Quality Assurance Manager
Resume:
Sarah Thompson
*** ******* **** ** ********** MA, 01430 *********@*****.***
Objective
Self-motivated, ambitious, and analytical individual with demonstrated science and leadership experience seeks a position in your company.
Education
graduated may 2003 - Westfield state college bachelor of science
Concentration in Microbiology
Honors: Deans List
Related coursework: Microbiology, Organic Chemistry, Physical Chemistry
Ben Gurion University 2001
Year abroad program
Continued my studies in Biology
Certificates
●HACCP
●MDR 2017/745 EU Medical Device Regulation Auditor
●ISO 13485:2016 Medical devices QMS Requirements for regulatory purposes Auditor
●ISO 14971:2019 Auditor
Skills & Abilities
Management
Communication.
Ability to Work Under Pressure.
Decision Making.
Time Management.
Self-motivation.
Conflict Resolution.
Leadership.
Adaptability.
COMPUTER SKILLS
MS Word
EXCEL
Power point
LIMS
SharePoint
ASANA
Matrix
Experience
QUALITY ASSURANCE CONSULTANT RQMIS September 2021-Present
●Developing, maintaining, and updating Quality Management System procedures, inspection instructions, and related documents for clients in support of product development, production, and post market activities.
●Audit Clients quality systems to assure compliance to the FDA’s QSR, ISO 13485, EU/MDR, and various other regulatory/standards requirements.
● Problem solve with and advise clients on quality issues
●Develop and implement tools for RQMIS employees in conducting their activities
●Complete complaint handling for clients
●Complete post market surveillance activities for clients
●Create and submit adverse event reports on clients behalf
QUALITY ASSURANCE MANAGER Kettle Cuisine September 2018-September 2021
●Manage QA personnel
●Conduct all company food safety, GMP, allergen control, HACCP and prerequisite program trainings
●Work with sanitation team on cleaning techniques and cleaning validation procedures
●Perform internal audits of facility and grounds
●Write and revise SOP’s
●Write all CAPA’S
●Perform duties in compliance with CGMP, GLP, and SOP
●Write and revise HACCP plan
●Write and revise HACCP documentation
●Manage all maintenance activities on site
●Perform routine inspections
●Lead role in Audit evaluations for FDA, USDA, SQF, and client specific audit
●Perform microbiological assays and quality assays
●Contribute to a team effort to ensure the efficient flow of work
●Document test results in an organized scientific fashion
●Perform and/or delegate all Quality Assurance tasks
●Responsible for trending environmental data
●Initiate, investigate and implement preventative/corrective action for deviations and OOS
QUALITY ASSURANCE MANAGER meninno brothers October 2017 - present
●Manage QA personnel
●Conduct all company trainings
●Write and revise SOP’s
●Write all CAPA’S
●Perform duties in compliance with CGMP, GLP, and SOP
●Manage all maintenance activities on site
●Perform routine inspections
●Lead role in Audit evaluations
●Contribute to a team effort to ensure the efficient flow of work
●Document test results in an organized scientific fashion
●Perform and/or delegate all Quality Assurance tasks
●Prepare and sent out contaminated samples for microbiological identification
●Responsible for trending environmental data
●Initiate, investigate and implement preventative/corrective action for deviations and OOS
LABORATORY coordinator, QUALITY CONTROL supervisor hans kissle april 2015- Octoboer 2017
●Lead microbiology analyst
●Supervise QC personnel
●Execute shelf life testing on all R+D products, and final products
●Execute tests on antimicrobial preservative effectiveness
●Conduct testing on all raw materials
●Training of other analysts
●Follow USFDA BAM, AOAC and other official methods
●Perform duties in compliance with CGMP, GLP, and SOP
●Write and revise SOP’S
●Perform duties in compliance with GMP, GLP, SOP, and aseptic technique
●Contribute to a team effort to ensure the efficient flow of work
●Document test results in an organized scientific fashion
ANALYST II ORGANOGENESIS INC SEP. 2012-APRIL 2015
●Sample and perform bioburden testing for WIFI, clean steam and Purified water
●Perform sterility, endotoxin and bioburden testing on raw material, in-process and final product using BacT/ALERT 3D microbial detection system
●In charge of equipment, making sure they are calibrated and working properly
●Environmental monitoring and personnel monitoring in class 100, class 10,000 and class 100,000 gowning qualifying individuals
●Prepare and sent out contaminated samples for microbiological identification
●Responsible for trending environmental data
●Initiate, investigate and implement preventative/corrective action for deviations and OOS
●Ensure QC Microbiology lab is in audit ready condition
●Tested samples for endotoxins using Pyros Kinetix and gel clot method
●Worked in cGMP, FDA and ISO 9001 regulated environment
●Performed growth promotion on media, and challenge test on final product
●Write and revise SOP’s
●Training of new analysts
●Perform TOC and conductivity testing on water samples
●Perform investigation into CAPA’s within the microbiology department
●Perform duties in compliance with GMP, GLP, SOP, and aseptic technique
●Contribute to a team effort to ensure the efficient flow of work
●Document test results in an organized scientific fashion
TEAM LEADER - UL STR (formerly Shuster Laboratories) – 2007-2009
●Act as supervisor to all other analysts in microbiology department, and liaison for all company questions and concerns regarding work done in microbiology department
●Execute tests on antimicrobial effectiveness, extraneous matter, microbial limits, and routine quality control or raw, processed and finished vitamin, herbal, food, OTC, and Rx products
●Training of other analysts
●Conduct microbial identification
●Follow USP, USFDA BAM, AOAC, and other official methods
●Perform duties in compliance with GMP, GLP, SOP and aseptic technique
●Contribute to a team effort to ensure the efficient flow of work
●Document test results in an organized scientific fashion
QUALITY CONTROL ANALYST- WYETH BIOPHARMACEUTICAL – 2006-2007
●LAL testing
●Bioburden testing
●Biological indicator strip and ampoule testing
●Environmental monitoring of pharmaceutical manufacturing suites
●Perform duties in compliance with GMP, GLP, SOP, and aseptic technique
●Contribute to a team effort to ensure the efficient flow of work
●Document test results in an organized scientific fashion
QUALITY CONTROL ANALYTS – SHUSTER LABORATORIES- 2004-2006
●Execute tests in antimicrobial preservative effectiveness, extraneous matter, microbial limits and routine quality control of raw, processed and finished vitamin, herbal, food, OTC, and Rx products.
●Conduct microbial identification
●Follow USP, USFDA BAM, AOAC, and other official methods
●Perform duties in compliance with GMP, GLP, SOP, and aseptic technique
●Contribute to a team effort to ensure the efficient flow of work
●Document test results in an organized scientific fashion
Language
English, Hebrew
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