Experienced, results-oriented professional with broad experience in pharmaceutical quality processes and problem solving. Expertise in reviewing complaints, SOPs, Batch Records, and other documentation for accuracy and completeness. Skilled in preparing for internal or external audits and correcting deficiencies. Demonstrated ability to bring new facilities into FDA compliance. Proficient in SAP and Trackwise. Areas of expertise: PQMS | Batch Record Review | Controlled Substances | Document Control FDA Regulations | Metrics Reporting | GMP / GLP, OSHA

1. CASSIA RICCIONI
Keyport, NJ 07735 908.303.7196
www.linkedin.com/in/CassieRiccioni cassieslnj@gmail.com
QUALITY ASSURANCE PROFESSIONAL
Identify quality manufacturing trends and investigate solutions
Experienced, results-oriented professional with broad experience in pharmaceutical
quality processes and problem solving. Expertise in reviewing complaints, SOPs, Batch
Records, and other documentation for accuracy and completeness. Skilled in preparing
for internal or external audits and correcting deficiencies. Demonstrated ability to bring
new facilities into FDA compliance. Proficient in SAP and Trackwise. Areas of expertise:
PQMS | Batch Record Review | Controlled Substances | Document Control
FDA Regulations | Metrics Reporting | GMP / GLP, OSHA
PROFESSIONAL EXPERIENCE
Actinium Pharmaceuticals Inc., Edison, NJ 2016 – present
Senior Quality Associate
• Reviewed Manufacturing Records and released product for clinical use.
• Participated in SOP development, training and implementation
• Entered and checked stability data in Excel
• Reviewed and approved Master Batch Records, Deviations and CAPA’s
JANSSEN SUPPLY GROUP, a division of J&J, Raritan, NJ 2007 – 2015
Quality Associate
• Reviewed product complaints in the PQMS system, ensuring complaint was
categorized correctly for metrics reporting and escalating as needed.
• Requested investigations from internal and external manufacturing sites, reviewing
results for accuracy and completeness and closing complaint.
• Monitored metrics for trends by analyzing reports, identifying defects and escalating
as needed for investigation or recall.
• Created weekly and monthly reports in Excel which demonstrated number of
complaints for each site, providing data for site managers and quality management
team.
JEIVEN PHARMACEUTICAL CONSULTING, INC., Scotch Plains, NJ 2003 – 2007
Senior Quality Compliance Associate

2. • Performed batch record review and release, ensuring materials were manufactured
according to specifications and safe to be released for use.
• Conducted in-house quality control for contract sites, pulling samples during runs,
recording materials were correct, as well as pulling retain samples to send to lab.
• Acted as 3rd party monitor at contract packaging sites, overseeing operations from
time product arrived at airport through shipment to clinical site.
Assured quality, safety and compliance to Good Manufacturing Practices (GMP's) by
checking and reviewing work completed.
• Wrote Standard Operating Procedures (SOPs) which established quality standards
and documented processes used in manufacturing, ensuring consistency as well as
compliance with federal regulations.
• Prepared for internal and external audits by verifying documentation was up-to-date
and accessible and machines were calibrated, following up to ensure deficiencies
were corrected and documented.
NOVADEL PHARMA, INC., Flemington, NJ 2002 – 2003
Production Supervisor, GMP Compliance Coordinator
Conducted inspections and completed documentation for adherence to GMP standards
for manufacturing, packaging and labeling operations, ensuring accuracy and FDA
compliance.
• Supervised production staff, including line supervision, and packaging of bulk drug,
ensuring correct materials and labeling were in place and GMP's were followed.
• Developed defined GMP program for clinical manufacturing by writing batch records
and verifying employee training as well as ensuring equipment was clean and
calibrated, supplies were from approved vendors, and Certificates of Compliance
were current.
ADDITIONAL EXPERIENCE
NEXMED, East Windsor, NJ
Operations Line Supervisor
MEDAREX, Annandale, NJ
Laboratory Technician
EDUCATION
− Registered Nurse coursework, Belmont Technical College, Saint Clairsville, OH
− Mental Health / Human Services coursework, Franciscan University of Steubenville,
Steubenville, OH