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Quality Control

Murrieta, California, United States
October 30, 2016

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Nadia Spolar

Cell: 858-***-**** 224-***-**** Email:

Objective: Providing Superior Customer Value & Support. Business Manager with 18 years of experience focused on meeting financial goals, production deadlines and meeting superior quality metrics. Proven experience working in fast paced environment where making agile decisions had direct impact on the department and organization. Researches, evaluates, recommends, tests, and configures hardware and software technologies, presentations, and all other needs.

Customer Focused Technically Savvy Quality Specialist Driven for Success

Technical Skills:

Remedy Help Desk, LAN/WAN applications, Adobe, Oracle-Inventory, Share Web, Touchpoint, EDMS software

Document and Record Management, Visio-process mapping, Live Link, Google application, AQL inspections– FAI sampling

Microsoft Word, Excel, Access, Internet Explorer, Outlook; Word Perfect, Lotus Notes, Goldmine, FileNet

Proficient in using Digital Test Instruments and applications, QUMAS CompliancSP, ISO 13485:2003

HIPAA Trained - cGMP Practice, Maintained Regulation 21CFR820, EHS documentation, 5S processes and standards

Project Management Trained, Oracle database, Lean Six Sigma, HP Printing Systems


USPS – California April 2015- Present

Quality Control Specialist

Manage Customer Concerns; Responsible for receiving, tracking, assessing, and responding to customer issues. Responding in 24 hours and closing on-time with a competent response including working with suppliers to identify Root Cause and implement corrective actions

Manage Root Cause, Corrective, Preventive Action, Risk-Based Thinking Implementation

Manage and support Continuous Improvement Processes; utilizing customer feedback, SCAR/CAR findings, Manager review meetings and Wabtec’s WPS/QPS system requirements. This includes COPQ measurable and other key quality metrics

Produce product inspection standard documentation. Create presentation to outline daily, weekly and monthly trends.

Conduct internal and customer audits. Work with regulatory agencies, certification agencies and clients conducting audits. Lead qualification activities associated with First Articles parts as Purchasing transitioned to alternate suppliers

Develop and maintain an ongoing plan to eliminate errors in manufacturing, warehouse, and other areas and assist in developing an ongoing training program for production operators and assembly technicians

Provide direct supervision to: Quality Inspectors - whose functions include inspection of in process and finish jobs and Receiving Inspectors - whose functions include inspection of incoming raw materials

Design and document best practices for content entry. Map data flows to support business operations.

Document and maintain content definitions, ownership, and quality rules.

Monitor quality of content and make sure that quality issues are identified, documented, and prioritized. Train content contributors with a range of expertise on the importance of following good data-entry and management processes.

Work with other departments to make sure that employees understand how to use the content-management system properly to drive best-in-class business practices.

NESC – Genentech – Roche Company Feb. - Dec.2014

Quality Project Specialist

Developed and managed the ISO Internal Auditor Team on updating and revising processes, procedures, instructions, efficiency, productivity, training, and service delivery. Maintained the Quality plan, document and data control and CAPA system. Perform validation, integrity and data analysis for various systems - report results to Client Teams.

Monitor quality analysis performance of suppliers and external manufacturer's. Maintain quality logs.

Establish inspections and test methods for assigned product documentation lines.

Participate in technical assessments and quality system audits of suppliers to identify potential area of risks, process variability and address root causes. Demonstrate proficiency in statistic, demand planning and forecasting methods.

Work with all departments to review documentation for other possible improvements or efficiencies. Follow up to ensure document updates identified are completed in a timely manner.

Identifies and manages risk throughout the development process with the use of FMECA and/or other risk management tools. This includes leading the Risk management efforts of the design process and working with design team and management team on managing product and process risks. Assist with periodic review of all SOPs and other procedural documents to ensure that documents reflect current practices. Check documents for regulatory submissions to Regulatory Affairs for accuracy and completeness. Creation, evaluation, and validation of product and process test methods.

Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives. Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.

Identify, communicate, and escalate as appropriate control issues and process inefficiencies; recommend and assist with implementation of control and process improvements. Represent department on corporate projects.

Work with Department Management and IT to maintain a systematic program for back up of all R&D and GxP relevant data records.

Lead and support teams to investigate quality issues, resolve complaints, non-conforming products and CAPA.

Provide support to develop and maintain good documentation practices -GMP for the Validation Process, specifications, manufacturing, safety and test procedures under FDA rules and regulations.

Participate and collaborate with Supply chain and R&D department to identify potential areas of process variability and implement improvements. Populate the ShareDrive with .pdf copies of controlled documents.

Worked with Business Units to document, standardize, log, monitor and track contract and product changes and overall assist in establishing process change control. Perform filling set up system for easy document retrieval.

Maintained master system data portfolio to ensure user database reflects correct data information including user budget, statistical reports data, evaluate and solve business challenges in quality and timely manner.

Assisted supervisors and managers with set up, analysis, data flow, streamline generation of reports. Developed ad-hoc reports, Triage requests and performed maintenance as needed.

Managed Safety, Health and Environment and project management staff the improvement of business processes to develop supporting content on daily basis. Actively represent Quality Assurance function on product/process development teams.

Support the BMSO, Technology, Production, Manufacturing senior technicians and lead departments by working effectively to meet department production goals, objectives and tasks to achieve desired results.

Canon Business Services (formally Oce) 2010 to 2013

Site Implementation Manager - Adventist Hospital

Directed a team of employees across five departments to optimize quality and output of the customer document management, administration and call center. Delivered projects as defined within the constraints of scope, quality, time and costs in order to meet the project budget objectives and to achieve high customer satisfaction while providing 100% Technical support for all end users.

Examined adherence to Six Sigma standards in development and implementation of production applications, documentation and the effectiveness of the assurance process – perform change orders/ECO processing.

Supervise and participate in the Document Control functions of document fulfilment, release, change, and archiving

Interfaced with customers on a daily basis regarding the delivery of the projects that are defined within the constraints of scope, quality, time, inventory and costs in order to meet the project budget objectives and to achieve high customer satisfaction. Ensured all compliance was followed with SLA processes.

Coordinated production and quality control labour, while maintaining efficient document workflow deadlines.

Provide for the development and maintenance of document control systems to track product documentation throughout a product’s life cycle

Ensure appropriate systems are in place to track all facets of Document Control functions

Audit document releases to ensure accuracy and proper storage/archiving

Perform tasks related to Engineering Change Orders/auditing and host bi-weekly Change Control Board meetings.

Coordinate and communicate changes in document control functions and processes

Audit incoming documents to ensure consistency of form and accuracy of information

Performed migration and testing of Oracle Forms/Oracle Reports for the applications.

Developed audit operations metrics associated with assigned compounds to QA Management, clinical development staff and implemented corrective actions if required – implement ISO 13485 ComplianceSP.

Established and maintained measurements and metrics for on-time delivery.

Initiated and followed through on projects and initiatives that resulted in improved company report card and balanced scorecard performance – design, develop and maintain metrics requirements.

Met Federal Financial Regulations by developing and maintaining SOP documentation. Document Control supports the day-to-day operation of the Document Control function. Responsible for Quality Document and Record filing activities, off-site storage activities maintain off Site Company records. Customer Service activities/inquiries, document issuance, trouble-shooting issues pertaining to document requests and customer inquiries. Run various weekly/monthly metrics, reports and notifications.

Aon (Hewitt Associates) 2008 to 2010

Site Supervisor

Managed a team of 15 people for successful print operations and work flow job completion covering planning, scheduling, monitoring, quality control, final delivery and OSHA safety in an assigned team setting.

Monitored equipment and staff by recommending methods, procedures, organization, equipment and/or personnel to make the best use of available resources.

Developed and implemented Quality Control systems plans, policies, procedures and work instructions while implementing revisions related to SOP and Company Training Manuals.

Kept Management involved on general conditions and important matters like cost and deadlines

Maintained job reconciliation analysis for final invoicing to insure accurate billing.

Analysed daily inventory goods in Oracle system & made purchasing decisions based on business policy, customer MRO needs and supplier strategy.

Ricoh (IKON Office Solutions) 2001 to 2008

Site Supervisor – Cardinal Health

Managed a team of 8 people and acted as a liaison between four different departments.

Primary responsibilities included; ensuring smooth printing operations and 100% customer satisfaction and 100% quality perfection. Assist all internal and external Clients in timely and satisfactory manner.

Created analysis tools to help identify the best performance trends. Analyzed job estimates versus actual costs for implementation of process/budget improvement. Created, review, maintain and follow SOP.

Acted as a technical resource to the printing department personnel to address and resolve inquires, maintenance requests and problems related to assigned functions.

Applied product development life-cycle, including requirements analysis, specification, build, QA, documentation, training, and implementation into a production environment.

Reviewed and approved FDA printing process for local Fortune 50 Pharmaceutical Company utilizing GMP procedures to issue/audit/modify confidential documents.

Quality perfection achieved by applying Six Sigma and LEAN Specifications. Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements. Comply with applicable FDA and international regulatory laws/standards and the Client Code.

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