, update and maintain department training documentation.
- Review, update, and maintain Batch Records, SOP’s, Activity Logs and cGMP forms for accuracy and adherence.
- Manage and trace documentation for change requests.
Management/ Floor Lead
Sur La Table
Chestnut Hill, MA
07.2007 - 04.2010
- Responsible for opening and closing the store.
- Supervise and direct employees to ensure the completion of tasks and guarantee the satisfaction of customers.
- Accurately count draws for closing shift, verify, and record the deposit for the day.
- Multi-task: answer phone, ring out customer, and answer inquires of employees and customers.
- Organize and maintain the appearance of store to encourage and ensure selling of products.
- Assist and educate customers on products they are potentially interested to purchase.
Internship
Brighams and Women’s Hospital
Boston, MA
05.2006 - 12.2007
- Assisted Sr. Anatomical Pathology Technician in autopsy procedure.
- Obtained role to perform small medical procedures with minimal supervision.
- Responsible for maintaining the integrity of the autopsy suite and recording inventory.
- Facilitated with in hospital deliveries.
Education
B.A. - Biology
Pine Manor College
Chestnut Hill, MACertificate - Women in Leadership
Cornell University
Ithaca, NYSkills
- SOP Revision
- Organizing
- Multitasking
- Time Management
- Troubleshooting Equipment
- Environmental Monitoring
- Aseptic Technique
- Aseptic Gowning
- Bioburden Testing
- Pipetting
- Growth Promotion
- Water Sampling
- Gram Staining
- Plate Streaking
- Endosafe Nexgen-MCS
- Pyros Kinetix Flex Incubating Kinetic Tube Reader
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Master Control
- Microsoft PowerPoint
- LIMS
- TrackWise
- MODA
- Pilgrim SmartSolve
Timeline
QC Analyst III, Microbiology
Organogenesis
03.2016 - Current
QC Technician II, Microbiology (Contract)
Shire HGT
03.2014 - 12.2014
QC Analyst I, Microbiology
OPK Biotech LLC
12.2012 - 12.2013
Manufacturing Documentation Associate II
03.2011 - 12.2012
Manufacturing Documentation Associate I
04.2010 - 03.2011
Management/ Floor Lead
Sur La Table
07.2007 - 04.2010
Internship
Brighams and Women’s Hospital
05.2006 - 12.2007
B.A. - Biology
Pine Manor College
Certificate - Women in Leadership
Cornell University
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