Joyce Hynes
Quality Assurance Manager at Dexcel Pharma USA | Rockaway, New Jersey, United States
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Joyce Hynes serves as the Quality Assurance Manager at Edenbridge Pharmaceuticals, LLC, where she leverages her extensive 24 years of experience across the pharmaceutical, medical device, biotech, and personal care industries. In her current role, Joyce is instrumental in ensuring compliance with regulatory standards and maintaining the integrity of quality systems. As a key member of the Risk Evaluation and Mitigation Strategy (REMS) team for Vigabatrin, she plays a pivotal role in monitoring and managing the safety and efficacy of this critical medication. Her responsibilities include the review and approval of planned and unplanned deviations, as well as the assessment of adverse events and technical complaints, ensuring that all inquiries are handled with the utmost diligence.
Joyce’s expertise extends to her involvement with the Drug Supply Chain Security Act (DSCSA) Tracelink team, where she contributes to the implementation of robust tracking systems that enhance product traceability and security. She is adept at writing and submitting field alerts to the FDA, a critical function that underscores her commitment to patient safety and regulatory compliance. Additionally, Joyce oversees the release of batch records and lots in collaboration with warehouse operations, ensuring that only products meeting stringent quality standards reach the market.
Her proficiency in authoring, reviewing, and approving Standard Operating Procedures (SOPs) reflects her dedication to process excellence and continuous improvement. With a strong foundation in root cause analysis and CAPA management, Joyce is a creative problem-solver who excels in conducting gap analyses and driving quality initiatives. Her analytical skills and experience in global project management further enhance her ability to lead cross-functional teams in achieving key performance indicators and delivering high-quality pharmaceutical products. Joyce Hynes is not only a leader in quality assurance but also a vital asset to Edenbridge Pharmaceuticals, committed to advancing the standards of product quality and regulatory compliance in the industry.
Quality Assurance Manager at Dexcel Pharma USA in September 2022 to Present
Director Of Quality Compliance at Zennova LLC in November 2021 to February 2022
Senior Manager, Product Complaints at Par Pharmaceutical in August 2018 to November 2021
Manager, Product Complaints at Par Pharmaceutical in October 2014 to August 2018
Division Complaint Officer, CAPA Coordinator, Lead Auditor at Sultan Healthcare - A Division of Dentsply International in January 2011 to October 2014
Product Safety and Surveillance Consultant at Stryker Orthopaedics / Maetrics Consulting in September 2008 to December 2010
Complaint Specialist- Temporary position at Pfizer Inc / Avesta Inc. Consulting in June 2008 to July 2008
Global Quality Directive Project Manager- Consultant at Sanofi Pasteur - VaxDesign Campus in November 2007 to June 2008
Quality Assurance Manager at Strides Inc. in September 2006 to November 2007
Complaint Specialist at Schering-Plough Research Institute in March 2001 to June 2005
Quality Assurance Field Representative at Novartis Consumer Health in August 1999 to February 2001
Quality Assurance Specialist at Celgene in August 1998 to August 1999
Quality Control Assistant at Interferon Sciences Incorporated in April 1997 to April 1998
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Microsoft Word
Microsoft PowerPoint
Analytical Skills
Key Performance Indicators
IM
Computer Literacy
Problem Solving
Leadership
Organization Skills
Process Excellence
Product Quality
Root Cause Analysis
System Implementations
Good Laboratory Practice (GLP)
Project Management
Continuous Process Improvement
CAPA
FDA
Quality Assurance
Regulatory Affairs
Auditing
Analytical Chemistry
Quality System
Six Sigma
GLP
Medical Devices
Cross-functional Team Leadership
Pharmaceutical Packaging
Lean Manufacturing
Health Hazard Evaluations
SOP development
Sop
Change Control
Quality Control
Product Complaints
SOP
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
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What is Joyce Hynes email address?
Email Joyce Hynes at [email protected]. This email is the most updated Joyce Hynes email found in 2026.
How to contact Joyce Hynes?
To contact Joyce Hynes send an email to [email protected]. (updated on October 30, 2024)
What company does Joyce Hynes work for?
Joyce Hynes works for Dexcel Pharma USA
What is Joyce Hynes's role at Dexcel Pharma USA?
Joyce Hynes is Quality Assurance Manager
What is Joyce Hynes's Phone Number?
Joyce Hynes's phone (201) ***-*814
What industry does Joyce Hynes work in?
Joyce Hynes works in the Packaging And Containers Manufacturing industry.
Joyce Hynes Email Addresses
Joyce Hynes Phone Numbers
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