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Customer Service Quality Assurance

Spring Valley, New York, United States
January 16, 2017

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Mary J. Scott

*** ******* **. ****** ******, New York 10977 845-***-****

Quality assurance and production operator. Professional with proven abilities in manufacturing, quality oversight and maintaining quality standards aligned with U.S. FDA guidelines. Achieved a long history of professional promotions.

Key Skills include:

Customer Service v OSHA Safety Regulations v Technical Problem Solving v Lab Procedures / Documentation

cGMP / SOPs v OSHA / FDA Safety Regulations v Policies & Procedures v Productivity v

Laboratory Testing v Microsoft Word & Excel

Nice Pak-Orangeburg, New York 5-201*-**-****

Quality Assurance Inspector (Temp-Consulting)

Responsible for day-to-day in process quality checks across manufacturing lines to ensure all finished goods meet product specifications. Performed daily inspection of all production lines to assume compliance to GMPs and company. Ensured that all manufacturing specifications for components labeling and product are correct, clear and complete. Inspected work areas for removal of all previous products and components. Verified readiness of work areas prior to use. Monitored and inspected in-process finished product for quality. Applied appropriate disposition label to material. Accurately and completely documented all inspection information on Daily Inspection Report. Submit Production samples to Micro-biology labs.

Novartis Pharmaceuticals- Suffern, New York 01-201*-**-****

Documentation Specialist (Temp) Consulting

Responsible for timely and effective GMP review and production close-out of batch record documentation in order to maintain a continuous flow of right the first time batch records to QA. Responsible for review of in house audits as per the Federal Government.

Production Packaging Operator

Operator disassembled, assembled, monitored and maintained various packing equipment throughout the Packing Process.

Participated in a high performing work team to maintain the effectiveness of key pharmaceutical equipment through various stages of the packing process. Maintained and kept detailed records of all processing. Performed second checks for batch records. Adhered to all SOPs, cGMPS, safety and other departmental rules and regulations.

Macy’s, Nanuet, New York 2006- 2015

Sales Associate/Customer Service (part time)

Provided personalized sales assistance to customers in the Women’s Department by providing advice on business suits, evening gowns and accessories. Provided personalized sales assistance to customers in Coach Handbags.

Provided personalized sales assistance to customers in the Men’s Department by taking measurements for custom tailored suits, to ensure a well fitted suit.

Offered sales advice to customers on all areas of clothing and accessories.

Wyeth Pharmaceuticals/Pfizer - Pearl River, New York 2003-2008

Quality Assurance Oversight Specialist

Provided quality oversight and guidance for the manufacturing process when critical processing steps are conducted for bulk operations.

Responsible for a diverse and challenging set of activities, all of which were related to setting and maintaining quality standards aligned with U.S. FDA. Those are current Good Manufacturing Practices (CGMP) and other applicable international GMP regulations.

Worked effectively on project teams and provided services to manufacturing operations which improved overall efficiency. Reviewed SOPS, participated in local, research, and corporate audits and corrected deficiencies as required. (out-of-specification investigations)

Assured appropriate consistency in GMP systems applied across both clinical and licensed products.

Active Member of the following teams:

Risk Management Team which successfully improved the Prevnar Process.

Batch Record Risk Management Team which effectively reduced errors by 10% by introducing new strategies.

Valve Change Elimination Team improved causes and effects, such as data analysis results, tubing issues studies, specifications and acceptance criteria.

Logbook Reduction Team achieved and eliminated errors in production logbooks.

Change Control Committee improved a written procedure that describes proposed actions for equipment in a manufacturing facility.

Quality Assurance documentation for production areas.


Senior Laboratory Technical

Prepared various records for daily media batch preparation, such as mathematical calculations, media buffers, and weighed raw materials utilizing filtration apparatus to filter media.

Determined correct pH by using analytical balances, pH meters.

Prepared weekly glassware and raw material inventories used in the solution preparation.

Performed weekly environmental monitoring in class 100,000 areas. Daily cleaning of batching vessels was done to prepare media.

Weekly changing of record charts and daily reading of temperature recorders.


Technical Assistant, Validation

Executed Installation Qualification (IQ), Operations Qualification (OQ) and Performance Qualification (PQ) protocols for validation of equipment and processes.

Assisted in the preparation of final reports by organizing validation data into charts, tables and graphs through testing, sampling, and monitoring assignments.

Calibrated critical test instruments used in validating equipment.

Updated list of validation books and inventory of released biological indicators.

Coordinated various aspects of projects’ work to be performed with Department Supervisors.

Analyzed data results against established acceptance criteria.

Investigated failing results and suggested corrective actions.

Technical Assistant, Quality Control in Vitro Testing

Lead Bio- Operator Fill Finish 1989-1994

Maintained clean, sterile conditions in sterile rooms.

Performed initial dose checks of completed documents for completeness and accuracy.

Challenged inspection machine for rejects by manually inspecting (50-100) syringes for defects.

Used manual and automated packaging systems to label, inspect and package final container products. Maintains records, and manufacturing/production area to comply with regulatory requirements. Also, good manufacturing practices and standard operating procedures.

Education / Professional Development

Bachelor of Science - Health Care Administration

University of Phoenix, Phoenix, Arizona

Associate Degree - Liberal Arts Mathematics & Science

Rockland Community College, Suffern, New York

Risk Management Seminar

Lean Six Sigma Simulation Workshop

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