Lenka Foles
Atlanta,GA
Summary
Results-driven professional with 12 years of expertise in quality systems, compliance, and assurance across healthcare, manufacturing, pharmaceuticals, logistics, and software development. Proven track record in ensuring regulatory compliance, including OSHA, FDA, cGMP, ISO, HIPAA, SOC2, and NIST regulations. Efficient operations management skills in overseeing daily activities, managing teams, and driving process improvements.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Quality Assurance Engineer
LabLynx
05.2022 - 07.2024
- Utilized GRC software to analyze data, including policy management, risk assessments, vendor risk management, compliance audits, and security incident tracking; developed performance metrics and identified risk mitigation strategies for senior leadership
- Executed and presented a robust Corrective Action Program (CAPA) to ensure compliance with security regulatory requirements, internal policies, and controls
- Conducted thorough security evaluation through internal audits and reviews to identify gaps and pinpoint areas for improvement
- Implemented standard operation procedures (SOPs) and internal security controls following NIST 800-53 regulations utilizing Atlassian and JIRA applications
- Developed and tracked a Training Program ensuring ongoing employee awareness and compliance with security policies and controls
- Performed COTS LIMS software validation per SDLC phases
- Utilized AlienVault's SIEM system to generate reports to identify vulnerabilities and events and ensure the overall system security of the AWS cloud environments
- Tracked and reported CAPA Trend Analysis, key risks, and performance indicators to leadership and stakeholders regularly
- Conducted comprehensive OS patch testing to ensure the patch effectively addressed the identified security vulnerabilities to improve the system's security
- Collaborated on the preparation for the external cybersecurity audits.
Center Operations Manager
Grifols Biomat USA
11.2020 - 08.2021
- Directed and effectively managed a diverse team, day-to-day operations, training, and quality
- Worked closely with the Quality Team, increased the quarterly KPIs by 30%, and kept the score in good standing
- Ensured the facility remained in good standing regarding repairs, calibrations, and Preventive Maintenance
- Effectively managed corporate projects, including the development and implementation processes change during the transition to the new owner
- Conducted hiring and performance reviews and managed the center staff's ongoing personal development, competency, and performance
- Decreased customer complaints by 25% by conducting daily customer surveys and implementing solutions based on survey results
- Monitored and ensured the center's operating costs aligned with the monthly budget
- Managed inventory of all goods and supplies necessary for center operations and conducted ordering supplies as needed
- Minimized center liability through constant risk management review
- Investigated unsafe situations and established corrective/preventive action
- Developed and executed marketing strategies, increasing production revenue by 13% through promotions, cold calls, and local business partnerships.
Sr. Quality Assurance Specialist
Grifols Biomat USA
01.2019 - 10.2020
- Directed and monitored processes and ensured center compliance with state, federal, and company-designated regulations
- Reviewed and implemented the investigation, root cause, CAPA, validation plans, change controls, and reports
- Prepared and hosted Client and Regulatory Audits and ensured all requests were filled and submitted to auditors
- No FDA 483 citation was initiated during tenure
- I worked closely with the lab director to ensure the completion and accuracy of training for CLIA-related personnel and employees and proficiency testing
- Conducted trend error analysis to identify and implement preventive actions
- Worked closely with Operations, increasing the Key Performance Indicator (KPI) score by 40%
- Monitored hazardous waste disposal and product release requirements for the shipments
- Reviewed calibration and validation documentation to ensure technical accuracy, compliance, and completeness or to mitigate risks.
Quality Assurance Specialist II
ADMA Biologics
08.2017 - 12.2018
- Ensured compliance with all applicable state, federal, and European guidelines
- Reviewed and implemented deviation investigations, root causes, and CAPAs before final approval
- Assisted in developing policies and controls to ensure the requirements and rules were appropriately addressed to reduce or eliminate the potential of errors
- Prepared and analyzed QA reports for management review
- I hosted compliance audits for governmental agencies such as the FDA and PPTA
- No FDA citation 483 was initiated during my tenure
- Conducted vendor qualification and validation of new equipment
- Authorized final product release and ensured our product complied with customer specifications.
Quality Assurance Specialist
UPS Supply Chain Solutions
12.2014 - 05.2017
- Managed quality assurance operations and maintained quality compliance for pharmaceutical industry clients
- Ensured the safety of medical devices, vaccines, and products through careful monitoring and strict compliance with all client processes
- Facilitated training for new team members, ensuring a thorough understanding, and provided mentoring
- Achieved a 40% reduction in Non-Conformances by increasing the number of work adherence checks
- Drove NCR/CAPA (Nonconformance and Corrective Action Preventive Action) meetings with the Operations Management to coordinate the investigation of customer complaints
- Increased operational proficiencies by ensuring quality documentation is current and maintaining records in the e-QMS database
- Controlled quality by providing non-conforming products was identified and placed on restriction.
Quality Assurance Coordinator
Anitox
06.2012 - 11.2014
- Executed analysis and inspection of raw materials and finished products by applying titration methods and spectrophotometers and measuring purity by gas chromatography (GC) as written in QC/QA procedures
- Performed accurate recording of test data and applied statistical quality control procedures
- Served as the Backup to ISO Management Representative and was recognized for expertise in QAD software.
Microbiologist/R&D Technologist
Anitox
04.2009 - 05.2012
- Performed in vitro-vivo studies to evaluate the efficiency of newly developing products
- Led animal trials and monitored the effects of different product treatment levels
- Participated in projects, providing project support regarding new product launches
- Proficiency in BAX PCR System in analyzing food pathogens, yeast, and mold
- A key contributor to the launch of new products (Preserve-8 and Optiferm)
- Analyzed in-process samples and finished products to ensure product quality, uniformity, and safety
- Consistently met a required 10-day turnaround with a goal of 99% accuracy.
Education
Biology, B.S. -
Georgia State University
Bioscience Technology, AAS -
Gwinnett Technical College
Healthcare Science Certificate -
Gwinnett Technical College
Skills
- Software Quality Assurance
- Quality Management System
- Validation
- Auditing
- Compliance
- Operations Management
- Risk Management
- Cybersecurity
- Research & Development
- Infrastructure Security
Certification
- ISO 9001:2008 Lead Auditor Training (TPECS version) - Georgia Institute of Technology
- ISC2 Cybersecurity Professional (In Progress)
Career Milestones
- Developed an improved procedure for enumerating Clostridium perfringens (IPE, 2012) US/PLT Patent# PCT/US12/46821, 2012.
- Improved Application of Liquids to Solid Particles USDA Publication# 300652, 2014, Poultry Microbiological Safety and Processing Research.
- Promoted from the Sr. QA Specialist to Center Operations Manager (Grifols/BIOMAT USA). Led operational improvements and ensured compliance with quality standards while managing a diverse team.
- Developed and Implemented Compliance and CAPA Program aligned with NIST 800-53 framework. (LabLynx Inc.)
Languages
Czech
Native or Bilingual
Timeline
Quality Assurance Engineer
LabLynx
05.2022 - 07.2024
Center Operations Manager
Grifols Biomat USA
11.2020 - 08.2021
Sr. Quality Assurance Specialist
Grifols Biomat USA
01.2019 - 10.2020
Quality Assurance Specialist II
ADMA Biologics
08.2017 - 12.2018
Quality Assurance Specialist
UPS Supply Chain Solutions
12.2014 - 05.2017
Quality Assurance Coordinator
Anitox
06.2012 - 11.2014
Microbiologist/R&D Technologist
Anitox
04.2009 - 05.2012
Biology, B.S. -
Georgia State University
Bioscience Technology, AAS -
Gwinnett Technical College
Healthcare Science Certificate -
Gwinnett Technical College
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