Summary
Overview
Work History
Education
Skills
Timeline
Generic

Andrew Meyer

St. Albans,MO

Summary

This resume highlights my career experience, education and unique skills. With over 15 years of experience in the Pharmaceutical and Medical Device Industry

Overview

17
17
years of professional experience

Work History

Quality Systems Specialist

Steris Corporation
10.2024 - 06.2025
  • Lead and participate in supplier evaluations, audits, and assessments (on-site and remote) to determine their capability to meet our quality, regulatory, and technical requirements for products.
  • Collaborate with R&D, Procurement, and Manufacturing to define supplier selection criteria and ensure new suppliers are qualified according to established procedures.
  • Develop and maintain Approved Supplier Lists (ASL) and associated documentation.
  • Establish and monitor key performance indicators (KPIs) for supplier quality, including defect rates, on-time delivery, and responsiveness to issues.
  • Conduct regular supplier performance reviews and provide feedback to suppliers.
  • Issue, track, and close Corrective and Preventive Actions (CAPAs) and Supplier Corrective Action Requests (SCARs) related to supplier non-conformances.
  • Work closely with suppliers to implement robust root cause analysis and effective corrective actions for quality issues.
  • Perform and support supplier risk assessments for critical components and materials, identifying potential failure modes and developing mitigation strategies.
  • Ensure suppliers have robust risk management processes in place that align with product safety and efficacy.
  • Review and approve supplier change notifications to assess the impact on product quality and regulatory compliance.
  • Ensure appropriate validation and verification activities are performed for supplier-initiated changes.
  • Collaborate with R&D during product design and development to ensure supplier capabilities meet design requirements and specifications for new products.
  • Support the selection of critical components and materials from qualified suppliers.
  • Support internal and external audits (e.g., FDA, Notified Body) related to supplier quality and provide necessary documentation and evidence.
  • Ensure all supplier quality activities are compliant with FDA 21 CFR Part 820, ISO 13485, IVDR (EU 2017/746), and other relevant international IV regulations and standards.
  • Maintain accurate and complete supplier quality records.
  • Drive continuous improvement initiatives with suppliers to enhance quality, reduce costs, and improve efficiency.
  • Develop and deliver supplier quality training as needed.

Quality Assurance Specialist

Bausch & Lomb Surgical
03.2021 - 09.2024
  • Work with Manufacturing, Engineering, Site and Regional Quality, Planning and Shipping personnel daily at the St. Louis Cat/Vit facility.
  • Supervise production personnel in manufacturing of vitrectomy cutter devices. Direct and assist with manufacturing engineering technical work, as necessary.
  • Interface with Planning to understand production schedule and meet production requirements in a timely manner.
  • Ensure compliance of components, assemblies, and products to design requirements through physical, visual, and specialized testing.
  • Document results in accordance with all pertinent procedural requirements.
  • Create, validate, and implement test processes to ensure component/product compliance.
  • Work with QA and Engineering to resolve production line quality issues.
  • Conduct routine environmental monitoring in accordance with documented procedures.
  • Perform in process inspections and final inspections on the disposable pack product line. Perform and document results of inspections per company procedures.
  • Interpret and implement various statistical tools including ANSI standard sampling plans, Process control charts, Capability analysis.
  • Create, update, and implement procedures and work instructions in regard to inspections.
  • Utilize computer applications such as word processing, to develop spreadsheets and databases. Use these skills to document and analyze quality inspection data.
  • Utilize basic problem-solving tools (fishbone diagrams, pareto analysis, etc.) to improve products and or processes.
  • Perform and track environmental parameters of the disposable pack operations (clean room, gowning room, transfer room, packaging)

Sr. Biopharmaceutical Technician Downstream Protein Purification

Thermo Fisher Scientific
12.2018 - 11.2020
  • Responsible for the performance of operations in support of the manufacture of Commercial and Clinical Biologics. By following cGMPs, I carried out a variety of functions related to Upstream (cell culture) and Downstream (purification) bio-pharmaceutical manufacturing. These processes included propagation of mammalian cell culture, conducting aseptic cell culture operations, execution of large-scale production bioreactors scale up (50L-2000L) through Harvest. Primarily conducting large scale chromatography phases, viral inactivation, viral filtration, ultrafiltration and diafiltration, as well as aseptic filling of bulk drug substance.
  • Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation.
  • Able to execute all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
  • Acts as On-The-Job-Trainer for a variety of job functions
  • Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.
  • Critical evaluation of processes, including foresight and thinking ahead.
  • Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine troubleshooting.
  • Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly.
  • Perform timely consumption of materials and completion of quality documentation in appropriate systems (SAP)
  • Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations. Work to complete documentation of deviations and events in appropriate systems
  • Execute validation protocols with minimal supervision or direction
  • Participate in cross-functional teams to complete projects
  • Lead shift exchanges and daily huddles for team as required. Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on a variety of techniques

Quality Assurance Technician

Bausch Health
08.2018 - 12.2018
  • Work with Manufacturing, Engineering, Site and Regional Quality, Planning and Shipping personnel daily at the St. Louis Cat/Vit facility.
  • Ensure compliance of components, assemblies, and products to design requirements through physical, visual, and specialized testing.
  • Document results in accordance with all pertinent procedural requirements.
  • Create, validate, and implement test processes to ensure component/product compliance.
  • Conduct routine environmental monitoring in accordance with documented procedures.
  • Perform in process inspections and final inspections on the disposable pack product line. Perform and document results of inspections per company procedures.
  • Interpret and implement various statistical tools including ANSI standard sampling plans, Process control charts, Capability analysis.
  • Create, update, and implement procedures and work instructions in regard to inspections.
  • Utilize computer applications such as word processing, to develop spreadsheets and databases. Use these skills to document and analyze quality inspection data.
  • Utilize basic problem-solving tools (fishbone diagrams, pareto analysis, etc.) to improve products and or processes.
  • Perform and track environmental parameters of the disposable pack operations (clean room, gowning room, transfer room, packaging)

Manufacturing Technician II

MilliporeSigma
10.2016 - 08.2018
  • Followed and maintained batch records, Standard Operating Procedures (SOP’s), to ensure Good Manufacturing Process (cGMP) of liquid media for cell culture.
  • Filling of both bags and bottles varying in size from 500L to .5ml
  • Prepared filter schemes for sterile filtration of liquid media
  • Prepared filter housing equipment and various fill equipment
  • Followed intensive sterilization procedures that includes; disinfection of cleanroom, donning and doffing of the cleanroom PPE.
  • Followed good documentation practices, use of Systems Applications and Products (SAP) program
  • Environmental monitoring to ensure sterility during aseptic fills
  • Collected active air samples, use of Hach particle counters, and agar plates (i.e. touch, settle, passive) to monitor cleanroom and personnel for sterile and aseptic environment
  • Followed proper procedures for disinfection of the cleanrooms and sporklenz of cleanrooms
  • Preparing autoclave loads, bowie dick and leak testing of autoclaves
  • Manual CIP of small parts and portable tanks, setting up stationary tanks for automated CIP and SIP
  • Ph testing, osmolality testing, conductivity testing, pipetting, daily use of laboratory tools and equipment
  • Following quality controls sampling requirements for all manufactured products

Production Technician

Meridian Medical Technologies
09.2008 - 03.2016
  • Performed pharmaceutical manufacturing operations in a FDA regulated cGMP environment according to Batch Manufacturing Record (BMR) specifications
  • Operated pneumatic, automatic and manual manufacturing process equipment of varying complexity in production processes in accordance with Standard Operating Procedures (SOP’s)
  • Demonstrated batch instructions for dispensing of materials, physical testing, product inspection, packaging, labeling of various products and general support of the manufacturing operation
  • Room and equipment cleaning, machine set-up and daily checks to support the manufacturing operation
  • Continuous training on Standard Operating Procedures (SOP’s) to remain current for job requirements
  • Gained experience in Good Manufacturing Procedures (GMP) manufacturing, gown and clean room environment, working with sterile production equipment and processes
  • Responsible for line clearances before and after production lots to avoid cross contamination of batches
  • Used proper documentation when entering data in batch records, logbooks, forms and controlled documents.

Education

Bachelors of Applied Science (AAS) - Information Technology (IT)

ITT Technical Institute of Technology
Arnold, MO
10.2009

Skills

  • Quality Systems Management
  • Batch record review
  • Writing and revising of SOP’s
  • Strong Leadership Qualities
  • BioHazardous Material Management
  • Quality Assurance
  • Lean Manufacturing
  • Upstream Cell Culture/Harvest
  • Chromatography
  • Viral Inactivation
  • Titrations
  • Viral Filtration
  • Ultrafiltration/Diafiltration

Timeline

Quality Systems Specialist

Steris Corporation
10.2024 - 06.2025

Quality Assurance Specialist

Bausch & Lomb Surgical
03.2021 - 09.2024

Sr. Biopharmaceutical Technician Downstream Protein Purification

Thermo Fisher Scientific
12.2018 - 11.2020

Quality Assurance Technician

Bausch Health
08.2018 - 12.2018

Manufacturing Technician II

MilliporeSigma
10.2016 - 08.2018

Production Technician

Meridian Medical Technologies
09.2008 - 03.2016

Bachelors of Applied Science (AAS) - Information Technology (IT)

ITT Technical Institute of Technology

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Andrew Meyer