Summary
Overview
Timeline
Skills
Proficiencies
Work History
Education
Generic

Amelia Baechtel

QC Microbiologist / Team Lead
Germantown,MD

Summary

Dynamic leader and skilled QC Micro Analyst, highly effective at working in team-based settings with focus on promoting efficiency and quality innovation.

Excels in solution-oriented collaborative projects with emphasis on high quality output and attention to detail. Proven expertise in aseptic techniques and rigorous compliance with SOP guidelines over 5+ years of Biomanufacturing experience.


Currently interested in further developing skills in quality leadership, managing quality deviation investigations and CAPA solutions, and compiling/ managing trend report and validation projects.

Overview

6
6
years of professional experience
1
1

Year of leadership experience

Timeline

Scientist III - Team Lead

Eurofins PSS
10.2023 - Current

Scientist II

Eurofins PSS
06.2022 - 10.2023

QC Analyst I

Macrogenics
10.2020 - 01.2022

Manufacturing Associate

Aerotek - Thermo Fisher Scientific
03.2020 - 10.2020

Laboratory Support Specialist

Aerotek - Lonza
06.2019 - 12.2019

Associate of Science - Biotechnology

Montgomery College
08.2015 - Current

High School Diploma -

Col. Zadok Magruder High School
08.2012 - 06.2015

Skills

Project Management

undefined

Proficiencies

Software:

  • LabVantage LIMS
  • Veeva Vault
  • EndoScan
  • MasterControl
  • Blue Mountain
  • Microsoft Office
  • Oracle Cloud Management


Lab Equipment:

  • Biological Safety Cabinet (BSC)
  • SAS Air Sampling Unit / Single and Duo head samplers
  • Beckman Coulter Met ONE 3400
  • Serological Pipet-Aid and Micropipette
  • Milliflex Oasis Filtration System
  • EndoSafe nexgen-MCS
  • Sievers M9 TOC Analyzer


Lab Practices:

  • Cleanroom Gowning
  • Aseptic donning of PPE
  • Cleanroom behaviors
  • Equipment preventative maintenance and routine cleaning
  • On-the-job training
  • Data integrity
  • ALCOA+

Work History

Scientist III - Team Lead

Eurofins PSS
Frederick, MD
10.2023 - Current
  • Promoted to Team Lead in October 2023
  • Coordinated team responsibilities and oversight of upcoming projects and required trainings.
  • Represented and promoted team and company during third-party professional events.
  • Actively involved in talent acquisition and building of a skilled professional team focused on quality and client satisfaction.
  • Collaborated with team members to perform tasks and ensure timeliness and accuracy upon completion.
  • Received recognition from client management for effective managing of several complex cross-functional projects, such as EMPQ validation of BSL-2 / ISO 5 cleanrooms and technical studies for process improvement, meeting all pertinent milestones.
  • Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
  • Proposed an optimized scheduling system to fellow Team Leads as a solution to a 30% increase in workload, and implemented the system successfully.
  • Participated in multiple high-visibility internal deviation investigations and ownership, compiling data from cross-functional sources and provided an in-depth analysis of quality events and actions taken to mitigate and resolve issues presented.
  • Edited and managed review of technical documentation and SOPs to align with current GLP guidelines.

Scientist II

Eurofins PSS
Frederick, MD
06.2022 - 10.2023
  • Followed SOPs to comply with GMP and GDP standards.
  • Conducted weekly routine Environmental Monitoring activities in cleanroom suites and accurately recorded data into LIMS promptly.
  • Management of weekly and quarterly water system sampling and performing Bioburden Analysis on collected samples.
  • Accurate and thorough read and review of 250+ media growth plates used for EM and Bioburden, on average, per week.
  • Performed microbial identification, subculture, and processing of collected EM samples and reported results for trending purposes.
  • Management of scheduling and performance of Personnel Monitoring and Gowning Qualifications for the ISO-5 cleanroom environment for all GMP-compliant employees.
  • Support of non-routine functions and projects such as EMPQ, APV, and IOQ/PQ validations to support client expansion.
  • Recognized as Associate Team Lead in April 2023 to support team in absence of a Team Lead
  • Managed additional responsibilities as Associate Team Lead such as development of weekly team schedule and assignment of tasks, and collaborating with other shifts to ensure timely completion of weekly duties.
  • Promoted to Team Lead in October 2023

QC Analyst I

Macrogenics
Rockville, MD
10.2020 - 01.2022
  • Compiled and distributed weekly feedback to team leaders to improve and streamline daily QC activities.
  • Followed SOPs to comply with cGxP standards.
  • Conducted weekly routine Environmental Monitoring activities in cleanroom suites and accurately recorded data into LIMS promptly.
  • Compiled and organized sample recovery excursion notices and reports, and participated in and initiated OOS investigations.
  • Management of routine PW and WFI sample collection and performed Bioburden Analysis and TOC testing using M9 Sievers TOC Analyzer, Endotoxin, pH and Conductivity monitoring, and bench chemistry testing for Silicates, Chlorine, and hardness.
  • Accurate and thorough read and review of media growth samples collected from EM and Bioburden.
  • Performed monthly Gram Stain assays / organized Microbial Identification for third party shipment and reported results for trending purposes
  • Developed quarterly trend reports of all Environmental Monitoring related processes to be submitted to quality management, including excursion and OOS deviation reports.

Manufacturing Associate

Aerotek - Thermo Fisher Scientific
Frederick, MD
03.2020 - 10.2020
  • Complied with cGMP and cGDP standards to manufacture and prepare reagents and customer products.
  • Supported machine operators in setup and operation of production equipment resulting in efficient runs.
  • Inspected finished products for quality and adherence to customer specifications.
  • Filled over 3000 vials of therapeutic customer product per day while maintaining 100% accountability and quality.

Laboratory Support Specialist

Aerotek - Lonza
Frederick, MD
06.2019 - 12.2019
  • Maintained routine upkeep and inventory of ISO 7-5 cleanroom environment while adhering to cGMP standards.
  • Recorded information, shortages and discrepancies to keep records current and accurate.
  • Kept up-to-date and accurate laboratory batch-records and QA documentation in comprehensive filing systems.
  • Documented and digitally archived sensitive physical QA documents to ensure ease of access for future use and ALCOA+ preservation.
  • Assisted Laboratory Technicians with preparation of production instruments and batch records for cleanroom use.

Education

Associate of Science - Biotechnology

Montgomery College
Rockville, MD
08.2015 - Current

High School Diploma -

Col. Zadok Magruder High School
Rockville, MD
08.2012 - 06.2015

Similar Profiles

CREATE PROFILE
Amelia BaechtelQC Microbiologist / Team Lead