LISA A. KIMBALL
Danville,NH
Summary
Professional Surveillance Specialist with substantial experience in security and monitoring environments. Adept at leveraging advanced surveillance technology and analytical skills to maintain safety and prevent incidents. Strong emphasis on team collaboration and achieving measurable results while adapting to changing needs. Known for reliability, attention to detail, and problem-solving abilities.
Overview
19
19
years of professional experience
Work History
QA Post Market Surveillance Specialist
Fresenius Medical Care/Nxstage
Lawrence, Mass
04.2021 - Current
- Receives, reviews and processes routine product inquiries and product complaints for manufactured and distributed products (equipment, drug and device)
- Provided customer support and services as liaison between manufacturing facilities, distribution center, and customer/technical services.
- Create daily, monthly and weekly reports and sends them to proper people.
- Created cases of PT deaths and investigated incidents to determine underlying causes.
- Ensure complaints from multiple sources such as verbal, fax, and email are entered in the system.
- Interfaces with Customer Service and customers/PT to gather all additional info required for complaint.
- Maintained complaint files within the database environment using good documentation practices.
- Performed tasks remotely to maintain workflow
Senior QA Associate
Coherent
01.2018 - 04.2021
- Performs product inspections
- Performs line Audits
- Authoring Deviations
- Releasing products to clients
- Review of batch records
QA Raw Material Technician
AMRI
08.2017 - 01.2018
- Inspect and sample incoming material
- Perform Raw material sampling used in making of drug product
- Collaborating with QA Operations department on timelines for material review
- Write and Review Material Specifications
- Authoring of Deviations and CAPA
- Release materials
- Create COA-Make changes to procedures as needed
- Ship samples to 3rd party labs for testing and complete the appropriate paper work
- Perform chemical/component sampling
- Maintaining sampling supply inventory
- File and archive paperwork
- Create labels for finished product
Lead Warehouse Coordinator
MFG Tech. 3, BIO-CONCEPT LAB, INC
08.2015 - 08.2017
- Maintaining and setting up documentation
- Writing of SOP’s and Forms
- Proofread Documentation for MFG suites and send off for corrections
- Receiving all items coming into the warehouse
- Following up with all Documentation and Certificates needed for release and sampling for release
- Managing all product inventory and database, Product shipment
- Plan and layout work to meet production and schedule requirements
- Call and receive phone calls from vendors
- Environmental monitoring or suites
- Provide production in, Prep, Formulation, Fill and Inspection of product for clients
- Training new technicians on safety and procedures
Manufacturing Technician 3/ Documentation Specialist
UniQure
09.2015 - 08.2015
- Perform Manufacturing of UniQure therapeutic products following strict application of cGMP guidelines, monitoring and qualification of our manufacturing environment and systems
- Processes include, but not limited to, cell culture using shaker flasks, Bioreactors, purification steps, Ultrafiltration/Diafiltration and Final Fill of Drug Product, Inspection and packaging.
- Creating Documentation such as SOP’s (standard operating procedures), Forms and Batch Records.
- Training employees in cell culture process and General Aseptic Practices in BSC hood, prepare training documentation.
- Preparing suites for GMP use, which includes coordinating with the contractor to insure GMP readiness, organization of furniture orders and calibration of equipment needed for GMP use.
Manufacturing Associate & Manufacturing Technician 2
Amgen/Biovex
03.2008 - 08.2014
- Startup Company that focuses on the development and commercialization of biological treatments for cancer and the prevention of infectious disease, clinical phase 3 trials.
- Manufacturing in the suite includes making of buffers daily, set up equipment needed for auto Calving, vial washing, cell culture work, work under a BSC- hood, packing columns, work under a Microscope, purification, fill and finish activities.
- Documented batch records and forms as well as writing, reviewing and following SOP’s for equipment Going into the suite
- Managing the suite including ordering products needed to get the suite running, cleaning, stocking and Taking inventory to keep suite running, calibration daily of the ph meter and conductivity meter, Testing of samples daily, testing of filters
- Worked with incubators for cell culture
Education
High School Diploma -
Timberlane High School
Plaistow, NH01-1996
North Essex Community College
Haverhill, MASkills
- 20 years’ experience in the Biotech industry
- Able to manage multiple priorities, while maintaining high attention to detail, strong organization and time management skills
- Proficient in Microsoft, CATs Wed, Salesforce, Birst, SharePoint Comfortable learning new platforms and systems
- Excellent communication skills, personable and patient
- Able to work independently, as well as in a team setting and has a take charge attitude when leadership skills are required
- Provide training and instruction to new employees
- Writing of training documentation
- Management, writing of monthly schedules, ability to multi-task
- Data collection and management
- Self motivation
- Task prioritization
Timeline
QA Post Market Surveillance Specialist
Fresenius Medical Care/Nxstage
04.2021 - Current
Senior QA Associate
Coherent
01.2018 - 04.2021
QA Raw Material Technician
AMRI
08.2017 - 01.2018
Manufacturing Technician 3/ Documentation Specialist
UniQure
09.2015 - 08.2015
Lead Warehouse Coordinator
MFG Tech. 3, BIO-CONCEPT LAB, INC
08.2015 - 08.2017
Manufacturing Associate & Manufacturing Technician 2
Amgen/Biovex
03.2008 - 08.2014
High School Diploma -
Timberlane High School
North Essex Community College