Senior Manager, Quality Resume Sample
Destany Becker
128 Arely Field,
New York,
NY
+1 (555) 971 0426
Work Experience
Senior Manager, Quality
01/2017
-
PRESENT
Detroit, MI
- Progressively responsible technical experience in Supplier Quality, Quality or Supply Chain fields
- Strong leadership, problem solving, and written/verbal communication skills
- Experience in the area of Sterile manufacturing with a thorough understanding of pharmaceutical manufacturing operations, laboratory operations, and quality trends. Knowledge of Environmental Monitoring and/or Microbial Control is a distinct advantage
- Experience with preparation of Risk Management’s regulatory submission documents (e.g. Risk Management Plans, briefing documents, etc.)
- Work well under tight schedules/deadlines
- Wearing a static protective smock at all times while in the work area
- Working in close proximity to other employees
Senior Manager Quality
08/2010
-
12/2016
Phoenix, AZ
- Working in an environment that is temperature and humidity controlled
- Able to sit, stand, walk throughout the work day
- Strong Engineering skills and ability to teach tools such as FMEA, 8D, QFD
- Outstanding people skills, with the specific ability to interact as a lead player, apply critical thinking and make decisions
- Demonstrated ability to manage multiple projects/teams
- Black Belt / OPEX / Statistical analysis (SPC) and problem solving tools (Drill Deep Drill Wide, 5Why, 7D, 1X1, etc.)
- PC proficiency utilizing MS Office, MS Project, JMP
- Travel inside and outside the United States
- Coordination of Supplier Audits (planning, training, scheduling with QE’s, conducting, issuing findings, following-up for effectiveness)
Senior Manager, Quality IT Systems
06/2006
-
02/2010
San Francisco, CA
- Proven history in managing FDA inspections and ISO Audits
- Advanced knowledge of FDA QSR, ISO 13485, ISO 9001 and ISO 14001, including practical application of these standards is required
- Strong basic statistics experience, including statistical process control
- Strong project management skills, analytical and organizational skills required
- Communicate effectively with personnel at all levels both verbally and in writing
- Able to communication effectively outside of the organization and to participate on and possibly lead global initiatives
- Travel up to 30% possible
Education
University of California - Santa Cruz
2002 - 2006
Engineer's Degree in Engineering
Professional Skills
- Excellent successful time management skills, including an ability to manage multiple and frequently changing projects and priorities
- Strong leadership and communication skills with experience reporting to senior staff
- Outstanding interpersonal skills and communication skill with attention to detail
- 5) Strong interpersonal/communication/influencing/negotiation skills
- Excellent communications skills needed to facilitate relationships with cross-functional departments and external customers
- Teaching, coaching, and education skills with understanding of adult learning dynamics
- Support and manage the validation process of enterprise software which could include writing and/or reviewing SW validation protocols and reports
How to write Senior Manager, Quality Resume
Senior Manager, Quality role is responsible for leadership, organizational, manufacturing, reporting, training, microsoft, documentation, credit, retail, integration.
To write great resume for senior manager, quality job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Manager, Quality Resume
The section contact information is important in your senior manager, quality resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Senior Manager, Quality Resume
The section work experience is an essential part of your senior manager, quality resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous senior manager, quality responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular senior manager, quality position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Manager, Quality resume experience can include:
- Computer Skills – experience with ERP systems; proficiency with Microsoft Office suite
- Demonstrated Leadership and managerial skills; Integrity, Strategy, Execution & Talent, Customer Passion, Teamwork, Agility, Accountability and Innovation
- A B.S. in Engineering or Science concentration with demonstrated experience working in a healthcare environment
- Good experience in working with third party service providers
- Strong experiences of implementation/upgrading of quality system, i.e. HACCP, GMP, GLP, GWP, ISO
- Good experiences in developing Lab capacity and capability
Education on a Senior Manager, Quality Resume
Make sure to make education a priority on your senior manager, quality resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior manager, quality experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Senior Manager, Quality Resume
When listing skills on your senior manager, quality resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical senior manager, quality skills:
- Excellent documentation and communication skills and interpersonal relationship skills, including negotiating and relationship management
- Good skills of project management and prioritizing by importance
- People/team management skills and business management skills
- Possess expert functional, technical and people and/or process management skills as well as customer (external and internal) relationship skills
- Accountability, solid decision-making skills
- Good skills in human resources optimization
List of Typical Experience For a Senior Manager, Quality Resume
1
Experience For Senior Manager Quality Resume
- Demonstrated Experience managing quality personnel, specifically Quality Engineers, managing performance and developing teams
- Demonstrated capacity to develop validation strategy and lead team to execute
- Multi-task effectively, execute to aggressive timelines
- Relevant experience within a Quality or Senior Quality Manager role Demonstrable experience and sound knowledge of GMP regulations
- Experience using statistically based sampling plans
- Pharmaceutical experience with at least 3 years in a QA/QC position supporting pharmaceutical production and/or testing
- Drive and execution of in-process monitoring, investigations, change controls, CAPAs, and process validation
2
Experience For Senior Manager, Quality CSV R&D Resume
- Good understanding of FDA, WHO and Chinese national Regulations for Infant Formula and dairy products
- Knowledge of Process validation, IQ, OQ, PQ, inspection plan development, process control plans, and DFMEA/PFMEA’s required
- 2) Establishes HACCP Program, drives quality system in place in effectiveness, i.e. QCP, GMP, GLP, GWP, ISO
- Monitoring, tracking and reporting Quality KPIs
- Tracking and monitoring of batch trending data
- Tracking and monitoring of quality control data
- Expanding the general knowledge of Technical Problem Solving throughout the Business Unit
- Understanding of current procedures around Health information privacy and security
3
Experience For Senior Manager, Quality IT Systems Resume
- Execution of product complaint handling, manufacturing investigations, tracking and corrective actions
- Assure completion of weekly, monthly, quarterly internal and executive quality control reporting, monitoring, testing, corrective action, etc
- Escalation point for tasks such as supporting Requests for PPAP and loading approved PPAP’s
- Provides regular reports on quality system health and functioning to the Managing Director of Quality and other Healthcare Logistics senior management
- 3) Provides training and coaching to personnel
- Analyze internal and external customer data from Service, Marketing and Manufacturing
- Serve as a project manager to lead projects (large and small) that result in driving changes necessary for ongoing quality controls and improvements
4
Experience For Senior / Manager, Quality Resume
- Point of contact for all RLU, Retail Lending & Retail Banking compliance related matters on compliance assurance and risk control
- Promote the sharing of best practice and identify areas to improve process and develop more efficient ways of working
- Support the Director on people management in the areas of resourcing, talent development, performance management, learning and development and engagement
- Drive for world class incoming quality (<100 ppm) and permanent corrective action through 8D and other problem solving methodologies
- Knowledge of blue print reading and basic measurement techniques
5
Experience For Senior Manager Quality Contol Resume
- To guarantee the safety of product and people by working in compliance with the site rules and all Enviromental Health and Safety procedures
- Communication with other Catalent sites regarding all aspects of quality and compliance and also quality improvement
- Tasked with reporting of system performance to senior management, external regulatory authorities, and internal audits
- Liaison between manufacturing sites, regulatory affairs, and corporate / divisional functions
- Be the company champion for Quality, Environment, Health and Safety (EHSQ) ensuring alignment across the company on a single strategy and set of best practices
- Work cross functionally with Engineering, Supply Chain, Field Operations, and Service organizations for day-to-day issue resolution
6
Experience For Senior Manager Quality Work Systems Resume
- Quality management within a high tech manufacturing environment with medical products, which include Hardware and Software complexities
- Document control and control of records, measurements, metrics, reporting, and corrective action
- Oversight of all product testing, methods, and investigations
- Work with high level contact and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment
- Provides support and direction to Quality Managers in the field regarding best practices, industry standards, and quality certifications (as applicable)
7
Experience For Senior Manager Quality Industrial Resume
- Represents the Corporate Quality Department at FedEx Supply Chain field locations undergoing audits (e.g. regulatory, customer quality, third party quality)
- Serves as a sustaining resource to the sales and operations groups in their efforts
- Provides orientation and on the job training for teammates as required and ensures teammates understand the authority and responsibilities for each position
- Manage staffing levels, budgets, and departmental goals
- Drive changes in design control as required by the changing regulatory environment
- Coordinate training programs to develop ShaininTM practitioners across the Business Unit
- Assess talent and resource needs in support of short and long term succession planning
- Apply mastery and deep knowledge of ShaininTM and other related processes to unique and challenging concerns with both internal and external customers
- Review product quality performance and assist in developing process quality improvement plan and support implementation
8
Experience For Senior Manager, Quality Resume
- Ensure the outgoing PPM of the products delivered from the plant to established metrics
- Applies total quality management tools and approaches to analytical and reporting processes within each department
- Manage and improve the non conforming material review and control process
- Participate in the performance of customer and Industry accreditation audits of testing and calibration issues
- 3) Understands and assures conformance to regulations applicable to several sections or departments. Interfaces with regulators during inspections
- 7) Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
- Leads in the deployment of physical testing process improvement
- Assures that all material brought for test has been pre-screened for design and performance adherence by the product-engineering department
9
Experience For Senior Manager Quality Resume
- Assures proper execution of failure analysis processes in conjunction with Product Engineering
- Reliability and failure analysis engineering
- Drive and support the implementation of the World Class Manufacturing
- Manage the execution of Manufacturing Quality Improvement Plans
- Lead and manage the manufacturing quality team to ensure successful execution of projects and day to day operations
- Interacts with senior internal / external representatives on significant technical matters often requiring coordination between organizations
- Technical and Food Safety knowledge of preliminary packaging material
- Background in a production setting is preferable
- Be decisive regarding material/quality issues and work independently
10
Experience For Senior Manager, Quality CSV R&D Resume
- Manage a team and oversee the work of assigned quality assurance team. Develop a robust talent development plan in alignment with functional growth strategies of the department
- Manage Professional Compliance and Product Audit program with responsibility for the timely implementation and execution of the audit schedule. Initiate and lead in the investigation of manufacturing product quality and compliance issues. Manage External Inspection / Audit Management & Response
- Manage the Final Quality release activities of all HVT Irvine products. Provide oversight on issuance and effectiveness for non-conformance corrective actions as well as proper closures of all documentation processes prior to final product release
- Manage the training system activities for the Irvine Heart Valve QA group. Establish relationships with QC and Mfg. organizational staff to design and lead the implementation of Product Inspection programs to support the quality integration culture
- Manage Quality objectives while ensuring Quality System compliance. Coordinates objectives with Manufacturing to maximize product reliability and minimize costs. Engage with and collaborate with cross functional management to address quality issues and obstacles and find appropriate solutions
- Interfacing with customers on quality program
List of Typical Skills For a Senior Manager, Quality Resume
1
Skills For Senior Manager Quality Resume
- 4) Strong communication and leadership skills
- 6) Strong project management skills
- Financial services experience. Strong understanding of end to end F&A cycle and Payroll operations flow
- Effectively navigate and lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions
- Demonstrable leadership and organisational skills
- Strong knowledge and broad experience in Quality assurance, Quality Control, and Design activities
- Partner effectively with internal and external partners
2
Skills For Senior Manager, Quality CSV R&D Resume
- Exceptional verbal and written communication skills with ability to synthesize large amounts of data and provide clear and articulate conclusions and/or trends
- Proficient using Microsoft Office applications, including Word and Excel, and data entry experience
- Experience working in a independent capacity, as this role supports quality and food safety programs that impact 24-26 Kellogg manufacturing sites
- Experience designing and developing complex, interactive consumer applications
- Experience in Quality, Manufacturing, Engineering or related field
- Evaluate and set priorities according to business needs
- Experience managing quality programs on major freeway or transit projects
- Supervise and schedule all Final Inspection and Lab and testing activities in order to achieve maximum effectiveness and efficiency
3
Skills For Senior Manager, Quality IT Systems Resume
- Maintain effective operations selection, development, training and motivation of personnel
- Ensure that Gage calibration system is effective and complies with company operating procedures
- Good exposure towards driving PI’s and related Automations. Be on the lookout for opportunities for improvement and to develop new efficient procedures
- Experience in Testing Management tools like HPALM desired
- Experience with CAPA, MES, PLM, SAP, LMS, Complaints Handling and Change Control systems is desirable
- Demonstrated track record in people management including roles definition, team optimization, and conflict resolution required
4
Skills For Senior / Manager, Quality Resume
- Demonstrated success leading teams through influence to achieve goals
- Experience with the use of shop measuring instruments (micrometer, calipers, comparator, etc.)
- Establishes work prioritization and rescheduling recommendations for the product development team managers based on overall master department plan
- Serves as primary interface with internal customers for quality planning, improvement, and corrective actions as it relates to product validation tests
- Communication with all personnel at the site with regard to Good Manufacturing Practice (GMP), quality and regulatory issues
- Cultural change agent experience
- Experience on major design-build freeway or transit projects
5
Skills For Senior Manager Quality Contol Resume
- Good communication with inside department and outside agency
- Good relationship with authority bodies and appropriate communication with all concerned parties
- Identify and implement quality control processes to ensure controls and processes are followed and effective
- Manage and understand customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards
- Proven track record transforming processes, systems and teams, and driving significant change initiatives
6
Skills For Senior Manager Quality Work Systems Resume
- Good understanding of analytical chemistry and testing
- Deep knowledge and experience using Lean and 6 sigma-tools, Green Belt required
- Quality managerial experience in MNC Infant Formula or pharmaceutical manufacturing environment
- Engage with other quality networks toward the effective promotion and alignment of organizational goals to the company’s mission and vision
- Experience with mechanical inspection equipment such as micrometers, optical comparators, hardness testers, and torque testers
7
Skills For Senior Manager Quality Industrial Resume
- Management and people leadership experience required
- Strong knowledge of other applicable industry/regulatory standards
- Advanced knowledge of process/product validation procedures
- A total of at least 8 years QA/QC/R&D management and production experiences
- Assurance of method adherence, expertise and validation
- Previous experience with Gulf Coast maintenance and small cap work
- Experience on complex highway and or transit projects
- Proven success in the medical device or similar regulated industry
8
Skills For Senior Manager, Quality Resume
- CAPA management experience in the medical device industry required
- Proven ability to understand various root cause analysis methodologies such as 8D, 5 Whys, etc
- Systems validation requirements in healthcare environments (e.g. Part 11)
- Five to Eight years of experience in leadership positions
- Demonstrated ability to engage and deliver proactive change processes throughout all functions
- Developing rare solutions to problems impacting quality systems and business processes of product development, distribution, and regulatory requirements
- Disseminating information to the other Quality Personnel on ongoing issues
- Working closely with the Director if Quality to promote Quality culture throughout the injectable operation
- Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
9
Skills For Senior Manager Quality Resume
- Working knowledge of basic and advanced Quality tools such as; TQM, Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, etc
- Reporting on the performance of elements of the QMS leaders as a basis for improvement
- Ensuring awareness of customer requirements is promoted throughout the organization
- Monitoring of performance guarantees
- Fingering. Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling
- Designing and implementing KWS QFS processes, KPI’s, tools, standards and align with a global focus on implementation of best practices
- Expert understanding of CAPA procedures while identifying applications of functional knowledge and existing methodologies to complex problems
- Communication with clients manufacturing and testing sites regarding all aspects of batch release
- Work with CLC’s (Contract Logistics Centers) on packaging, shipping, field installation manuals and field turn backs
10
Skills For Senior Manager, Quality CSV R&D Resume
- Interact positively in all AP countries, recognizing and adapting to the cultural differences that exist
- Provide technical assistance to Manufacturing, Engineering and other support departments on Inspection procedures and operations
- 9) Manages coaching, training and development of subordinates
- Strives to balance the week performing technical tasks and oversight, along with managing people, schedules and/or budgets
- Establishes reliability testing initiative and product improvement process in conjunction with Product Engineering
List of Typical Responsibilities For a Senior Manager, Quality Resume
1
Responsibilities For Senior Manager Quality Resume
- Maintain and improve the site’s Quality System policies and procedures to ensure full compliance with all applicable domestic and international regulations/standards
- Strong understanding of PPAP & ISO-TS16949
- Strong understanding of Automotive OEM and tier 1,2 customer expectations and requirements
- Demonstrated ability to work cross functionally and interact with plant and corporate personnel at all levels
- Directs department activities for the validation function
- Assures all validation programs are conducted on schedule
- Tracking of adverse incidents
2
Responsibilities For Senior Manager, Quality CSV R&D Resume
- Liaise between HVT Quality, HVT Manufacturing, Corporate Quality and HVT R&D to ensure timely and value-adding analysis of CAPAs
- Basic knowledge of all inspection measuring and testing equipment, of SPC methods
- Ensure that all quality department personnel are performing thorough routine quality checks on every actively manufactured part number
- Drives quality and manufacturing improvements to ensure our processes are in state of control
- Financial responsibilities and accountabilities include: department and capital budgeting and expenditures for areas of responsibility
- 16) Budgeting and control expenses
3
Responsibilities For Senior Manager, Quality IT Systems Resume
- 4) Creates suitable working atmosphere, communicates directly
- Ensure that testing operations are performed within guidelines of customer and national accreditation requirements
- Proactive mind set driving continual improvement
- Able to manage multiple projects of varying complexity levels concurrently
- Expertise in CAPA reporting and documentation
- Quality Engineering certification (ASQ CQE, CQA)
4
Responsibilities For Senior / Manager, Quality Resume
- Consistent travel to DanoneNA manufacturing plants
- Act as the site’s key person in all regulatory and quality audits
- Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement
- Escalation point for tasks such as customer notifications, PPAP, annual certification process, and customer complaints through CQE’s for key customers
- Support and improve process improvement for new equipment and modernization product and component change & development to prevent field turn backs and PUI’s (Product Upgrades and Improvements)
- Coordinate and oversee efficient and timely closed loop execution of PUI’s
- Secondary Liaison for Edwards’ Regulatory and Corporate audits
5
Responsibilities For Senior Manager Quality Contol Resume
- Participate in audits, approves audit non-conformity action plans and approve closure of internal audit findings
- Develops and communicates compelling, fact-based rationale that build support for one’s perspectives and initiatives cross-functionally, and helps others to do the same
- Develops and communicates compelling, fact-based rationales that contain strong, logical arguments that build support for one’s perspectives and initiatives cross-functionally, and helps others to do the same
- Provide an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force
- Support the business in leading process improvements by using Lean/six sigma tools to identify areas of improvement. Uses relevant statistical tools to analyze data for proactive improvements
- Evaluate proposed changes and guides the external manufacturers, R&D, and technical operations in establishment of appropriate qualification, validation criteria
6
Responsibilities For Senior Manager Quality Work Systems Resume
- Support new product development within the external manufacturing space. Guides project team in development of qualification/validation plans. Ensure Quality by Design principles are employed and develop robust process control plans for tech transfer
- Provide technical insight into non-conformance investigations. Work with External Manufacturers to identify the root cause and implement systematic corrective actions
- Implement risk management program and tools to drive robust process and product controls
- Identify opportunities to improve the overall performance of the EMQA network and reduce the Total Cost of Quality. Implement programs to continuously transition from failure and appraisal costs to prevention costs
- Liaise with external audit agencies during inspections, recalls, etc
- Function as department supervisor on occasion of the Director’s absence
- Direct the Business Unit’s Quality Programs and procedures to improve cost reduction and enhance efficiency
- Oversees the policies and procedures to insure the public safety, product quality and compliance of OTC Drug, Beauty, Health & Wellness and Fashion & Home Products produced by New Avon’s Supply Chain and Contract Manufacturers which are distributed across the United States, Puerto Rico and Canada
- Establish and implement business strategies with a longer-term focus (typically 3 to 5 years) based on the organization’s vision
7
Responsibilities For Senior Manager Quality Industrial Resume
- Develop objectives and strategies with other leaders of the organization in alignment with facilitation of various programs
- Manage Production Quality workflows including Incoming / First Article, In-Process and Final Quality Inspection. In addition, manage the RMA, failure analysis functions, and assist in resolving customer issues
- Monitor supplier performance, administration of Material Review Board (MRB) and issue corrective actions as needed
- Analyze workflow, yields, requirements, restraints and quality issues to identify potential problems and develop solutions to continually improve the operations
- Manage Regulatory compliance for products and ensure compliance with Privacy and Security requirements
- Ensure all processes and procedures are properly documented, managed, implemented, and monitored. Also, controls and measurements specified in the EHSQ management systems are in place and result in continuous process and quality improvements
- Provide regular reports to management on Organization Quality and the performance of the EHSQ systems. Identify areas for improvement and facilitate detailed plans
- Adopt Lean principles in the development of our procedures. Guide managers and directors in the correct implementation of the Lean QMS and Lean EMS
8
Responsibilities For Senior Manager, Quality Resume
- Coach and mentor employees to instill best practices and promote personal and career development
- Demonstrated leadership ability as well as excellent organizational, listening, and verbal/written communication skills. Ability to work cross-functionally and with all levels of management
- Experience implementing and managing ISO 9001:2015, ISO14001:2015
- Product compliance with regulatory requirements
- Management of internal and external audit programs for ISO standards
- Demonstrated success in applying quality problem solving methods such as fishbone diagrams, FMEA, process capability analysis, 8D methodologies, CAPA, DoE, SPC, etc
- Review CAPA trends to assess the global health of the system and escalate adverse trends to quality and operations management
9
Responsibilities For Senior Manager Quality Resume
- Responsible for CAPA activities across four HVT sites (Irvine, Singapore, Horw and Costa Rica) and oversee the work of a core CAPA team in Irvine
- Ensure that current global CAPA standard operating procedures meet the requirements of US and international regulations for medical devices including 21CFR820, ISO 13485 Canadian MDR, JPAL, and MDD 93/42/EEC, ISO14971
- Ensure completeness, thoroughness and compliance of all HVT CAPA files with relevant objective evidence and assess effectiveness of CAPAs
- Track quality related triggers/sources to ensure these records are escalated, investigated and appropriate CAPAs are opened
- Provide oversight of the issuance, completions and effectiveness of all CAPAs opened to support deviations, audit responses, regulatory observation remediation or regulatory gap assessments
- Provide guidance and expertise to the global CAPA teams to ensure alignment of quality activities
- Oversee internal audits and external audits from various regulatory agencies as CAPA subject matter expert, for global sites Ensure CAPA process continues to be efficient and effective globally
- Interact frequently with senior-level management to inform, influence and achieve objectives
- Provide leadership and lead the development and implementation of methods to improve teams’ effectiveness and performance versus established quantitative measures
10
Responsibilities For Senior Manager, Quality CSV R&D Resume
- Establish and manage department performance to global metrics and goals Develop a robust talent development plan in alignment with functional growth strategies of the department
- Lead quality for product portfolio to internal partners
- Lead QA oversight at CMOs and 3rd Party Labs
- Lead and communicate risks to product, supply, patients, or business, propose solutions, escalate and communicate in an appropriate and timely manner
- Execution and support of vendor audits
- Own preparation of materials for business reviews and routine operational meetings
- Own preparation for business unit Monthly Business Reviews
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