TrackWise JDEdwards Office
SAP UMS Compliance Wire Documentom Clin Pro Software Microsoft Excel Microsoft Word Microsoft Access Microsoft
Quality Analyst R&D 06/13 02//18
Review and approve all batch documentation for further processing and final release
of batch records such as certificates of analysis, certificate of conformance, API, bulk,
single panel and booklet labels in support of clinical studies.
Submit Clinical Trial Applications and Investigational Product Biologics Forms
to ensure batch is in compliance with regulatory filings and country regulations.
Maintain genealogy of API s, bulks, and packaging records for pilot plant.
Review and approve shelf life extension Forms, expiry memos and Stability tables as needed.
Coordinated the receipt, routing, tracking and final Quality Assurance review of all internal and third
Party Trackwise change controls, deviations, lab investigations and CAPAs.
Assisted in internal self inspections. Issued Quarantine memos.
Reviewed and approved Sampling and Inspection Forms for raw materials.
Maintained bulk / packaging log database.
Quality Distribution Associate 02/13 (Contract)
Catalent Pharrna Solutions
Review, document, and release all incoming drug and raw materials for clinical trials. Working knowledge of JDEdwards, Documentom, TrackWise, and Compliance Wire.
GMP Data Associate
ShireInc, Chesterbrook PA 06/12- 08/12(Contract)
Reviewed and modified employee training curriculum.
Conducted Audits of training data for all Shire Personnel utilizing TrackWise. Familiarwith Compliance Wire Database Management System.
Senior Quality Specialist 08/08 -06/10
Lonza Inc, Conshohocken PA
Reviewed completed process batch records, cleaning validaton records, labels,MO. temperature charts, validation data for accuracy and compliance.
Maintained the process batch record review database using the Electronic Document Management System. Tracked major process deviations, batchexceptions, and document errors.
Issued and maintained all completed production related documents such as batch records, labels, manufacturing orders, and validation data for production.
Initiated Document Retention database program to track & record operator errors. Generated and logged TrackWise deviations working closely with the Process Chemists and Production personnel to comply with Lanza policies.
Working knowledge with Access, Track Wise, Documentum,UMS,SAP, 21CFR, and IS09001 regulations. Worked with 40+ production personnel and supervisors on batch record corrections for all compliant release documentation.
Quality Assurance Specialist 01/06 -05/08
Bilcare Inc, Phoenixville PA
Supervised QC inspectors in Receiving, Distribution, and Approval of Clinical Supplies in a sterile manufacturing environment.
Reviewed and maintained environmental monitoring and temperature excursions for all drug
products in order to comply with customer requirements .
Written and reviewed Notice of Events, Corrective Actions, Discrepancy Reports and Customer Complaints .
Reviewed and approved all incoming component and drug documentation. Performed Internal Audits & approved swab test results for equipment use.
Reviewed and approved Temperature and Humidity trending data in Aseptic environment on
a daily basis.
Worked with Engineering to establish acceptable dimensional limits on incoming components .
Reviewed and approved Certificates of Analysis on all Drug Product prior to use.
Quality Assurance Specialist 5/05-09105(Contract)
Medimmune, Philadelphia PA
Responsible for internal auditing functions as well as implementation and maintenance of quality systems.
Performed Batch Record Reviews and oversee internal QC duties in Aseptic environment.
Packaging/Labeling Supervisor I0/03-ll /04(Contract)
Sanofi - Synthelabo, Malvern, PA
Supervised and trained 20 employees in all aspects of the clinical packaging and labeling process.
Coordinated and supervised the labeling processes in compliance with GMP and FDA regulations.
Tracked non-conforming material and alerted suppliers about these issues.
Reviewed and approved Packaging and Batch Records in a sterile manufacturing environment before and after clinical study for accuracy.
Updated labeling and packaging documents in accordance with company guidelines and GMP.
Worked with Zebra Printers and Clin Prosoftware.
Operated Kleckner EAS Blister Machines, CP-3 Blister Machines and ZED Carding Machines. Assisted indispensing raw materials from the warehouse inventory.
Worked with Electronic Inventory System, and UMS software.
Transferred Clinical Data to Company database.
Verified and approved label text incompliance with GMP.
Quality Control Coordinator 08/02-03/03(Contract)
Drug Plastics and Glass, Boyertown PA
Monitor and assign process parameters for 38 compression and injection mold machines.
Issue process exemption and deviation reports based on customer guidelines.
Interpret technical data and meet with manufacturing to recommend process improvements . Responsible for printing, reviewing, and releasing labels to production noor using Printpro Software.
Developed and revised Standard Operating Procedures and Quality Procedures. Performed trend analysis on suspect process variables.
Worked with a variety of SPC Software packages.
Represented the Quality Department in production schedule meetings. Maintain and upgrade Plant Star software as well as label database.
Network Quality Controller I0/98 - 08/01
Broadwing Inc., Norristown, PA
Supervised work order now to Field Technicians in an effort to meet customer deadline dates Followed up on customer complaints with corrective action report.
Maintained quality of orders by initiating daily conference calls with customers and
technicians to resolve any customer discrepancies.
Installed software packages for customers using Windows NT. Monitored and identified alarms on fiber optic system.
Quality Specialist 03/98 -10/98(Contract)
Cigna Corporation, Philadelphia, PA
Interacted with customers on a daily basis to upgraded software packages using Windows 95 andWindows NT resolving customers' software issues.
Ford Electronics, Hatfield, PA
Coordinated the flow electronic passive and active components in order to support manufacturing assembly plants.
Proficient inthe use of manufacturing management system (CMMS). Performed departmental as well as vendor audits.
Established a Quality Rating system for preferred suppliers .
Interacted with vendors on a daily basis in an effort to improve delivery times.
Bachelor of Science:Industrial Technology Binghamton University, Binghamton, NY
Diploma in Computer Networks and Data Communications The Chubb Institute, Springfield, PA