FRANCESCA RANDAZZO-ANDERSON
Sr. Change Control Specialist
West Sand Lake,NY
Summary
Developed skills in cGMP environment, focusing on process optimization and system troubleshooting. Skilled in identifying inefficiencies and implementing solutions to enhance operational performance. Seeking to transition into new field, leveraging strong technical background and problem-solving abilities.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Sr. Change Control Specialist
Regeneron
Rensselaer, New York
01.2024 - Current
- Ensured compliance with industry standards and regulations through thorough documentation of all control-related activities.
- Participate in cross-functional study teams to facilitate manufacturing production and lot disposition.
- Review, edit, and revise controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures.
- Monitor production processes to obtain necessary data in support of investigations and track effectiveness of changes.
- Guide junior team members in developing their professional skills through mentoring and coaching, leading to increased productivity and enhanced quality of work.
Sr. Biotech Compliance Coordinator I
Regeneron
Rensselaer, New York
12.2020 - 01.2024
- Served as liaison between management and staff on matters related to ethics, integrity, and compliance concerns or inquiries.
- Collaborated with cross-functional teams to address any identified compliance issues promptly.
- Reviewed documents, files, transcripts, and other records to assess compliance and potential risk.
- Promoted compliance by advising management on needed or prohibited actions to comport with government regulations.
- Managed complex projects involving multiple stakeholders, ensuring alignment with organizational goals while maintaining focus on regulatory requirements.
Biotech Compliance Coordinator III
Regeneron
Rensselaer, New York
01.2018 - 12.2020
- Served as liaison between management and staff on matters related to ethics, integrity, and compliance concerns or inquiries.
- Improved compliance by developing and implementing comprehensive policies and procedures.
- Reviewed controlled documents in accordance with cGMP standards to ensure compliance with written procedures
Regualtory Affairs Specialist
CURIA
Rensselaer, New York
10.2017 - 01.2018
- Prepared and submitted regulatory file applications and supporting documentation.
- Recommended improvements to processes.
- Drafted amendments of regulatory guidance for the FDA.
- Prioritized project-related tasks such as creating Drug Master Files (DMF) for FDA to efficiently complete essential tasks.
- Maintained and archived regulatory paperwork.
Quality and Regulatory Specialist
Nobilium
Albany, NY
05.2017 - 08.2017
- Enhanced regulatory compliance by developing and implementing robust policies and procedures.
- Worked closely with legal counsel to address any concerns related to noncompliance or regulatory investigations.
- Assisted in the negotiation of licensing agreements, protecting company interests while meeting regulatory requirements.
- Conducted thorough risk assessments to identify potential compliance issues and develop effective mitigation strategies.
- Established a strong culture of compliance throughout the organization by promoting awareness and accountability at all levels.
- Recommended improvements to processes, including training the company on GMP rules and regulations.
Integrated QA Specialist
Eurofins Lancaster Laboratories
Lancaster, Pennsylvania
08.2016 - 03.2017
- Primary liaison between laboratory departments and Quality Assurance
- Reviewed and revised completed Batch Records for compliance with written procedures
- Investigated and closed deviations using various LEAN Techniques
- Conducted walkthroughs of laboratories for compliance risks
- Reviewed laboratory logbooks in accordance with cGMP Standards
- Conducted room clearance for production laboratories
- Conducted and documented all trainings such as SOP and Documentation Excellence for various departments
- Reviewed and revised internal documents and SOPs
Compliance Specialist
GLAXOSMITHKLINE
Marietta, Pennsylvania
12.2015 - 06.2016
- Reviewed, revised and authored SOPs in accordance with cGMP standards to ensure compliance
- Lead Investigator for Deviations for the Value Stream Packaging and Logistics department
- Created CAPAs to identify various gaps
- Developed Job Aids that are currently in use throughout the company
- Assisted investigation and risk management teams with investigations and risk identification.
- Reviewed, revised and authored documents such as SOPs for compliance and regulatory needs
Quality Assurance Compliance Associate
Cytovance Biologics
Oklahoma City, Oklahoma
10.2012 - 06.2014
- Managed and coordinated Supplier/Vendor Audit Assessments for a CMO to demonstrate compliance with FDA and partner company standards
- Followed-up with companies on all overdue Supplier/Vendor Assessments to show FDA Compliance, as well as, ensuring all certificates are current
- Generated reports for Supervisor and Director to show progress of Assessments returned for the quarter
- Cross referenced all Batch Records and Standard Operating Procedures (SOP) trainings to ensure that all parties were compliant and properly trained
- Reviewed Batch Records and training documentation for completeness
- Conducted Internal Audits to maintain compliance and meet company’s standards
- Assisted with incoming shipment paperwork in the warehouse and revised Material Specifications to ensure Warehouse inspections for incoming products can be conducted faster and more efficiently
Quality Assurance Associate
HUMAN GENOME SCIENCES, INC.
Rockville, MD
01.2010 - 10.2012
- Reviewed Good Manufacturing Practices (GMP) records and data, managed Learning Management System (LMS) and ensured regulatory compliance by overseeing training requirements for all HGS employees and Support internal and third party/regulatory agency audits, i.e
- FDA, EU and various other countries
- Administrator for LMS system and maintained GCP, GLP and GMP practices
- Assisted in upgrade of company-wide Learning Management System (LMS)
- Created and managed courses, classes, curricula and assignments as needed within LMS
- Reviewed, edited, and approved SOPs for effectiveness and compliance risks
- Reviewed all training documentation for completeness and compliance with Good Documentation Practices
Education
Bachelor of Science - Political Science
State University of New York College At Oneonta
Oneonta, New York 01.2007 - 05.2007
Skills
- Project Management
- Quality Assurance
- FDA Regulatory Requirements
- Quality Improvement
- Quality Risk Management
Certification
Six Sigma Yellow Belt
Timeline
Sr. Change Control Specialist
Regeneron
01.2024 - Current
Sr. Biotech Compliance Coordinator I
Regeneron
12.2020 - 01.2024
Biotech Compliance Coordinator III
Regeneron
01.2018 - 12.2020
Regualtory Affairs Specialist
CURIA
10.2017 - 01.2018
Quality and Regulatory Specialist
Nobilium
05.2017 - 08.2017
Integrated QA Specialist
Eurofins Lancaster Laboratories
08.2016 - 03.2017
Compliance Specialist
GLAXOSMITHKLINE
12.2015 - 06.2016
Quality Assurance Compliance Associate
Cytovance Biologics
10.2012 - 06.2014
Six Sigma Yellow Belt
06-2011
Quality Assurance Associate
HUMAN GENOME SCIENCES, INC.
01.2010 - 10.2012
Bachelor of Science - Political Science
State University of New York College At Oneonta
01.2007 - 05.2007
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