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Top 50 Senior Specialist Quality Assurance Skills

Below we've compiled a list of the most important skills for a Senior Specialist Quality Assurance. We ranked the top skills based on the percentage of Senior Specialist Quality Assurance resumes they appeared on. For example, 15.7% of Senior Specialist Quality Assurance resumes contained Ensure Compliance as a skill. Let's find out what skills a Senior Specialist Quality Assurance actually needs in order to be successful in the workplace.

These are the most important skills for a Senior Specialist Quality Assurance:

1. Ensure Compliance

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high Demand
Here's how Ensure Compliance is used in Senior Specialist Quality Assurance jobs:
  • Supported laboratory investigation process to ensure compliance with internal processes and FDA requirements and proposed CAPA strategies.
  • Coordinate documentation activities and implement documentation systems to ensure compliance with regulatory agencies and sponsor requirements.
  • Conducted vendor audits to ensure compliance with Federal regulations and standard operating procedures.
  • Performed audits of Manufacturing areas to ensure compliance to regulatory agency regulations.
  • Supported aspects of quality management governed by controlled documents to ensure compliance to regulatory agency (EMEA, APHIS) requirements.
  • Perform on-site and system audits within the Technical Operations Division to ensure compliance with approved policies, procedures and FAR requirements.
  • Develop programs for continuous improvement of EMS to accommodate ever changing Federal, State, and Local regulations to ensure compliance.
  • Conducted internal audits of all manufacturing departments at 45 and 51 New York Avenue to ensure compliance with current GMP.
  • Conducted annual compliance reviews of residential and vocational contract agencies to ensure compliance with state rules and statutes.
  • Conduct weekly, monthly, and quarterly audits to ensure compliance to Quality System (QS) regulations.
  • Perform internal audits of laboratory and support services to ensure compliance with published procedures and GMP regulations.
  • Manage Quality System activities and monitors the health of the systems to ensure compliance and improvement.
  • Interacted with manufacturing departments to ensure compliance with current GMP and industry standards.
  • Perform audits of substantial contract agencies to ensure compliance with current procedures.
  • Monitor production floor to ensure compliance with GMP and customer specifications.
  • Communicated file needs to upper management and providers to ensure compliance.
  • Interfaced with all divisional departments, marketing, R&D, and production to ensure compliance with standards and requirements.
  • Key Tasks Gather data by reviewing a specific established baseline to ensure compliance with governance, policies and procedures.
  • Reviewed, modified and approved SOPs / IQ / OQ / PQ protocols to ensure compliance.
  • Reviewed supplier files to ensure compliance to new revision of SOP Added and/or updated Approved Supplier List

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5 Ensure Compliance Jobs

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2. Test Cases

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high Demand
Here's how Test Cases is used in Senior Specialist Quality Assurance jobs:
  • Executed test cases on new and enhanced functionality; accurately document outcomes and issues with the use of HP Quality Center.
  • Utilize extensive quality assurance skills to develop, modify and execute software test plans, including data-specific test cases.
  • Worked extensively with Quality Center for requirements, Preparing Test cases, Executing, Defect openings and closings.
  • Prepared detailed test plan, test scripts and test cases by understanding the business logic and user requirements.
  • Understand the current production, write test plan and test cases, and manage the documentation.
  • Involved in writing Test plans, Test cases and responsible for executing the Test Scripts.
  • Created Test Plan, Test Scenarios, and Test Cases for all the quarterly releases.
  • Create, execute test cases, test scripts to ensure the production release works properly.
  • Involved in development of manual test cases and test scripts, based on requirements.
  • Maintained requirements, Test plans, Test cases and defects in Test Director.
  • Stored all the test cases and other testing related documents in Test Director.
  • Involved in writing test plans, test cases for several IVR applications.
  • Involved in preparing Test Plans, test cases and test conditions.
  • Executed test cases manually to verify actual results against expected results.
  • Created and implemented test cases in accordance with requirements.
  • Created, edited, and executed test cases.
  • Develop and execute test cases.
  • Executed test cases on Amdocs Enabler U-Verse application from customer creation to billing.
  • Develop scripts with Cyara Platform to automate majority of the regression test cases.
  • Tested different components of Deliverables management, Change management, deliverables discrepancy and develop test cases accordingly in Test Manager.

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4 Test Cases Jobs

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3. Audit Procedures

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high Demand
Here's how Audit Procedures is used in Senior Specialist Quality Assurance jobs:
  • Ensured entries are audited timely and accurately according to audit procedures.
  • Prepared document for internal audit procedures as a QA specialist.
  • Evaluate and enhance audit procedures to ensure compliance with cGMPs /Regulatory requirements and company policies.

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4. Product Quality

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high Demand
Here's how Product Quality is used in Senior Specialist Quality Assurance jobs:
  • Work closely with Operations Management to identify and implement strategies to reduce consumer complaints and improve product Quality.
  • Assessed product quality and integrity at retail outlets and customers finished product warehouses.
  • Improved product quality by ensuring software met or exceeded customer expectations.
  • Provided provision of Quality/Technical agreements and Annual Product Quality Reviews.
  • Selected member of the Product Quality Improvement team, responsible for 2nd shift follow-ups with Paint and Test Department problems.
  • Assist with preparation and report of Product Quality Review for commercial and proprietary products.
  • Worked with staff and clients to increase product quality and turnover by 35%.
  • Ensured product quality to guarantee compliance with quality policies, procedures and systems.
  • Compiled change control portion of Annual Product Quality Review.
  • Initiated and maintained Drug Master Files, Product Quality Reviews, QA release specifications, and COAs.
  • Led implementation of combination product Quality System by drafting, revising, and maintaining SOPs.
  • based on specific circumstances that could affect product quality.
  • Proposed, planed and established systems and procedures to ensure product quality and compliance with GCPs and GMPs requirements.

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3 Product Quality Jobs

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5. Capa

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high Demand
Here's how Capa is used in Senior Specialist Quality Assurance jobs:
  • Administered all raw material and finished product specifications including process capability analysis collaborating with multiple departments on final specification approval.
  • Updated and improved process to increase capacity and incorporate complaint handling of additional products.
  • Reduced Manufacturing Accountable Deviations by instituting meaningful and aggressive CAPA.
  • Developed/implemented self-audit programs, including sharing findings and determining CAPA.
  • Established process capability requirements based on manufacturing engineering standards.
  • Perform root cause analysis/implement CAPA for quality-related concerns.
  • Led internal audits across departments, documented findings, managed Corrective Action (CAPA) efforts, and implemented process improvements.
  • Reviewed, audited and approved Investigations and CAPA's (corrective actions and preventive actions).
  • Compiled, analyzed and reported on CAPA metrics and performed CAPA trending.
  • Review and approve CAPA's from laboratory.
  • Managed CAPA tracking and reporting using TrackWise.
  • Performed and reviewed investigations and CAPA.
  • Managed FDA drug annual review, customer complaint/CAPA database & safety incident reporting programs for our regulated products (i.e.
  • Review and assure that the Non-conformance Root Cause Analysis and identified CAPAs shall be granted prior final approval.
  • Opened product deviations, and CaPa's Tracking, auditing, organizing and filing batch records.
  • Perform root Cause Analysis Perform tracking and trending of CAPA's.
  • Managed SOP and CAPA Oversight Committees (SOG; COG) (e.g.
  • Eliminated Change Control backlog of over 200 records which included CAPAs, Discrepancy Reports and Engineering Change Notices.
  • Approved quality records such as nonconformance, CAPAs, change controls and validation documents.
  • Performed review and closure of Deviations, Investigations and CAPAs in Trackwise System.

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11 Capa Jobs

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6. Batch Records

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high Demand
Here's how Batch Records is used in Senior Specialist Quality Assurance jobs:
  • Reviewed and approved batch records executed by manufacturing.
  • Reviewed and approved batch records and supporting documentation.
  • Reviewed batch records and performed product conformance inspections.
  • Inspected and released biopsies received from clinical site to initiate production, including lot number assignment and issuance of batch records.
  • Perform the daily activities associated with receiving, logging and tracking incoming quality system change control requests and batch records.
  • Review and approve validation, method qualification, stability reports as well as manufacturing batch records.
  • Reviewed batch records executed by contract manufacturer on master cell culture for Phase I clinical trials.
  • Linked Change Controls, Process Events, and Deviations to Batch Records using SAP.
  • Reviewed in-house executed batch records prior to product release for Phase 1 clinical use.
  • Completed back log review of batch records for remediation in expected time frame.
  • Provide VA with batch records via electronic system with approved doctors E-signatures.
  • Review and approve batch records, raw materials and component test results.
  • Performed compliance review of batch records/formulation records and QC raw data.
  • Reviewed, approved and released batch records for third party contractors.
  • Issue and release batch records and make quality based decisions.
  • Review manufacturing batch records to approve products for release.
  • Review and approve post production batch records.
  • Review batch records for pilot batches.
  • Reviewed the batch records for investigations.
  • Reviewed batch records and stability reports for pre-clinical and Phase I drug products Established training matrix in electronic Learning Management System

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7 Batch Records Jobs

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7. FDA

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high Demand
Here's how FDA is used in Senior Specialist Quality Assurance jobs:
  • Provided guidance on FDA expectations/regulations and final approval of all GAMP validation life cycle documentation within the Quality Control unit.
  • Reviewed/revised internal and external audit procedures to confirm ongoing compliance with FDA regulations.
  • Developed new and modified existing operating procedures to meet updated FDA requirements.
  • Worked with the Inspection Management Team to resolve issues from the previous FDA inspections to ensure the standards are met.
  • Trained all categories in the US Technology Center on FDA regulations, GMP best practices, and quality systems.
  • Represent the site during multiple regulatory inspections including FDA, EU, Health Canada, and partner audits.
  • Lead internal audits of large Medical Device manufacturer for compliance to FDA, ISO and Canadian regulations.
  • Conducted investigations and generated status reports for FDA 483 observations and internal audits related to training issues.
  • Provided and implemented all inter-active training of safety practices required by OSHA and the FDA.
  • Provide QAPC Manufacturing Business Unit Support as needed in preparation and during FDA inspections.
  • Supported FDA Consent Decree as the QA leader for the cleaning validation remediation project.
  • Audit support operations to assess compliance with FDA GLP regulations and industry standards.
  • Hired to help resolve compliance concerns identified in an FDA Warning Letter.
  • Presented records during Regulatory Agencies Inspections (FDA, EU).
  • Led three consecutive, successful FDA inspection with zero findings.
  • Perform FDA audits, database work and implement new batch records
  • Assisted in preparations for mock and actual FDA audits.
  • Support preparation for external audits by the FDA.
  • Contributed to the successful 0-483 observations in 4th-quarter 2013 FDA pre-approval inspection.
  • Ensured that approval of all batches meets AstraZeneca SOPs, cGMPs and FDA Regulations.

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7 FDA Jobs

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8. Validation Protocols

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high Demand
Here's how Validation Protocols is used in Senior Specialist Quality Assurance jobs:
  • Review procedures, validation protocols, investigations and corrective/preventative actions primarily for Microbiology laboratories and Stability Services.
  • Reviewed validation protocols and final reports for cleaning, processing and packaging activities.
  • Reviewed validation protocols for Clinical Oracle.
  • Investigate and correct CAPA findings, IQ/OQ/PQ validation protocols for internal audits and Out of Specification (OOS) test results.
  • Review and approval of specifications, standard operating procedures, validation protocols/reports, investigations, CAPA's and change controls.
  • Assisted in reviewing validation protocols that included Oracle software used for clinical trials prior to Director's approval.
  • Developed validation protocols; supervised the execution of protocols in compliance with 21 CFR Part 11.
  • Reviewed standard operating procedures, validation protocols/reports, Work Orders and Job Plans.
  • Reviewed and edited as necessary the process and method validation protocols and reports.
  • Reviewed documentation for compliance, including SOPs, requirement and design specifications, validation protocols, and validation summaries.
  • Review laboratory and manufacturing validation protocols / reports to ensure compliance with company policies.
  • Reviewed and analyzed validation protocols (IQs, OQs, and PQs) from multiple sites.
  • work orders, validation protocols, SOP's, and Product Complaint System).

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2 Validation Protocols Jobs

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9. Corrective Action

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high Demand
Here's how Corrective Action is used in Senior Specialist Quality Assurance jobs:
  • Provided weekly figures from the Quality Referral Database; which included identifying repetitive errors and taking corrective action.
  • Collaborate with leadership and programmers to develop corrective actions in response to internal auditors and external regulatory inspectors.
  • Advise responsible officials concerning the quality of products, establishing or revising methodologies/procedures, and effecting corrective actions.
  • Coordinated with compliance, legal and operations groups regarding appropriate resolutions and/or corrective actions.
  • Initiate and perform investigations and coordinate corrective actions for non-conforming GMP materials.
  • Root cause analysis and implementation of corrective action for process related concerns.
  • Conducted audits, documented findings and corrective action recommendations, if necessary.
  • Assist departments in corrective actions and quality improvement initiatives.
  • Developed recommendations and corrective actions to rectify deficiencies.
  • Reported and approved corrective actions.
  • Assisted/managed lab self audits and manage findings/corrective actions with an eye toward improvement and a systems approach.
  • Participate in Quality investigations utilizing QA tools and follows up on corrective actions to closeout.
  • Prepare reports of deficiencies and non-compliance and to ensure timely and appropriate corrective action.
  • Supported, audited and followed up on corrective actions of NCH contractors.
  • Provided staff with guidance and implemented corrective action plans as appropriate.
  • Evaluate deviation to ensure assignable causes and corrective actions are appropriate.
  • Authored the deviation; implemented corrective action.
  • Evaluated non-conformances and assessed quality impact, recommended corrective actions and followed up to ensure corrective actions implemented were effective.
  • Ensured supplier Corrective Action Requests (CARs) are being properly issued and closed.
  • Performed cross functional audits, risk assessments and initiated corrective actions ensuring compliance with cGMPs, applicable SOPs and guidelines.

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3 Corrective Action Jobs

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10. GMP

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high Demand
Here's how GMP is used in Senior Specialist Quality Assurance jobs:
  • Developed databases to support the tracking of various GMP manufacturing associated activities.
  • Delivered Good Documentation Practices to new hires; developed the 2016 GMP refresher CBT in Captivate.
  • Approve Calibration Reports and HEPA filter certifications related to GMP operations.
  • Developed the OJT (On the Job Training) for the GMP department.
  • Performed the review and approval of raw material and product documentation to ensure compliance with cGMP and AstraZeneca procedures and policies.
  • Based on review of appropriate documentation, formally release processing equipment and processing rooms for use in cGMP manufacturing.
  • Review, prepare and/or approve all GMP documentation including SOPs, Batch Records, Bill of Materials, etc.
  • Assisted with development of cGMP and QA training materials and provided company-wide training on compliance related issues and procedures.
  • Draft, review and oversee quality investigations, manufacturing deviations, cGMP issues, and non-conforming materials.
  • Provided aid in development of master batch records with new contractors to ensure they meet GMP requirements.
  • Provided training for new peers and coworkers on cGMPs, batch record review and company procedures.
  • Monitored Newark site's packaging line operations to ensure that cGMPs and SOP's were followed.
  • Provided quality assurance support within a cGMP commercial API facility.
  • Performed internal and external audits to ensure cGMP compliance.
  • Performed routine walk-through audits in cGMP manufacturing areas.
  • Conducted audits and GMP walkthroughs.
  • Manage timely review of documents and support data to assure completeness, traceability, accuracy and compliance to cGMP requirements.
  • Inspect and release raw materials, components, labels and finished products per cGMP and company SOPs.
  • Provide Quality Assurance support for Phase I/II cGMP manufacturing of bulk biologics as well as Fill/Finish activities.
  • Authored and reviewed SOPs in accordance with cGMPs, government regulations, and corporate policies.

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16 GMP Jobs

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11. Process Improvement

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high Demand
Here's how Process Improvement is used in Senior Specialist Quality Assurance jobs:
  • Participated in process improvement projects and provided feedback on cost effective ways to improve company performance.
  • Provided recommendations and feedback to the contact center associates for process improvements.
  • Worked toward establishment of an Engineering Process Group to facilitate process improvement.
  • Facilitate and participate in peer reviews of process improvements and/or documentation.
  • Team leadership, mentoring, business process improvement and project documentation.
  • Provided quality support for six-sigma and other process improvement projects.
  • Participated in process improvement and completed relative documents when required.
  • Conducted annual review of existing procedures providing process improvement recommendations.
  • Aligned quality process improvements with critical business needs.
  • Managed of a team of five to improve key metrics by decreasing human error during the booking process through process improvements.
  • Managed projects across multiple customers and ranging from internal process improvement to SLA agreements with clients (health plans).
  • Developed quality assurance process improvement, test strategy, test plan and test cases for financial and business application.
  • Provided coaching and training to employees, track completed monitors and produced ideas for process improvement.
  • Trained Green-Belt to manage Lean Six Sigma projects to drive regulatory and quality process improvement.
  • Chair of process improvement meetings contributing to the continuous improvement of company goals.
  • Interpret auditing data and analyze data for training, process improvement and trends.
  • Managed Lean Six Sigma projects to drive RA/QA process improvement.
  • Assured compliance at all NCH contract facilities with product/process improvements.
  • Authored and revised SOPs for process improvement.
  • Support Nonconformance/Deviation, CAPA and Change Control programs for quality and process improvement initiatives.

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12. Pl/Sql

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high Demand
Here's how Pl/Sql is used in Senior Specialist Quality Assurance jobs:
  • Created PL/SQL Plus scripts to generate training labs and manipulate Oracle and MS-SQL Server database table data.
  • Conducted PL/SQL and IV&V training classes for the QA/CM team.
  • Worked on SQL and PL/SQL and performed backend validations.

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13. Raw Materials

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high Demand
Here's how Raw Materials is used in Senior Specialist Quality Assurance jobs:
  • Aided in development of specification criteria for finished product and raw materials.
  • Performed qualitative and quantitative chemical analysis of raw materials.
  • Review and release incoming raw materials used in the fabrication of lenses for clinical trials and design control activities.
  • Assured raw materials and drug product followed FIFO and were stored and managed to meet all product specifications.
  • Performed batch record reviews, responsible for lot release of components of kits and raw materials.
  • Created and implemented a database for tracking raw materials and release of clinical supplies.
  • Spearheaded site-wide four-month project to eliminate 1-year backlog of raw materials to be sampled.
  • Manage release of finished product, raw materials, printed components and devices.
  • Released raw materials, plasma pools, critical intermediates, formulated bulks.
  • Assign Material ID numbers for raw materials, in-process and finished products.
  • Inspect, review, approved and disposition raw materials.
  • Release of raw materials and packaging components.
  • Developed methods for microbial limits and endotoxin testing of raw materials.
  • Participated in kaizen blitz of the raw material storage warehouse, streamlining availability of raw materials for production use.

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14. Management System

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high Demand
Here's how Management System is used in Senior Specialist Quality Assurance jobs:
  • Participated in vendor audits and review, specifically for IT service management system solution providers.
  • Verify emails' technical setup in a proprietary content management system.
  • Develop and administer a centralized document management system.
  • Tested CLS (a hotel property management system) software enhancements and LodgingTouch, a Windows-based client/server PMS software.
  • Provide guidance and support to site QA and business partners in the development and use of documentation management systems.
  • Reviewed and approved all Building Management System alarm logs, work orders, facility logbooks and annual HVAC reports.
  • Maintained the Quality Management System for marketed products, including GMP audit program for suppliers, contractors and affiliates.
  • Supervised North American Fine Chemicals QA Plant Group, one report, and directed Corporate Non-Conformance Management system.
  • Tested software used in financial applications such as stock trading, portfolio management and client investment management systems.
  • Tested a web-based error management system and also tested in a UNIX/SunSolaris/Oracle 8.05 environment, utilizing SQLPLUS.
  • Support VMS (Visual Management Systems) project for continuous improvement and harmonization project between two sites.
  • Assisted in the creation and development of the company's customer relationship management system.
  • Maintain SQL Server Load applications for the Financial Management System (FMS).
  • Managed a team of two direct reports in support of Quality Management Systems.
  • Team leader for Electronic Document Management Systems (EDMS) project implementation.
  • Established, implemented and improved Quality Management System for GMP.
  • Implemented a Quality Management System for PLM+.
  • Developed and maintained Biosynexus' Document Management System and Vendor Qualification and Agreement program.
  • Migrate company documents, BOMs, drawings from the QMS (Quality Management system) into Agile Database 9.3.
  • Program Manager of third party certified ISO 14001 program for Con Ed's Environmental Management System (EMS).

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6 Management System Jobs

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15. Customer Service

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Here's how Customer Service is used in Senior Specialist Quality Assurance jobs:
  • Provided continuous feedback to management on all quality assurance and customer service issues.
  • Maintained quality control/satisfaction records, brainstormed new ways to improve customer service.
  • Top performer in the customer services division for productivity
  • Serviced customer service calls for external customers.
  • Key Achievements: Pioneer Quality Assurance Specialist for PHH Mortgage Customer Service and served as an OIC for the Quality Department.
  • Performed associate level quality assurance reviews on departments such as Customer Service, Loss Mitigation, Short Sale and Bankruptcy.
  • Assisted in processing Verizon sales orders among team members as well as other departments to achieve outstanding customer service.
  • Perform customer service quality observations with focus on the customer experience for the cellular and local divisions.
  • Trouble shoot and resolve customer service issues on a daily basis (via telephone and in-person).
  • Adhered to the goal of delivering and maintaining the highest quality of customer service to clients.
  • Coach and counsel Customer Service agents, influencing them to take action and achieve objectives.
  • Provide customer service support with any questions or issues that may arise.
  • Second level support for Technical Support and Customer Service.
  • Monitor inbound Customer Service phone calls.
  • Provide exceptional client and customer service.
  • Provide efficient customer service to clients.
  • Assist in resolving customer service issues.
  • Provide excellent customer service to develop relationships with customers by completing tasks in a timely manner.
  • Job Responsibilities: Monitored and graded the calls received by Customer Service Representatives.
  • Provided excellent and timely customer service, including answering our advisors questions and resolving issues within the underwriting of a case.

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16. QA

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Here's how QA is used in Senior Specialist Quality Assurance jobs:
  • Provided QA support for Manufacturing and Quality Control operations in a lean manufacturing environment.
  • Provided Cleaning Validation Seminar to Manufacturing and QA team members.
  • Tracked trends to identify possible compliance issues and presented the trends in divisional QA and branch sales manager meetings.
  • Provided testing and QA support to the U.S. Census Bureau Headquarters, re: Regional Office and PowerBuilder applications.
  • Recommended and performed changes to QA SOP's as they pertained to release functions.
  • Led and managed the QA review of 77+ branches in the Western Region.
  • Test Effectiveness Metrics and Gap analysis on the Production and QA Issues.
  • Assisted in continuous improvements opportunities to streamline QA processes in LEAN environment.
  • Generate, review and complete non compliance reports and QA investigations.
  • Represented QAPC department on the new product and the extension launches.
  • Involved in Technical Transfer as the QA Representative for Merck.
  • Perform Content QA checks on SMS and Email applications.
  • Perform QA checks on voice/speech applications branch testing.
  • Perform QA audits on processes and/or documentation.
  • Authorized as QA signature on SOPS, COAS, and CRFS.
  • Developed and maintained QA work plan for all QA activities on the team and provided input for quality issues/questions that arise.
  • Supported the approval process within Quality Assurance Product Certification (QAPC) relating to product quality and deviations.
  • Created and updated QAPC (Quality Assurance Product Certification) SOPs and performance standards.
  • Led a CSV QA SOP global harmonization team, two Yellow Belt teams, and managed a Hoshin Kanri A3.
  • Reviewed documentation for "stop shipments" of products released by contractor QA.

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21 QA Jobs

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17. QC

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Here's how QC is used in Senior Specialist Quality Assurance jobs:
  • Supervised 5-12 QC Inspectors responsible for performing activities associated with product certification
  • Provided new QC representatives with deployment rules and guidelines
  • Create and order Quality Forms, Quality Configuration Stamps, SPC and PQC badges for the production certified team members.
  • Develop, evaluate (trends), submit and present QC Laboratories metrics to Quality Control and Site Management.
  • Supported and provide quality decisions to various functional areas including Regulatory, QC, IT, Manufacturing, Facilities.
  • Provided compliance support and guidance to QA, Validation, QC, Manufacturing, Engineering, and IT.
  • Documented Test Scenarios, Test cases in excel sheet and imported them to HP ALM/QC through Export Wizard.
  • Developed QC program and managed a team of three to successfully complete two projects a month.
  • Develop sampling inspection plans using ANSI/ASQC Z-1.4 and provide work order instructions for rework colleagues.
  • Organize certified teams for Production Quality Control Member (PQCM) on Team Concept.
  • Implemented QC 10.0 for Department, build work flow between teams and create training.
  • Contributed to the design and staffing of a new Microbiology QC lab.
  • Coordinated QC test plan and defect tracking list migration from legacy sources.
  • Reviewed QC test results for drug substance/product by accessing LIMS system.
  • Represented Quality Assurance - IQC on USA and Global Launch teams.
  • Set up reagent QC and instrument QC procedures and documentation system
  • Assure that the company is in compliance with QA/QC standards.
  • Review of GMP QC analytical documentation, such as methods, specifications, stability study reports, method transfer reports.
  • Created and updated IQC (Incoming Quality Control) SOPs (Standard Operating Procedures).
  • Develop and manage CAPAs for implementation and compliance within QCBD.

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8 QC Jobs

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18. ISO

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Here's how ISO is used in Senior Specialist Quality Assurance jobs:
  • Established and maintained cooperative working relationships with company personnel, supervisors, and physician office personnel.
  • Assisted the Laboratory Supervisor in writing laboratory investigations and determining root cause.
  • Trained newly promoted Technical Support Supervisors on Quality performance metrics.
  • Served as liaison for client audits, FDA, DEA, FL Dept of Health and performed external audits of suppliers.
  • Maintain good communication with the quality supervisors, peers, and the manufacturing and service departments' personnel
  • Assisted QA Manager in preparation for, and during conduction of, API and ISO audits.
  • Worked closely with software developers to define test requirements and describe and isolate software defects.
  • Organized and facilitated sponsor and third party ISO audits: identified and implemented CAPA's.
  • Served as an advisory member of the PLM+ Configuration Control Board (CCB).
  • Played an integral role in the process improvement efforts associated with ISO 9001:2000 certification.
  • Lead auditor in support of quality management system ISO 9001 and TS16949 certification.
  • Documented current QA processes and created/updated corporate templates to new ISO standards.
  • Performed Head of Quality responsibility implementing QSR ISO and FDA regulations.
  • Performed gap analysis of current processes to ISO 9001:2000 standards.
  • Lead liaison between the GLC and designated software vendors.
  • Provide mentoring to the QA Supervisory staff as required.
  • Serve as the Company Liaison during Customer Audits.
  • Support external audits such as FDA and ISO.
  • Participated on ISO-9002 Quality System steering committee.
  • Collaborated with supervisors for performance enhancements of least performing personnel.

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2 ISO Jobs

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19. User Acceptance

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Here's how User Acceptance is used in Senior Specialist Quality Assurance jobs:
  • Participated in User Acceptance Testing and production implementation with technical support.
  • Directed claims system quality assurance and user acceptance testing.
  • Analyzed new software development and user acceptance testing.
  • Participated in user acceptance testing support as needed.
  • Assisted in User Acceptance Testing (UAT), maintaining quality procedures and ensuring that the appropriate document is in place.
  • Developed and execute comprehensive test plans for new and existing functions for system, regression and user acceptance test phases.
  • Facilitated the management of client expectations as well as provided end-to-end support throughout the client user acceptance testing period.
  • Performed User Acceptance Testing in the final phase of software development process to check the functionality of the software.
  • Tested system security, disaster recovery process, section 508 compliance and User Acceptance Test (UAT).
  • Organized and coordinated multiple User Acceptance (UAT) testing efforts for my own and other co-workers projects.
  • Executed the role of Business Analyst during User Acceptance Testing of the company's largest product.
  • Perform auditing of Functional, Regression, User Acceptance, integration and Performance testing.
  • Participated in security testing and User Acceptance Testing (UAT) using Test Manager.
  • Supported and tested usability from the initial design stages through user acceptance.
  • Participated and led in user acceptance testing.

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20. Project Management

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Here's how Project Management is used in Senior Specialist Quality Assurance jobs:
  • Participated actively in weekly status meeting and communicated status to project management team and stakeholders.
  • Project management to develop, implement and maintain internal quality systems and procedures.
  • Conducted product acceptance testing for all major releases and custom projects as directed by product and project management.
  • Received client awards and recognition for performance in the areas of systems testing and project management.
  • Supported the quality system as a system administrator and a project management for the quality projects.
  • Presented the QA presentations to Project Management and other teams on behalf of QA team.
  • Provided leadership and project management for a 1500 employee division of Federal Express.
  • Project management to include company partnerships, in a QA lead capacity.
  • Provided metrics on testing progress to QA and project management.
  • Collaborate with other AHMSI sites for project management duties.
  • Reviewed and recommended changes/clarification during the development and renegotiation of the DuPont 2006 Contract for Project Management and billable/nonbillable activity.
  • Key Achievements: Led a team of five testers and project managements during a number of test cycles.

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21. Business Requirements

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Here's how Business Requirements is used in Senior Specialist Quality Assurance jobs:
  • Facilitated Joint Application design (JAD) sessions to organize and understand Business Requirements and Functional Specifications.
  • Create Test Cases for all system modifications and enhancements based on approved Business Requirements.
  • Trained QA testing team in deciphering systems technical specifications to write Business Requirements.
  • Analyzed business requirements and system architecture/design.
  • Performed Unit testing, System Integration Testing, User Acceptance Testing and Regression testing as per the Business Requirements.
  • Acted as a key interface with clients to determine business requirements and set expectations for current and upcoming projects.
  • Develop test plans, reports, and cases from detailed test strategies, business requirements and functional designs.
  • Gathered business requirements, defined scope, and managed progress with stakeholders and decision makers.
  • Interacted with business heads to finalize the business requirements for the application.
  • Provided feedback on Business Requirements, Technical Requirements, and Test Plans.
  • Create and execute test cases to ensure business requirements are exceeded.
  • Attend design calls, understand business requirements and prepare test scenarios/cases.
  • Prepared the design of software test plans to verify business requirements.
  • Created & maintained automated regression test scripts from business requirements & specifications using Seapine's QA Wizard Pro.

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22. UAT

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Here's how UAT is used in Senior Specialist Quality Assurance jobs:
  • Implement principles of performance evaluation and prediction methods used to improve product systems safety, reliability, and maintainability.
  • Spearheaded project to evaluate expiration dates for all 350 incoming materials, utilizing vendor expiration dating recommendations.
  • Evaluated systemic importance of deficiencies including questioned costs and possible revisions to current policies and procedures.
  • Interfaced with business and technical units to analyze data and situations leading to sound decision-making.
  • Evaluate reported in - process manufacturing data for compliance with appropriate specifications.
  • Referred situations to Quality Manager gathered during Master Data auditing activities.
  • Evaluated and analyzed data during process / assembly operation.
  • Conduct ongoing objective evaluations of operations and controls.
  • Supported the UAT test effort at the Memphis Merry Maids branch; This included training less experienced testers and new users.
  • Processed and evaluated complaints, grievances and appeals to determine the validity and forwarded to other agencies with higher authority.
  • Attended weekly calibration sessions with the client and checked the consistency of grading and evaluation of calls.
  • Evaluated the impact of deviations to determine corrective actions and the final disposition of those materials.
  • Provided technical support and assistance to assure R6 Project implementation plan is adequate.
  • Evaluate Test Phase Entry and Exit Criteria and Readiness for UAT and OAT.
  • Performed functionality testing and evaluation on new products' designs.
  • Evaluate records for prevention and retention.
  • Compressed Air Evaluated the Change Control for DEA approval for the Validation (equipment and utilities).
  • Involved in the nesting process through call evaluation, providing feedback and conducting Quality process trainings.
  • Evaluated the testing tool and created the automate test scripts in Visual Basic.
  • Review of Manufacturing and Packaging Batch Records Review and Evaluate of Operational/Analytical Deviations/Investigations from Production, Facility and Analytical.

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23. Trackwise

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Here's how Trackwise is used in Senior Specialist Quality Assurance jobs:
  • Supported Aseptic Filling Operations by reviewing and granting final approval of Manufacturing Deviation Investigations in TrackWise.
  • Provided training and support in use of TrackWise software domestically and to overseas resources.
  • Trained and supported plant personnel in Change Control Program using TrackWise and SAP.
  • Initiated and tracked deviations in the TrackWise database.
  • Subject Matter Expert on the CAPA Process as well as the use of TrackWise and SAP-CAPA.
  • Supported the migration of Argus system to Trackwise Harmony system project including requirements gathering and documentation reviews.
  • Managed Third Party contract manufacturer, packager, and supplier deviations and investigations in Trackwise.
  • Supported to Change Control end users providing training in Trackwise and SAP systems.
  • Initiated and reviewed deviations, investigations and CAPA's using Trackwise.
  • Trained in Peoplesoft, TrackWise, AQWA and QILS Management programs.
  • Review and close events/discrepancies within the Trackwise database.
  • Managed and facilitated the Trackwise Change Request Program/Non Conformances using root cause analysis.
  • Sole Trackwise Developer for bulk drug substance manufacting site and drug testing center in the UK.
  • Work with Validation team to expedite outstanding PRs; perform periodic review of overdue PRs all using GTrack (TrackWise).
  • Managed deviation investigations, CAPAs and Complaints in Trackwise pertaining to their timelines.

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24. CFR

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Here's how CFR is used in Senior Specialist Quality Assurance jobs:
  • Created SOP and related documentation templates for system to evaluate equipment and instrumentation for compliance under 21 CFR Part 11.
  • Conducted monthly internal audits to 21 CFR 211 standards, reporting observations to department manager and QA management.
  • Ensured that diverse technology components included 21CFR Part 11, 21 CFR Parts 210, 211 functionality.
  • Developed, validated and maintained quality assurance database in compliance with 21 CFR Part 11.
  • Implemented and maintained a quality system based on CFR (Code of Federal Regulation).
  • Assisted in GMP training presentation covering 21 CFR Parts 210 and 211.
  • Followed 9CFR and USDA regulations.
  • Conducted GDP, CSV, GVP, and 21 CFR Part 11 training sessions.

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25. SQL

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Here's how SQL is used in Senior Specialist Quality Assurance jobs:
  • Analyze, test documentation design, and performed functionality testing for internal SQL based Consumer Reference Database.
  • Saved time in the testing phase, by creating test starter data and writing SQL scripts in the design phase.
  • Worked closely with Developers on optimizing and debugging SQL scripts to ensure performance and accuracy of data returned.
  • Performed the Back-End integration testing to ensure data consistency on front-end by writing and executing SQL statements.
  • Perform critical testing on the applications/program configurations using T-SQL, stored procedures and some SSIS packages.
  • Performed back-end testing using SQL queries to validate user interface values against database for Integration testing.
  • Trained and mentored testers on regression testing, dirty testing and creation of SQL.
  • Use Microsoft SQL Server to perform environment setup and backup of current builds.
  • Experience in writing SQL queries to extract data from SQL Developer and TOAD.
  • Used SQL queries and executed stored procedures as part of testing.
  • Tested SQL Server Integration Services (SSIS) batch jobs.
  • Reviewed & executed SQL Server stored procedures and queries.
  • Applied T-SQL on stored procedures and DTS.
  • Installed and configured NT 4.0 server, SQL Server 7.0 and SQL 2000.
  • Tested front end user interface, website, backend application, and SQL tables and stores procedures.
  • Structured one-off and complete order flow automation via AutoIt3, SQLite, and Quick Test Professional.
  • Performed numerous SQL queries using SQL-Plus and DBSurfer to gather data and validate test results.
  • Performed End-to-End testing and backend testing using SQL queries.
  • Carried out backend Data validations using SQL queries.
  • Involved in writing SQL queries for Backend Testing to verify the Data Flow within the Frontend and backend.

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26. API

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Here's how API is used in Senior Specialist Quality Assurance jobs:
  • Designed, maintained and executed Automated Integration framework of API/Web Services across multiple test and production environments using SOA test.
  • Reconcile dividend, capital gain, interest, cash in lieu, and commission payments.
  • Test Data Management team will provide Test Data to various testing teams in Capital One.
  • Created data-driven automation scripts for testing API Web Services using SOAP UI.
  • Utilized Charles and Paw tools for REST API testing.
  • Run API/CMO Vendor Qualification and Quality Agreement program.
  • Experienced with API, ASTM, ASME, NACE, AWS, ASQ, BSI, and ISO.
  • Core exposes the REST APIs to initiate the test and get statuses and reports from current/previous tests.
  • Analyze and verify supplier data books meet Weatherford specifications and API 6A.
  • Process validation lead for custom large and small scale APIs.
  • Used the Build.Com for BDC API database testing.
  • Review and approve master and production batch records.Disposition final intermediates and APIs (includes review of all associated documentation).
  • Approve raw material specifications and C of A of excipients and API.

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27. Quality Standards

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Here's how Quality Standards is used in Senior Specialist Quality Assurance jobs:
  • Audit individual employee productivity on a daily basis to assure quality standards are met in accordance with departmental policy.
  • Provided USMC Government customers with matrices to establish software quality standards regarding current and future requirements.
  • Implemented Corporate Quality Standards related to packaging operations.
  • Established call monitoring system (Witness) to review random sampling of incoming calls to ensure quality standards are met
  • Reviewed and approved deviations to standard operating procedures, master formulas, quality standards and test methods.
  • Complied to the adherence of quality standards based on business guidelines relevant to set policies and procedures.
  • Developed the Quality Standards Program as part of the implementation of Key Quality Systems.
  • Assisted with the implementation of approved planning in accordance with quality standards.
  • Ensured project compliance with Corporate quality standards and CMMI.
  • Reviewed plans and procedures for compliance of quality standards.
  • Interpret and apply quality standards AS50881, MIL-Q-9858, MIL-1-45208 and AS9100.
  • Managed 1 full-time calibration technician and 2 temporary employees while ensuring all battery testing systems were maintained to highest quality standards.
  • Worked alongside various project teams to maintain and uphold high quality standards while ensuring strict timelines.
  • worked with cross company departments and staff to ensure quality standards /within organizations are met.
  • Completed audits to ensure Amica quality standards were being met.
  • Evaluated Pharmaceutical Sciences (PharmSci) SOPs for compliance against Pfizer Quality Standards (PQSs).

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28. R

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Here's how R is used in Senior Specialist Quality Assurance jobs:
  • Assist in insuring compliance with all safety and environmental requirements associated with the processing and laboratory activities.
  • Conduct reviews of Validation/Stability protocols for accuracy and completeness, documenting discrepancies/deviations ensuring appropriate closure.
  • Perform temperature, humidity and room pressurization reviews completing and filing appropriate documentation.
  • Generate multiple discipline surveillance checklists utilizing QAM and project job specific quality requirements.
  • Monitor QA/QC activities to determine conformance with corporate policy and procedures.
  • Recognized work and job performance lauded numerous company bonuses.
  • Review of Engineering Changes for impact to validation/calibration status.
  • Review /monitor QAM, Shop and project specific procedures for quality program effectiveness.
  • Review and disposition of clinical trial and commercial records as well as materials.
  • Worked closely with all internal departments to ensure correct service and billing.
  • Apply quality review process to factual summary of the ACA appeal.
  • Project: DART Phase II Build-Out Project Location: Dallas, Texas
  • Conduct internal compliance reviews and follow up of deviation issues.
  • Review company Standard Operating Procedures (SOP).
  • Report to Quality Manager and/or QA Manager.
  • Initiate, author and review Investigations.
  • Reported to QA Project Manager.
  • Support the development and implementation of Mercury R6 Project to prevent and eliminate non-compliances.
  • Provide oversight of Quality System applications (e.g.
  • Document identified non-conformances via CARs and Condition Reports.

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29. QTP

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Here's how QTP is used in Senior Specialist Quality Assurance jobs:
  • Implemented Reusable functional using QTP Framework
  • Created manual test by using Quality Center and automated test by using QTP * Designed and implemented the QA test strategies.
  • Executed Regression test by set up and execution of the QTP Scripts & sent test result summary to all team members.
  • Recorded and played test scripts using Quick Test Pro (QTP) for automation to perform functional and regression testing.
  • Used QTP for modifying and comparing data in Excel files and used for running Excel Macros in background.
  • Maintained QTP Regression Automation Test Scripts in the Test Director for ECRM/COP integration with IVR system.
  • Created and executed QTP test scripts suites for daily regression runs.
  • Automated test cases produced in QTP to assist with future regression.
  • Run automation scripts in QTP/UFT for regression and functional testing.
  • Experience in using Quality Center for maintaining QTP scripts.
  • Have worked on multiple Object Repositories in QTP.
  • Executed automated testing scripts with QTP.
  • Used QTP for running automation test.
  • Automated test scripts using QTP.
  • Enhanced regression test cases to implement complex testing scenarios, increased permeations of functionality testing and increased code coverage using QTP.
  • Upgraded the Oracle database for TestDirector Wrote QTP scripts for CCS, ESS & MSS modules
  • Use Mercury' suite of testing tools (QC, QTP).
  • Document framework models Create Selenium and Test Automation content for company blog Create lunch and learn sessions - QTP to Selenium

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30. SME

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low Demand
Here's how SME is used in Senior Specialist Quality Assurance jobs:
  • Perform Vendor Change Notification impact assessments for all business units by reviewing and evaluating vendor changes to components.
  • Led Opportunity Assessment Workshops that included detailed Value Stream Mapping to identify potential project opportunities.
  • Prepare for the audit/assessment activity by researching background information, including previous audit results.
  • Perform procurement document reviews; supplier qualifications; supplier assessments and source inspections.
  • Assisted in initiation and deviation closure by providing quality impact assessments.
  • Execute QA function on Westinghouse VC Summer ASME Section III / B31.1 piping components, sub-assemblies, and supports fabrication.
  • Managed Part 11 compliance system for site; conduct assessments, write reports and remediation plans.
  • Perform the audit / assessment by collecting and analyzing objective evidence regarding issues and risks.
  • Initiate Change Controls, perform impact assessments and review Change Control tasks for accuracy.
  • Customized monitoring and assessment criteria used to audit employees on a monthly basis.
  • Created performance objectives / manager review assessment and assisted QA Director.
  • Developed medical systems and treatment assessment tools throughout the agency.
  • Assist in planning and developing assessment strategy and logistics.
  • Maintain the assessment file through the process to closure.
  • Perform Test Risk Assessment for each Release.
  • Acted as a SME and trainer.
  • Reviewed and approved Process Performance Qualification GAP Assessment of previous process validations in accordance to remediated process validation SOP.
  • Served as functional tester and SME for System X, conducting pre- and post-release (Red Hat) testing.
  • Change Management / Change Control Investigations handling, CAPA, Risk Assessments, Complaint handling-Adverse Events / Other.
  • Provide QA assessment and approval of GXP computer systems related deviations, CAPAs and change controls.

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31. Customer Complaints

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Here's how Customer Complaints is used in Senior Specialist Quality Assurance jobs:
  • Handled and investigated customer complaints, subsequently recommending remediation for non- compliance and/or best practices handling.
  • Revised all documentation relating to customer complaints.
  • Assisted with clarifying instructions, customer complaints, corrective actions, quality assurance audits and product validations.
  • Follow up on external audits, action items and works with customer complaints from a product standpoint.
  • Supported QA group in investigation and resolution of customer complaints (CAPA)
  • Support of Internal and External Audits as well as customer complaints investigations.
  • Investigate, document and respond to customer complaints for adverse events.
  • Investigated, closed and tracked customer complaints.
  • Subject Matter Expert (SME) in Customer Complaints, Investigations, Deviations, CAPA's and OOS's.
  • Reviewed customer complaints and CAPAs to ensure they meet regulatory requirements and company procedures.
  • Reviewed cGMP investigations, QA Hold, planned deviations, and in excess number of customer complaints.

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32. Unix

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Here's how Unix is used in Senior Specialist Quality Assurance jobs:
  • Managed software testing teams in a Pyramid/Sun Unix environment to validate and document a personal computer based Human Resources application.
  • Mixed Linux/Unix environments required standard knowledge of each platform's unique behaviors.
  • Executed test cases on UNIX operating system.
  • Skilled with Oracle, SQL Server, SSIS packages, UNIX, IBM, VMWARE and Visual Basic.
  • Verified Auto sys UNIX jobs functionality as a part of release requirements and regression.

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33. Document Control

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Here's how Document Control is used in Senior Specialist Quality Assurance jobs:
  • Document Control System Specialist is also responsible for system administration, metrics reporting and the overall effectiveness on the system.
  • Train and provide guidance to personnel who serve in a document control backup role and/or provide support for the department.
  • Revise official document control forms as needed, and distribute documents to foundry and subcontractors.
  • Manage the document control process within the electronic document control system.
  • Track document control and archival metrics for the department.
  • Managed the document control and training functions.
  • Managed QA and Document Control departments.
  • Document Control Activities and Training.
  • Acted as Document Control Coordinator for Pilgrim SmartDoc, in order to create and revise SOPs and other controlled documents.
  • Direct daily operations of the Document Control Department, and ensure compliance of the corporate records database.

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34. Technical Support

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Here's how Technical Support is used in Senior Specialist Quality Assurance jobs:
  • Partnered with operations supervisors and technical support to increase customer satisfactions and improve staff tools through curriculum and document improvement.
  • Maintained the tracking and integrity of database containing veteran and client information and health statistics with additional technical support
  • Provided technical support to the manufacturing areas to assure thoroughness and completeness of investigations.
  • Provided technical support for 11 battery testing facilities globally.
  • Performed as principal technical support for customer inquiries/issues.
  • Supervised seasonal associates in the Technical Support area.
  • Provided technical support and consultancy for Crystal Reports, SQL Server Reporting Services, and Access database users.
  • Assisted technical support with troubleshooting customer problems as well as assisting beta customers with technical issues.
  • Assist Technical Support, Regulatory, and Operations with product transfers and special projects.
  • Provided Level II technical support to the users of a proprietary software.
  • Provided technical support and Help Desk for both MVS and VSE processing.
  • Created and deployed customer satisfaction surveys for all Technical Support outlets.
  • Assisted chemists by providing technical support and performing routine laboratory functions such as pH analysis and gravimetric analysis.
  • Conduct training and update SOPs; work closely with Technical Support, Regulatory, and Marketing with product transfers.
  • Provide SW technical support to worldwide clients inclusing Samsung, IBM, TSMC, etc.

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35. Product Release

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Here's how Product Release is used in Senior Specialist Quality Assurance jobs:
  • Provided training for new QA Product Release Specialist(s).
  • Prepare routine and non- routine reports for product release metrics.
  • Participate in final product release through batch record review.
  • Reviewed and approved batch records and executed product releases.
  • Ensured products were released per established procedure Supervised the daily activities for three product release quality specialists.
  • Lead Quality Assurance Specialist and Final Product Release functions * Experience in an FDA audit - 2006 & 2009
  • Informed manufacturing of issues pending to ensure product release timelines were met.

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36. GLP

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Here's how GLP is used in Senior Specialist Quality Assurance jobs:
  • Spearheaded recruitment/acquisition of QA specialist to focus exclusively on GLP implementation and audit operations.
  • Provide training to technical and professional staff in GLP regulations; serve as a resource on regulatory issues and GXP compliance.
  • Developed and presented GMP/GLP/GDP training program related to Quality Systems, internal procedures, as well as external regulations and standards.
  • Developed a MS-Access application that tracks GLP audit comments and responses for 5+ years by 30 users.
  • Possess a sound background in GLP compliance and general knowledge of GCP compliance.
  • Experience providing quality/GLP method development activities, method and process tech transfer.
  • Conducted both GLP and GMP internal audits according to established schedules.
  • Perform audits of GLP batches manufactured in Pharmaceutics.
  • Managed Quality Systems/Change Control programs supporting cGMP/GLP compliance operations.
  • Provide support for quality assurance, cGMP and GLP compliance support for pharmaceutical projects.
  • Completed Pfizer training courses for GLP, cGMP, GCP, FDA, USFDA regulations.
  • Ensured laboratory compliance with current Pharmacopeia and cGMP/GLP requirements.
  • Composed/implemented quality systems SOPs supporting cGMP/GLP compliance activities.
  • Provided support & oversight for preclinical safety studies that are conducted in compliance with the FDA, EPA and OECD GLPs.
  • Lead investigations to resolve the nonconformance found during the review to assure compliance with GMP, GLP and SOPs.
  • Conducted/hosted GCP/GLP/Pharmacovigilance inspections and audits (Vendors, CROs and Partners).
  • Provided oversight of clinical and manufacturing operations to ensure compliance with cGMP, cGCP, cGLP, and company procedures.
  • Trained personnel on GLPs, GCPs, and GDPs.
  • Trained personnel on GLPs, GCPs, GDPs, and FDA Guidance for Industry Bioanalytical Method Development (2001).
  • Participate in and conduct cGMP and GLP internal/external audits of Analytical and Bioanalytical Laboratories to assure compliance with cGMP/GLP.

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37. Jira

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Here's how Jira is used in Senior Specialist Quality Assurance jobs:
  • Create, track, review and disseminate software quality reports and JIRA tickets.
  • Defect reporting and tracking on day-to-day basis in JIRA.
  • Generated automated daily reports using JIRA API.
  • Used JIRA for defect management.
  • Manage the setup of QA processes including setup of JIRA and the workflow for Development and QA processes.
  • Created and maintained requirements as stories and defects within Jira.

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38. Sigma

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Here's how Sigma is used in Senior Specialist Quality Assurance jobs:
  • Contributed to Lean Six Sigma Process Improvement initiatives.
  • Utilize the Lean and Six Sigma methodologies improve the facilities overall performance.
  • Implement and participate in Six-Sigma projects.
  • Green Belt in Six Sigma.
  • Work to the philosophies of lean manufacturing, six sigma, and 5S.

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39. OOS

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Here's how OOS is used in Senior Specialist Quality Assurance jobs:
  • Created division's first monitoring system databases in MS Access for environmental discrepancy and OOS information.
  • Handled OOS, laboratory investigations, deviations, and QSE reporting and closure.
  • Work with managers to find the root-cause for OOS/OOT and LIR investigations.
  • Initiate NCRs and OOS reports and lead in the investigations.

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40. XML

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Here's how XML is used in Senior Specialist Quality Assurance jobs:
  • Performed data validation testing and validated XML data files and transaction log files.
  • Utilized the SOAP UI tool to execute XML scripts for interface testing.
  • Validated the XML response received with expected behavior and verify in backend.
  • Prepare xml import files for testing purposes.

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41. Analytical Methods

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Here's how Analytical Methods is used in Senior Specialist Quality Assurance jobs:
  • Collaborated with department supervisors to help troubleshoot problems encountered with analytical methods and sample testing.

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42. GUI

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low Demand
Here's how GUI is used in Senior Specialist Quality Assurance jobs:
  • Reviewed and approved clinical studies and designed raw material qualification guidelines for all categories.
  • Tested entire GUI functionality of applications.
  • Provide guidance and follow up to internal clients in matters of financial stewardship, compliance and other policies and procedures.
  • Developed strategy for asset managers and repair specialists to provide guidance on decision making of repairs for VA assets.
  • Ensured production and release of products were in compliance with Food and Drug Administration and Good Manufacturing Practices guidelines.
  • Approve reports provide technical guidance on interpretation of 2008 NEC code and BS7671 and current KBR electrical work instructions.
  • Provide cross-functional leadership and guidance through the life-cycle of projects and activities to maintain and ensure regulatory compliance.
  • Developed and conducted annual and refresher for Good Practice quality guidelines and regulations (GXP) training.
  • Performed verification of residual payments and DGA PTV payments in compliance with union contracts and company guidelines.
  • Audit documents per ISO 9000 guidelines, develop international standards for documentation, and assist ISO registration.
  • Performed quality reviews of business processes to ensure adherence to state, federal and company guidelines.
  • Provided guidance and assistance by identifying test scope to resources involved with the testing.
  • Provided coaching and guidance as needed to ensure compliance with GMP and corporate standards.
  • Provided QA guidance, interpretation, and assurance to ensure computerized system compliance.
  • Directed GAP analyses for site computer system guidance in alignment with corporate policies.
  • Performed GUI, Functional and regression testing using Win Runner.
  • Verify results via GUI, log files and database queries.
  • Implemented company policies and guidelines while maintaining HIPAA law compliance.
  • Conceived and delivered Design Control guidance and implementation strategies to Development and Project teams as the Quality Management representative.
  • Analyzed and approved complex financial transactions; Assessed financial policies and proposing implementation procedures for new laws or guidance.

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43. Sharepoint

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Here's how Sharepoint is used in Senior Specialist Quality Assurance jobs:
  • Worked with test team on the project progress and track progress via JIRA and save documentation on SharePoint.
  • Utilized SharePoint, Remedy, Quality Center.
  • Reviewed content for external and internal websites using Hyperwave and SharePoint content management systems.
  • Tracked and addressed all issues and bugs using TFS and document storage in Sharepoint.

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44. Html

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Here's how Html is used in Senior Specialist Quality Assurance jobs:
  • Created LoadRunner scripts using the HTML/Terminal Emulator protocols.
  • Maintained QA department intranet site using HTML, JavaScript, and VBScript.

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45. Training Programs

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Here's how Training Programs is used in Senior Specialist Quality Assurance jobs:
  • Conducted training programs and coordinated company initiatives to improve supplier performance and productivity.
  • Develop facility-specific Quality, Food Safety, and Sanitation training programs.
  • Budget, plan, generate for, and execute training programs to assure appropriate equipment and product use.
  • Design and implement food safety training programs for food prep and food service employees.
  • Conduct food safety and quality related training programs for all employees.

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46. Annual Product Review

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Here's how Annual Product Review is used in Senior Specialist Quality Assurance jobs:
  • Manage Annual Product review, Batch Documentation programs, AVL (Supplier Mgr.).
  • Generated and approved different Element Reports for the Annual Product Review (APR).
  • Authored Annual Product Review reports of solid dosage products as a representative of QATT.
  • Approve stability data and protocols and participate in the Annual Product Review report.
  • Involved in Annual Product Review (APR) all the manufacturing products.
  • Maintained and assess data for annual product review reports.
  • Coordinated the drafting and completion of Annual Product Reviews.
  • Assisted in compiling and summarizing Annual Product Review reports.
  • Conduct internal audits & write Annual Product Review.
  • Handled documentation for Annual Product Reviews.
  • Lead CAPA Review Board Prepared and analyzed nonconformance ns data for the Annual Product Review (APR) reports.

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47. Preventive Actions

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Here's how Preventive Actions is used in Senior Specialist Quality Assurance jobs:
  • Reviewed and evaluated corrective / preventive actions (CAPA) associated Third Party investigation of manufacturing deviations.
  • Lead internal compliance audits teaming with area management to implement corrective and preventive actions.
  • Recommend preventive actions as necessary to eliminate possibilities of error.
  • Reviewed and approved corrective and preventive actions (CAPA) focused on the prevention and elimination of the root cause.
  • Verified product labeling changes demonstrated through testing, analysis and Corrective Actions and Preventive Actions (CAPA).
  • Developed and managed the regional Corrective and Preventive Actions (CAPA) tracking program.
  • Evaluated the effectiveness of the corrective and preventive actions (CAPA's).
  • Worked independently to develop, monitor, & recommend corrective and preventive actions.
  • Evaluate and close Corrective and Preventive actions (CAPA) commitments.
  • Focus is on data integrity, discrepancies and preventive actions.
  • Issue corrective and / or preventive actions.
  • Document Lesson Learned and develop preventive actions Prepare Test Release Note and publishing to the Management team.
  • Review, approve, and track facility corrective and preventive actions (CAPAs).

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48. Lims

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low Demand
Here's how Lims is used in Senior Specialist Quality Assurance jobs:
  • Validated installation of LabWare LIMS system to ensure accurate entry of 1500+ finished product specifications including tolerances.
  • Ensured documentation is properly recorded in the Laboratory Information Management System (LIMS).
  • Coordinate establishment of Nautilus LIMS online user manuals.
  • Authorized LIMS data entry and reporting analyst.
  • Use of LIMs where ever necessary for the accuracy of the data Regular auditing of the database and maintaining the accuracy.
  • Author Stability Interim Reports Review and approve data Use of STAR LIMS

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49. Sdlc

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low Demand
Here's how Sdlc is used in Senior Specialist Quality Assurance jobs:
  • Assisted with the remediation of SDLC templates (merging Schering-Plough and Merck SLC processes).
  • Trained QA team in writing testing documentation, scripting within accordance to SDLC guidelines.
  • Developed standard SDLC validation templates for the PR&D and Sales Administration groups.
  • Participated, Communicated and documented issues in various phases of SDLC of the application.
  • Enforced adoption of automation best practices throughout the testing SDLC.
  • Demonstrated mastery of Merck CSV and SDLC policies.
  • Developed System Development Lifecycle (SDLC) documentation for new applications.
  • Assisted project management area with the establishment of realistic SDLC timelines for the QA process.
  • Involved with an effort to update SDLCM documentation toward a CMMi Level II compliance goal.
  • Followed RUP through out SDLC.Responsibilities: Developed Test Plan and overall Test Strategy for the program.

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50. GXP

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low Demand
Here's how GXP is used in Senior Specialist Quality Assurance jobs:
  • Review and Approve Computer Systems/Equipment validation Protocol for IQ/OQ/PQ for new and existing GXP software/applications for the laboratory.
  • Conducted internal/external audits issuing reports and collecting metrics data (GCP, PVG, and GxP).
  • Conducted vendor audits as well as maintained audit log and audit plan for GxP related vendors.
  • Support functional groups in development of standard operating procedures for all GxP activities, where required.
  • Advised and supported management on GxP, quality, risk and compliance matters as requested.

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Senior Specialist Quality Assurance Jobs

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20 Most Common Skills For A Senior Specialist Quality Assurance

Ensure Compliance

19.9%

Test Cases

18.0%

Audit Procedures

7.5%

Product Quality

6.6%

Capa

5.8%

Batch Records

5.1%

FDA

4.6%

Validation Protocols

3.9%

Corrective Action

3.6%

GMP

3.4%

Process Improvement

3.1%

Pl/Sql

2.9%

Raw Materials

2.7%

Management System

2.1%

Customer Service

2.1%

QA

1.9%

QC

1.9%

ISO

1.8%

User Acceptance

1.7%

Project Management

1.5%
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Typical Skill-Sets Required For A Senior Specialist Quality Assurance

Rank Skill
1 Ensure Compliance 15.7%
2 Test Cases 14.2%
3 Audit Procedures 5.9%
4 Product Quality 5.2%
5 Capa 4.6%
6 Batch Records 4.0%
7 FDA 3.7%
8 Validation Protocols 3.1%
9 Corrective Action 2.8%
10 GMP 2.7%
11 Process Improvement 2.5%
12 Pl/Sql 2.3%
13 Raw Materials 2.1%
14 Management System 1.7%
15 Customer Service 1.6%
16 QA 1.5%
17 QC 1.5%
18 ISO 1.4%
19 User Acceptance 1.3%
20 Project Management 1.2%
21 Business Requirements 1.1%
22 UAT 1.0%
23 Trackwise 1.0%
24 CFR 0.9%
25 SQL 0.9%
26 API 0.9%
27 Quality Standards 0.9%
28 R 0.8%
29 QTP 0.8%
30 SME 0.7%
31 Customer Complaints 0.7%
32 Unix 0.7%
33 Document Control 0.7%
34 Technical Support 0.7%
35 Product Release 0.7%
36 GLP 0.7%
37 Jira 0.7%
38 Sigma 0.7%
39 OOS 0.6%
40 XML 0.6%
41 Analytical Methods 0.6%
42 GUI 0.6%
43 Sharepoint 0.6%
44 Html 0.5%
45 Training Programs 0.5%
46 Annual Product Review 0.5%
47 Preventive Actions 0.5%
48 Lims 0.5%
49 Sdlc 0.5%
50 GXP 0.5%
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21,251 Senior Specialist Quality Assurance Jobs

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