Darlee Alexander
Quality Management Consultant at AQC Alexander Quality Consulting | Macungie, Pennsylvania, United States
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As the Director of Quality Assurance at LAMPIRE BIOLOGICAL LABORATORIES, Darlee Alexander plays a pivotal role in ensuring that the organization adheres to the highest standards of quality and regulatory compliance. With a robust background in Quality Management Systems (QMS), Darlee specializes in ISO 13485:2016 and ISO 9001:2015 standards, as well as FDA 21 CFR Part 820 regulations. Her expertise encompasses a wide range of critical areas, including risk management, change control, and supplier management, which are essential for maintaining the integrity of the manufacturing processes and ensuring that products meet stringent quality criteria.
Currently, Darlee is leading several key projects aimed at enhancing the effectiveness of the QMS across all Lampire facilities. This includes the planning and implementation of comprehensive internal auditing processes to identify areas for improvement and ensure compliance with FDA, USDA, and EU regulations. Her hands-on experience with process validation and analytical development allows her to effectively oversee technology transfers and process development initiatives, ensuring that all operational changes are seamlessly integrated and compliant.
Darlee’s commitment to quality is further exemplified through her proficiency in root cause analysis and corrective action processes, which are vital for addressing any deviations in quality control. Additionally, her knowledge in companion diagnostics and PCR optimization positions her as a valuable asset in the drug discovery landscape. By fostering a culture of continuous improvement and rigorous training programs, Darlee not only enhances the capabilities of her team but also drives the overall mission of Lampire to deliver high-quality biological products that meet the evolving needs of the industry.
Quality Management Consultant at AQC Alexander Quality Consulting in August 2023 to Present
Quality Assurance Manager - North America at Valtech Corporation in October 2024 to Present
Director of Quality Assurance at LAMPIRE BIOLOGICAL LABORATORIES in August 2022 to August 2023
Quality Systems - Senior Manager, North America at PPG in September 2014 to May 2022
GMP Technology Transfer Manager at IntelligentMDx in March 2013 to July 2014
Analytical Scientist at Novartis in February 2011 to March 2013
QC/PD Scientist - Cell / Molecular Biology at Histogenics in January 2010 to October 2010
Design Assurance Engineer at Insulet Corporation in January 2009 to October 2009
Quality Assurance Manager at Osmetech Molecular Diagnostics in March 2008 to December 2008
Senior Research Associate / Technical Lead at Osmetech Molecular Diagnostics in July 2005 to March 2008
Quality Control Lead at Tepnel Lifecodes Corporation in August 2003 to July 2005
Lead Laboratory Technician at Tepnel Lifecodes Corporation in July 2000 to August 2003
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FDA
Validation
GMP
ELISA
Sop
Assay Development
PCR
CAPA
Laboratory
Immunoassays
GLP
Gel Electrophoresis
Biochemistry
Pharmaceutical Industry
ISO 13485
DNA
Technology Transfer
qPCR
Medical Devices
Quality Assurance
Molecular Biology
DNA extraction
Genetics
Purification
Quality Control
LIMS
Cell Culture
Cell
Hardware Diagnostics
RT-PCR
Analytical Chemistry
Design Control
V&V
Protein Chemistry
Immunology
Quality System
Fluorescence
Biopharmaceuticals
21 CFR Part 11
Clinical Trials
Lifesciences
R&D
Biotechnology
HPLC
Immunohistochemistry
Chromatography
Laboratory Automation
real-time PCR
Microbiology
Drug Discovery
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What is Darlee Alexander email address?
Email Darlee Alexander at [email protected] and [email protected]. This email is the most updated Darlee Alexander email found in 2026.
What is Darlee Alexander phone number?
Darlee Alexander phone number is +16173475469.
How to contact Darlee Alexander?
To contact Darlee Alexander send an email to [email protected] or [email protected]. If you want to call Darlee Alexander try calling on +16173475469. (updated on November 04, 2024)
What is Darlee Alexander net worth?
Darlee Alexander has an estimated net worth of $150,000 to $249,999
What company does Darlee Alexander work for?
Darlee Alexander works for AQC Alexander Quality Consulting
What is Darlee Alexander's role at AQC Alexander Quality Consulting?
Darlee Alexander is Quality Management Consultant
What industry does Darlee Alexander work in?
Darlee Alexander works in the Biotechnology Research industry.
Darlee Alexander Email Addresses
Darlee Alexander Phone Numbers
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