Quality Assurance Control

Walter Fecica

** ****** ******, *******, ** *****

Home: 914-***-**** Cell: 914-***-**** email: *.******@*******.***

SUMMARY

Analytical Chemist with expertise in complete testing of finished dosage forms, stability samples and process validation utilizing assay, content uniformity, dissolution, identification methods and impurities by HPLC and TLC in strict compliance with all regulatory requirements.

• HPLC (Waters) • UV-VIS spectrophotometer •DISOL

• IR Spectrophotometer • Dissolution testers (VanKel, Distek) •QDIS

• Empower • QCSTAT •AQWA

EXPERIENCE

NOVARTIS, Suffern, NY Senior Scientist – Quality Assurance / Quality Control 2007 – 2015

Manage controlled substances from arrival in lab to preparation for destruction pickup, assuring adherence to DEA regulations

Manage annual year end internal DEA audits

Perform laboratory equipment decommissioning

Member of the Empower project for creating impurity processing methods for the testing group

Certified to conduct on the job training for new hires on general laboratory procedures, use and maintenance of laboratory instruments, and operating lab software (SAP, Empower, DISOL,QCSTAT) and safety procedures

Conduct weekly audit of laboratories to ensure compliance with both GMP and safety regulations

Evaluate anomalous results and conduct laboratory investigations

Validate and sign off electronic analytical data and review hard copy data and logbooks to ensure good data integrity

Manage complaint samples: register, assign tests needed and due date and report obtained results in AQWA system

Test variety of samples including product release, stability, complaint, process validation and method transfer samples. Perform Identity, Assay by HPLC and degradation products by HPLC and TLC; Content Uniformity by HPLC, Dissolution by HPLC and UV, Drug Release by HPLC in accordance with current regulatory guidelines

Received Business Excellence award in 2007 in recognition for significant involvement with extensive testing of process validation batches for qualification of Amlodipine Besylate for Lotrel Capsules

Scientist – Quality Assurance/Quality Control 1994 - 2006

Manage controlled substances from arrival in lab to preparation for pickup for destruction, assuring adherence to DEA regulations.

Manage annual year end internal DEA audits

Conduct on the job training for new hires on general laboratory procedures, use and maintenance of laboratory instruments, and operating of lab software (SAP, Empower, DISOL, QCSTAT)

Validate and review analytical worksheet packets and logbooks, ensuring good data integrity practice

Perform testing and validation on all varieties of release, stability, complaints and process validation samples

Received Business Excellence award in 1999 in recognition for contribution and commitment to teamwork and partnership in completing the Lotrel process validation on time

Associate Scientist – Quality Assurance / Quality Control 1991 – 1993

Maintain reference standard inventory

Order supplies for the laboratory

Member of the continuous express release team to release product in an expeditious manner

Coordinate the destruction of samples which have been tested and released

Validate raw data obtained by other analysts

Test finished dosage forms within time lines and in compliance with the testing procedures and current Good Manufacturing Processes

EDUCATION

Bachelor of Science, Chemistry

Manhattan College, Bronx, NY 1989

CERTIFICATION

Completed the New Jersey Pharmaceutical Quality Assurance (NJPQA) Certification Course.

Completed the Novartis Laboratory Analyst Certification Program.

ADDITIONAL INFORMATION

I volunteer in my son’s elementary / middle school showing the students basic hands on science experiments and asked to come back every year.

Walter Fecica Page 2

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