Quality Assurance / Production Support

DEBBIE TOBIN

* ********* ****

Basking Ridge, NJ 07920

Res: 908-***-****

Cell: 908-***-****

QUALITY ASSURANCE / PRODUCTION SUPPORT

Comprehensive Quality Assurance experience with the Medical Devices Division of Johnson & Johnson and Drug Manufacturing at Faulding Inc., Purepac Pharmaceutical. In-depth knowledge of FDA, ISO and GMP Standards. Experienced and well versed in Auditing, SOP Development, Validations and Quality Training. Thorough understanding of Manufacturing and Packaging Operations.

EXPERIENCE

IKARIA SYSTEMS, Clinton, NJ 10/05

Manager, Corporate Quality

Developed and implemented a device quality system that encompassed all Ikaria standards and ISO 13485 requirements. Oversaw new device manufacturing startup process and scale up activities including site location, equipment selection and quality control systems.

Conducts vendor audits to ensure ability to meet all Ikaria quality and production requirements. Develop and maintain corporate Quality policies as pertains to device manufacturing operations. Participate in and/or lead special assignments including validation, product failure investigations, training and process change management. Participate in Quality taskforce assignments. Act as liaison and problem solver within the Quality group. Assist in and/or lead regulatory body inspectional readiness efforts as appropriate. Conduct quality audits of Ikaria facilities including Regional Service Centers ,UHS and manufacturing sites.

BIOPURE, Souderton ,PA 11/02-10/05

Quality Assurance Senior Compliance Specialist

Reviewed production records for compliance with cGMP’s and internal standards. Coordinate product release by tracking lot history of related deviations investigations and assuring timely review of product record with QC. Conducted routine compliance monitoring checks throughout the plant and reported on findings. Conducted and wrote investigation reports to determine root cause of product failures and environmental monitoring excursions. Provided training to QA and other departments as part of on-going effort to elevate the plant-wide level of compliance with cGMP’s.

IMCLONE SYSTEMS INCORPORATED, Somerville, NJ 6/01-8/02

Supervisor, Quality Assurance Inspection

Supervised six Quality Assurance Inspectors, assisted in training and development as required to assure cGMP compliance. Support supplier certification program. Wrote Standard Operating Procedures and created raw material and component specifications as needed. Performed line clearances for biotech manufacturing processes and participated in internal audits of the manufacturing areas. Established inspection schedules to meet production demands. Finalized verification and release of product and facilitated tracking and trending of raw materials for further processing. Developed, reviewed and approved Standard Operating Procedures for quality assurance and raw material inspection areas.

ALPHARMA, INC., Purepac Pharmaceutical, Elizabeth, NJ 2/99-6/01

Quality Assurance Supervisor

Supervised twelve-core group Quality Assurance Inspectors, assisted in training and development. Assured cGMP compliance. Analyzed technical scientific information and

presented to internal and FDA Auditors. Revised and implemented improvements to quality systems. Resolved daily quality and manufacturing issues. Assisted Quality management team with ongoing action plans. Worked with System Manager for critical Product Discrepancy Notifications (PDNs) Database. Coordination of finished product release involving completion of manufacturing batch record review, packaging and analytical review and confirmation of any outstanding PDNs or Validation Reports. Ensured update of reviews and reports in MFG Pro 2 System. Performed trend analysis discrepancy requests and recommended improvements if corrective action was needed. Performed Project Management and assisted Quality Assurance upper Management with specific requests.

ETHICON, INC., Somerville, NJ (a Johnson & Johnson Company) 12/80-11/98

Quality Assurance Supervisor

Supervised twenty-five Quality Assurance technicians supporting Suture Manufacturing and Sterilization departments. Performed investigations and signed off on corrective and preventive action non-conformances; wrote reports summarizing data compiled during projects and new process protocols. Assisted during FDA and Regulatory in-process audits. Periodically conducted audits in other plant locations. Implemented cross-training program for technicians, which maximized manpower and reduced overtime 40% generating a $60,000 cost savings. Assumed Department Manager role during absence of Manager with no disruption of department performance. Implemented program for operator certification and annual re-qualification program for technicians.

EDUCATION - Middlesex High School, Middlesex, NJ

SPECIAL TRAINING

• Good Manufacturing Practices •How To Supervise People

• Primary Supervisors Operations Training •Introduction to the Personal Computer

• Excel & Microsoft Word •GMP / ISO Training

• Quality Education System

– Philip Crosby Association •Certified for Kaizen

• Certified ISO 13485

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