Quality Assurance Customer Service

Vasanthi Rajamoorthi, M. Sc.

**** ***** ****. *******, ** 19067

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215-***-**** H. 267. 229.5975C ablktw@r.postjobfree.com

www.linkedin.com/ vasanthirajamoorthi

SUMMARY

Senior scientist with broad experience managing and coordinating pharmaceutical

clinical drug supply systems, i.e. APIs, Excipients, Packaging Components, Finished

Drug Products including Controlled Substances, and Reserve Samples. Proven

organization skills, detail oriented documentation, and accurate inventory management

skills aided me to identify by FDA inspector as expert in the maintenance of clinical

supply systems per GxP guidelines. Known for stream lining processes, reducing costs,

increasing productivity and data integrity. Dedicated to maintaining high quality

standards

MAJOR ACCOMPLISHMENTS

• Achieved 100% accuracy for every US and International clinical study supply

shipments in 15 years with Wyeth

• Received compliments and praise from customers and sponsor monitors with

comments like “you are making our jobs easier”. Received STAR award for

outstanding customer service

• Designed In House labeling systems that saved the cost of purchasing software

• Solved FDA drug notification mishaps by rewriting drug shipment procedures

• Increased quality and integrity of clinical shipment documents by designing new

shipping logbooks

• Chosen to be the API coordinator for the Princeton site due to my strong

demonstration of accountability and inventory skills

• Implemented state of the art systems for; API’s, Excipients, Packaging

components, finished drug products, controlled substances, retention samples and

chemical archives which received praise and appreciation from Internal QA

Auditors, Corporate Auditors, and FDA Inspectors

• Supported Quality Assurance and Regulatory Affairs departments by providing

necessary documents for Drug Master Files, and Chemistry Manufacturing and

Controls for products registration

PROFESSIONAL EXPERIENCE

Pfizer, (formerly Wyeth) Princeton, NJ

1995-2010

Scientist I, II, III, and Senior Scientist I, II

Clinical Supplies procurement and distribution Coordinator for APIs, Excipients, and

Packaging Components. Clinical Drug supplies distribution coordinator of finished drug

products including controlled substances for global GLP, and GCP trials. Retention

sample coordinator for GMP drug products, and chemical archivist for GLP materials.

Labeling batch coordinator for finished drug products manufactured in-house and

external production. Stability System Administrator for in-house stability studies to

support new product development.

• Procured and maintained accurate inventory of APIs, Excipients, and Packaging

Components, which kept labs functioning at peak performance. Coordinated with

Quality Control Department, and Quality Assurance Department for the GMP

release of APIs, Excipients, and Packaging Components ensuring smooth

operation. Dispensed GMP released materials for in-house batch production, also

shipped for various manufacturing sites

• Prepared and executed blinded and unblinded labeling batch operations for in-

house packaged clinical drug products using the Labeling Batch Record, a cGMP

Labeling Operation System. Assisted in-house GMP batch production operations

of various dosage forms, packaging the finished clinical drug products using batch

production record. Provided designed and approved label copy text for various

manufacturing sites for clinical drug products labeling

• Maintained accurate inventory of more than 30 clinical drug products. Reviewed

clinical study protocols and prepared clinical drug product shipments for global

study sites to enable new product development. Reconciled returned clinical drug

products for usage accountability. Maintained and organized shipping/tracking

records, which were readily retrievable for in-house QA audits, corporate audits,

and FDA inspections

• Performed inspection of controlled substance with Corporate Officer and Control

Substance Officer and issued reports. Conducted Annual Visual Inspection of

clinical drug products retention samples with Quality Assurance Auditor

documented and reported the results. Key member of AHRF team to assist annual

GMP/GLP auditing of department, documented action items

• Provided support for study directors and staff, including GMP Batch Production

operations and broaching studies. Verified technical reports and data for senior

staff. Performed physical testing of formulations following Standard Test

Methods (STMs), Standard Operating Procedures (SOPs), Good Laboratory

Practices (GLPs)

• Reviewed stability study protocols, assigned stability tracking numbers, labeled

and placed in appropriate chambers; maintained stability timelines, performed

stability pulls and coordinated testing and reported results to Study Director using

stability laboratory information management (SLIM) software

American Cyanamid Company- Biochemistry, Princeton, NJ

1995

Biologist

Primary and secondary drug screen for the invention of novel endectocide

Fox Chase Cancer Center- Biology Research Lab, Philadelphia, PA

1994

Lab Technician

Cloning and Nucleic acid isolation, Transformation of Yeast and E. coli.

Chemical preparations, Chemical identifications by thin layer chromatography

Madras University, Madras, India

1981-1983, 1985

Teacher

Taught science courses to high school students

EDUCATION

Madras University- Madras, India

Master of Science, M.Sc.

1983

Major: Zoology

Minors: Biochemistry, Biostatistics, and Biophysics

Madras University- Madras, India

Bachelor of Science, B.Sc.

1981

Major: Zoology

Minors: Botany and Chemistry

Bucks County Community College- Newtown, PA

1992-1994

Courses: Biological Principles, Survey of Organic Chemistry, Microbiology, and

Introduction to Computer Science and Genetics

University of Arizona- Tucson, AZ

1990

Chemistry 101

Attending RAPS study group and preparing for RAPS certification

In Progress

Preparing to get certificate in Certified Supply Chain Professional (CSCP)

TECHNICAL SKILLS

Microsoft Word, Excel, PowerPoint, Oracle Database, LIMS, and SLIM

TRAINING

Annual cGMP, GLP, and IATA training

CERTIFICATES

Workforce Development and Continuing Education - Montgomery Community College

May 2, 2010

Certificate of completion the course entitled Supply Chain Management Fundamentals

APICS The Association for Operations Management – successful completion of

May 25, 2010

Certified Supply Chain Professional

COMMUNITY SERVICE

• Volunteer at PAN APICS chapter

2010

• Vice President of Cultural Affairs for the Council of Indian Organizations

2008-2010

• Cultural Program Coordinator for the Tamil Nadu Foundation USA

2010

• Diversity Team Event Planner at Fort Dodge Animal Health

2009

• General Secretary for the Council of Indian Organizations

2006-2008

• President of the Tamil Association of Greater Delaware Valley

2004- 2005

• Vice President for the Federation of Tamil Associations of North America

2006

• Food committee organizer for Chinmaya mission

2001-2006

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