Nivia Baez
QA Compliance Specialist at Anika Therapeutics | Acton, Massachusetts, United States
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Nivia Baez is a dedicated QA Compliance Specialist at Anika Therapeutics, where she leverages her extensive experience in quality assurance systems within the pharmaceutical and medical device sectors. With a strong focus on Corrective Action and Preventive Action (CAPA) processes, Nivia plays a pivotal role in ensuring that the company adheres to stringent regulatory standards, including cGMP and FDA GMP guidelines. Her expertise encompasses a wide range of quality assurance functions, including investigations, complaint management, product disposition, internal audits, and document change control, making her an invaluable asset to the organization.
In her current role, Nivia serves as the primary batch record reviewer, meticulously evaluating batch records to ensure compliance with established protocols before release. She is responsible for providing essential batch record information to customers, which underscores her commitment to maintaining transparency and quality in operations. Additionally, Nivia conducts GMP reviews on forms, printouts, and charts generated from both Operations and Quality Control laboratories, ensuring that all documentation meets the highest standards.
Her proactive approach to quality assurance is complemented by her skills in statistical problem-solving techniques and QA documentation review, which enable her to identify trends and implement effective solutions. Nivia's involvement in the stability program further demonstrates her comprehensive understanding of product lifecycle management. As a back-up for the issuance and assignment of lot numbers and expiration dating for manufacturing and engineering documents, she ensures that all processes are executed with precision. Through her dedication and expertise, Nivia Baez continues to enhance the quality systems at Anika Therapeutics, contributing to the development of safe and effective biopharmaceutical products.
QA Compliance Specialist at Anika Therapeutics in December 2011 to Present
QA Specialist at Blue Stream Laboratories in October 2011 to December 2011
Senior QA Compliance Specialist at Formatech Inc. in April 2008 to August 2011
Quality Assurance Facilitator at Mayne Pharma (PR) Inc in September 2003 to April 2007
Quality Assurance Supervisor at Faulding (PR) Inc in January 2001 to August 2003
Release Coordinator at Faulding (PR) Inc in January 1998 to December 2000
Quality Assurance Incoming Technician at DuPont-Merck Pharma in April 1995 to December 1997
Small Volume Parenteral Inspector at DuPont Pharma in January 1995 to March 1995
Quality Assurance In-Process Technician at DuPont Pharma in November 1988 to December 1994
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University of Puerto Rico, Mayaguez, BS, November 1981 to November 1985
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Eye For Detail
Bilingual
User Experience
cGMP
CAPA
Inspection
SOP
Quality Systems
Quality Assurance
GxP
Pharmaceuticals
Quality Auditing
Investigations
Change Control
Private Investigations
Sop
HPLC
Regulatory Affairs
Process Improvement
FDA
Medical Devices
GLP
LIMS
Trackwise
Aseptic Processing
Analytical Chemistry
Biopharmaceuticals
Technology Transfer
Cleaning Validation
FDA GMP
Microbiology
Computer System Validation
cGMP practices
ISO 13485
Chromatography
cGMP manufacturing
Aseptic Technique
Biotechnology
Regulatory Submissions
GAMP
GDP
Quality System
GMP
TrackWise
Pharmaceutical Industry
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Discover more about Anika TherapeuticsWhat is Nivia Baez email address?
Email Nivia Baez at [email protected] and [email protected]. This email is the most updated Nivia Baez's email found in 2026.
How to contact Nivia Baez?
To contact Nivia Baez send an email to [email protected] or [email protected]. (updated on September 04, 2024)
What company does Nivia Baez work for?
Nivia Baez works for Anika Therapeutics
What is Nivia Baez's role at Anika Therapeutics?
Nivia Baez is QA Compliance Specialist
What is Nivia Baez's Phone Number?
Nivia Baez's phone (413) ***-*327
What industry does Nivia Baez work in?
Nivia Baez works in the Pharmaceuticals industry.
Nivia Baez Email Addresses
Nivia Baez Phone Numbers
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