Donna Callery
Director of Quality Assurance at Oligo Factory | Bellingham, Massachusetts, United States
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Donna Callery serves as the Director of Quality Assurance at Oligo Factory, where she leverages her extensive 30 years of experience in the Medical Device and Pharmaceutical industries to drive excellence in quality management systems. In her current role, Donna leads the implementation of a comprehensive Quality System designed to comply with stringent regulatory standards, including 21 CFR 820, ICH Q7, and ISO13485. Her expertise in these areas is critical as Oligo Factory specializes in the manufacture and analysis of synthetic oligonucleotides, which are pivotal for applications in research, diagnostics, therapeutics, and molecular biology.
Under Donna's leadership, Oligo Factory has successfully established robust quality systems that encompass essential processes such as Management Review, Deviations, Non-Conformance Material Reports (NCMRs), Corrective and Preventive Actions (CAPA), and Change Control. Her strategic approach to quality metrics ensures that the organization not only meets regulatory requirements but also fosters a culture of continuous improvement and operational excellence.
Donna's proficiency in FDA regulations and her deep understanding of Good Laboratory Practices (GLP) position her as a key player in the life sciences sector. Her ability to navigate complex compliance landscapes while implementing effective quality assurance strategies has been instrumental in enhancing product reliability and safety. As a results-driven leader, Donna is committed to advancing Oligo Factory's mission of delivering high-quality oligonucleotide products that meet the evolving needs of the scientific community.
Director of Quality Assurance at Oligo Factory in April 2023 to Present
Principal Supplier Quality Engineer at Medtronic in June 2017 to April 2023
Associate Director of Quality at Quanterix in August 2015 to April 2017
Director of Quality Assurance/Quality Control at Americanbio, Inc. in July 2011 to August 2015
Lead QA Specialist at Anika Therapeutics in February 2010 to June 2011
Quality Assurance Manager at SeraCare Life Sciences in January 1992 to January 2003
QA Manager at J&S Médical in January 1998 to January 1999
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Quality Procedures
Quality Metrics
ICH
CAPA
GMP
FDA
Change Control
GxP
Quality Assurance
Biotechnology
Validation
Commercialization
21 CFR Part 11
Sop
Quality Control
Team Leadership
PowerPoint
Strategic Planning
GLP
Aseptic Processing
Lifesciences
Life Sciences
Medical Devices
Trackwise
SOP
Quality System
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
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Discover more about Oligo FactoryWhat is Donna Callery email address?
Email Donna Callery at [email protected]. This email is the most updated Donna Callery email found in 2026.
What is Donna Callery phone number?
Donna Callery phone number is +15088838806.
How to contact Donna Callery?
To contact Donna Callery send an email to [email protected]. If you want to call Donna Callery try calling on +15088838806.
What is Donna Callery net worth?
Donna Callery has an estimated net worth of $750,000 to $999,999
What company does Donna Callery work for?
Donna Callery works for Oligo Factory
What is Donna Callery's role at Oligo Factory?
Donna Callery is Director of Quality Assurance
What industry does Donna Callery work in?
Donna Callery works in the Biotechnology Research industry.
Donna Callery Email Addresses
Donna Callery Phone Numbers
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