Summary
Quality specialist with over 11 years of professional experience in compliance, auditing, documentation, training, investigations, CAPA and AR&D. Internal auditor with extensive experience in FDA regulations, GMPs, GLPs, site SOP’s and general quality procedures. Comprehensively evaluates the impact of audit findings and identifies corrective and/or preventive actions, resulting in fewer reoccurrences. Supported over 20 development compounds in fast paced, GMP regulated environments.

Professional Experience

Confidential,Scientist/QC Analyst
Franklin Lakes, NJ (Feb2012-Present)
-Conducted studies to support the launch of protein therapeutics and vaccines in pre-filled syringes and other medical devices.
-Supported investigations of customer inquiries.
-Prepared testing and validation protocols and reports.
-Performed forced degradation studies, accelerated and real-time stability studies, and extractable/leachable studies on product/placebo stored in delivery systems.
-Troubleshot and maintained analytical laboratory equipment.
-Analytical and biophysical characterization techniques include: AAS, ICP/MS, FTIR, DLS, MFI, UV/VIS Spectroscopy, Semi Automatic syringe barrel liquid filling system, and Stopper Placement Unit (SPU) processing simulation.

Confidential,Senior QC Analyst
Ridgefield, NJ (Jul2011-Oct2011)(Contract Work)

Conducted analyses on raw materials, in process, and finished formulations in a CGMP laboratory to support manufacturing, product development and release of clinical materials.

• Reviewed QC data, batch records (BPR) for compliance to procedures and specifications, and reports abnormalities.
• Compiled data for documentation of test procedures.
• Prepared reports (validation, Non conformance), revised and updated SOPs as needed.

Confidential,QA Documentation Specialist
Totowa, NJ (Feb2011-Jun2011) (Contract Work)

Established systems and procedures to ensure product quality and compliance with cGMPs/PDMA, including quality reviews and recommendations for changes. Executed and tracked document review and approval process. Facilitated document initiation, change control and change of custody procedures. Reviewed and edited documents for approval. Controlled, distributed and maintained internal documentation procedures, data and records.
Wrote procedures and set up area in the NJ site for Document Control
Harmonized SOPs for 3 sites which are currently independent of each other

Confidential,Analytical Quality Sciences
Pearl River, NY (Jan2005 – Apr2010)

Reviewed more than 25 method validation and tech transfer reports/protocols for quality to expedite PAI readiness. Executed compliance based GMP audits and inspections, then evaluated and communicated audit findings to the group director. Followed up to ensure audit findings are appropriately addressed through CAPA. Retrieved all documentation, reports during pre-approval inspections and third party audit tours.
Reviewed more than one hundred SOP’s and STA’s to identify any necessary revisions to be made as a result of a PDIR CAPA
Audited the procedures of 40 analysts in multiple departments to determine compliance deficiencies
Tracked the progress of over 700 samples in LIMS as part of a PDIR for a data “clean up” and identified, delegated action items to analysts on a weekly basis
Issued investigation reports, change controls and equipment qualifications. Conducted maintenance checks to ensure good condition of equipment. Submitted work orders and performed minor repairs where appropriate. Communicated with vendors to source supplies and equipment. Trained new hires on skills and procedures.
Devised and maintained a monthly compliance list, thus leading to minimal laboratory audit findings
Reviewed notebooks for10 analysts (6 different projects) on a daily basis

Developed, authored, validated robust analytical methods and transferred them to supporting QC sites. Performed analytical analyses on a variety of drug products in a GMP-compliant manner (dissolution, KF, strength, purity and content uniformity testing).
Culled out and determined the status of all analytical and tracking information that were needed for a CAPA
Acted as a subject matter expert for several methods

Confidential,Assistant Scientist II, Analytical Development
Kenilworth, NJ (Sep2003-Jul2004)

Analyzed drug products in a cGMP environment (Dissolution, Moisture analysis, CU, Assay). Developed, authored and validated robust dissolution and moisture analytical methods. Ordered laboratory supplies for group on a balanced budget.

Confidential,Associate Scientist, AR&D
Pearl River, NY (Aug2001-Sep2003)

Analyzed drug products in a cGMP-compliant manner (Dissolution, CU, Assay/Imp). Developed, improved and validated analytical methods. Troubleshot, maintained and qualified laboratory instrumentation. Logged in LIMS, stored and managed the handling of laboratory samples.
Reviewed, edited and executed equipment IQ/OQ/PQ protocols

Confidential,Chemist, AR&D
Allendale, NJ (Sep2000-May2001)

Supported projects involving the use of GC/Headspace. Calibrated and validated laboratory equipment. Tested raw materials:

Education

ICH-GCP, GCP online training
B. A. in Chemistry, August 2000

• Softwares & Skills

MS Word, Excel, PowerPoint, Outlook, Publisher • Groupwise • EDMS
Windows • Internet Explorer • SAP • GxPharma • SharePoint • Citrix • Adobe Photoshop
Livelink • LIMS • Empower • Totalchrom • Chemstation • HPLC