Quality Systems Analyst Resume Sample
Franco Russel
5827 Bertrand Divide,
Houston,
TX
+1 (555) 342 3861
Work Experience
Senior Quality Systems Analyst
07/2017
-
PRESENT
New York, NY
- Analyze complaint, investigation and repair data for trends and make appropriate recommendations for design improvements, process changes or customer communications
- Administrate the internal audit program ensuring all action items and internal audit program activities are performed in a timely manner compliant with procedures and regulations
- Support external audit coordination as applicable including, strategy, logistics and execution in order to achieve smooth and successful external audits and inspections
- Coach audit finding owners to ensure all documentation required is complete correctly and accordance with procedures
- Support special projects in collaboration with team members; identify opportunities for process improvement including developing and proposing solutions, proposing new processes and system enhancements and executing required activities
- Relevant experience in GMP/GLP/GDP environment
- Lead quality system continuous improvement projects for compliance and/or efficiency goals
- Lead business partners in problem solving activities including NC & CAPA
- Own official quality plan projects and / or tasks
Quality Systems Analyst
10/2010
-
05/2017
Dallas, TX
- Act as liaison with corporate change control group
- Act independently to determine daily activities and project implementation
- Daily hold and release procedures for ingredients and finished goods
- Trend analysis and SPC
- Writing and updating SOP’s
- Document Control throughout multiple cross-functioning groups in the plant
- Lead the Complaint Investigation Team; Track and Trend Customer Complaints and Incoming Receiving Ingredient Complaints back to the customer
- Lead Mock Recall efforts as the SAP expert
- Conduct Verification Activities on Plant processes and Measurement Systems
Intern, Quality Systems Analyst
11/2007
-
06/2010
Detroit, MI
- Own NCs and CAPAs related to the Quality System
- Lead system wide projects that cross functional and/or divisional lines
- Lead Internal QSR Audits
- Participate in External QSR Audits
- Assist training team in identifying appropriate QSR trainings for individuals in the organization
- Assist business process owners in the change control process
- Author, review and approve changes to quality system procedures and work instructions
Education
Bluffton University
2002 - 2006
Bachelor's Degree in Information Technology
Professional Skills
- Defines complex issues; recommends and guides implementation of functional strategies; manages departmental/projects day-to-day operations within area of responsibility
- Strong organizational skills, task oriented, excellent time management skills
- Proven ability to apply strong analytical and problem solving skills to create value
- Excellent PC, interpersonal and influencing skills
- Strong data analysis skills leveraging MS Excel pivot tables and similar programs
- Excellent organizational, problem-solving, and analytical skills to lead to sound, timely decisions
- Strong interpersonal, written, and communication skills
How to write Quality Systems Analyst Resume
Quality Systems Analyst role is responsible for training, excel, analysis, mainframe, integration, database, security, architecture, reporting, manufacturing.
To write great resume for quality systems analyst job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Systems Analyst Resume
The section contact information is important in your quality systems analyst 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 Quality Systems Analyst Resume
The section work experience is an essential part of your quality systems analyst 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 quality systems analyst responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality systems analyst position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Systems Analyst resume experience can include:
- Experience using MS PowerPoint and creating presentations
- Responsible for approving the documents required for the development and validation of the computerized system
- Experience with electronic document management applications (such as, but not necessarily including, docspace, tru VAULT, etc.) is required
- Maintain an information data management and laboratory systems as they apply to Good Manufacturing Practices (GMP) and laboratory environments
- Implement and maintain metrics (first pass yield, process capability and control charts) for management review and monitoring system effectiveness
- Interface with suppliers regarding supplier performance and assure that effective corrective action is implemented
Education on a Quality Systems Analyst Resume
Make sure to make education a priority on your quality systems analyst resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality systems analyst 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 Quality Systems Analyst Resume
When listing skills on your quality systems analyst 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 quality systems analyst skills:
- Excellent communication, documentation and teamwork skills
- Excellent communication (verbally, written) and presentation skills
- Thorough understanding of Quality Management Processes combined with strong computer and technology skills to achieve desired outcomes
- Communicating product performance effectively to internal customers
- Training development skills for adult learners
- Data Management experience in a manufacturing environment or an equivalent combination of education, experience and/or training
List of Typical Experience For a Quality Systems Analyst Resume
1
Experience For Senior Quality Systems Analyst Resume
- Strong understanding of data management and applications within SAP and other IT environments
- Experience in a manufacturing environment, preferably in the poultry industry
- QMS system effectiveness and correlation with quality performance
- Align R&D initiatives across IS to maintain clear priorities
- Test related quality systems for accurate and effective design and setup
2
Experience For Business / Quality Systems Analyst Resume
- A demonstrated knowledge of ISO 9001 and 14001 standards
- Managing and administering User Account roles, rights, and privileges
- Understanding of Root Cause Corrective Action (RCCA) analysis
- Lead ISO 9001, 14001, and OSHAS1801 management systems; training internal auditors, developing and leading audit plan; enhance procedures
- Understand and manage business use of Quality KPI metrics (gathering, tracking, and reporting)
- Conduct onboard training regarding Food Safety and Quality functions to new Buff’s
- Aid Business partners in problem solving activities including CAPA and Internal Audit
- Identify business opportunities and offer reporting tools to assist in better decision making
- Track, Trend, and report on failed incoming inspections back to the customer appropriately
3
Experience For Intern, Quality Systems Analyst Resume
- Knowledge of manufacturing processes, GLP’s, cGMP’s, Food Safety and Quality Procedures
- Knowledge of process control and general food manufacturing principles
- Aid Business partners in determining proper metrics and thresholds to ensure health of the quality system
- Responsible for reviewing the new/revised corporate level documents per applicable procedure
- Ensure audit support of customers globally as needed. Serve as a point of contact for inspection readiness planning
- Ensure that users at local site are using the systems in a GMP manner, as per SOP
4
Experience For Senior Quality Systems Analyst, R&D Resume
- Perform an impact assessment on the local SOP, batch record and specifications, and determine impact to overall system (e.g. reports or static data setting)
- Provide training sessions for enhancements to system and new system users
- Serve as a Quality Systems resource for problem identification, CAPA and reporting
- Coordinate individual work assignments, assuring timely completion of task in accordance with project schedules
- Responsible for compliance with departmental policies, procedures, standards, and training
5
Experience For Quality Systems Analyst / Specialist Resume
- Develop and/or augment dashboards and reports using QlikView
- Build training documentation and train users in different environments (classroom, web meetings, etc)
- Provide end users with basic technical support and troubleshooting
- Monitor the Helpdesk ensuring timely technical support and/or master data modifications
- Lead and participate in development or upgrade projects to improve system capabilities and bring new ideas & technology into quality application toolbox
- Troubleshoot technical issues involving SharePoint, user access, TipQA, Solumina, desktop and web issues
- Develops, supports and maintains Global Quality monthly metrics data reporting for all levels of business from executives to Quality Engineers
- Develop monthly performance reporting and SharePoint platform for the QA organization
- Support development of documentation and perform recording of data
6
Experience For UMM Quality Systems Analyst Resume
- Assist with all 3rd party and regulatory audits
- Lead discussions about the current state of the Quality system and help make CAPA determinations
- Work as a team member on the CAPA and Internal Audit teams
- Advise Management on best practices and resource allocation
- Ensure ISO conformance standards for all QMS documents & records; develop & implement documentation for QMS process
- Implement new document control database & system and support processes for change control, NCM, CAPA and equipment calibration
- Develop, manage & report metrics associated with verifying, validating & improving QMS conformance, as well as create process map and streamline Qualify Management Systems
- · SAFETY: Set standards for safe behavior. Recognize and reward safe behavior in others. Ensure that direct reports employ safe practices. Enforce safety policies & procedures. Evaluate staff member’s safety performance & insure that safety is a part of each direct report’s performance appraisal
7
Experience For IT Quality Systems Analyst Resume
- Supports a CSO in all GxP regulations, compliance with internal and external procedures, and all aspects of safe, reliable, and consistent operation of the computerized system. Also considers non-quality aspects of risk management
- Monitors and reviews exception reports for progress and completeness against procedural requirements
- Responsible for overall internal/external audit support
- Responsible for the creation of internal procedures as assigned
- Diagrams business process work flows to prescribed template/format
- Assists in the control and review of process documentation
- Coordinates with team members to support deadlines
- Supports continual process improvement actions and initiatives as process group member
- Recommends and assists in implementation of continuous process improvement initiative
8
Experience For Senior Quality Systems Analyst Configuration Management Resume
- Assesses Feedback tool process suggestions
- Work the assigned process improvement items
- Review process document to ensure compliance to AS9100 and CMMI standards
- Provides status on activities and assignments
- Bakery Organic Certification/Renewal Application Process
9
Experience For Senior IT Quality Systems Analyst Resume
- Bakery Non-GMO Verification/Renewal Application Process
- Proficient in Microsoft Office programs (Word, Excel, Outlook, and PowerPoint)
- Communicate and work with managers/bakery staff at all levels
- Collaborate with business partners to develop/improve processes that use Tru, lead/facilitate the implementation phase
- Prepare and revise specifications for J&J Canada products to meet corporate, regulatory guidelines and requirements. Create/review technical documents
10
Experience For Quality Systems Analyst Resume
- Challenges status quo, seeks out and leads continuous improvement/innovation opportunities in daily work. Connects and collaborates with customers to development and implement value added change. Works with customers to develop business case for project activity and prioritizes projects by value
- Living our Credo as an engaged team member, creating a trusting and collaborative environment. Actively participates in Credo team initiatives locally and regionally
- Gathering, analyzing and reporting on consumer complaint data
- Preparing reports, charts, graphs and presentations; and working with cross-functional teams to resolve and track implementation of changes
- Manages/completes activities as outlined in the Quality and Compliance goals and objectives
- Creates, revises and approves specifications for J&J Canada products to meet corporate, regulatory guideline requirements
List of Typical Skills For a Quality Systems Analyst Resume
1
Skills For Senior Quality Systems Analyst Resume
- Current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), Food and Drug Administration (FDA), and other regulatory requirements
- High learning agility and desire to continuously improve knowledge and skills
- Act effectively as a liaison between business units, technology teams and support teams
- Experience in a quality systems analyst environment, or equivalent work experience
- Root Cause and Investigation skills (desirable)
- Relevant food industry experience, plant quality and systems experience
- Effectively communicate across a large and diverse organization to listen and find opportunities from Voice of the Customer
2
Skills For Business / Quality Systems Analyst Resume
- Experience with the following
- Demonstrated ability to use Microsoft Office tools including Word and Excel
- Business process optimization demonstrating enhanced system effectiveness and efficiency
- Experience using test management tools such as Application Lifecycle Management
- Solid understanding of medical device documentation development activities (desirable)
- Experience managing an ISO compliant Quality Management System
- Related experience in a manufacturing environment or equivalent education
3
Skills For Intern, Quality Systems Analyst Resume
- Knowledge and experience with Aerospace Quality systems including AS9100
- Strong negotiation, facilitation, and influence abilities
- Process thinker: Creativity and ability to develop innovative/effective solutions holistically
- Experience with project management and project management software tools (desirable)
- Teamwork approach and good interpersonal savvy
4
Skills For Senior Quality Systems Analyst, R&D Resume
- Skilled at Project Management
- Proven ability to multi-task in a dynamic environment
- Experience with ISO 9001 QMS
- Program management credentials and demonstrated success with remote teams
- Identify roadblocks, inefficiencies, respond to day to day issues, group needs, and shifting priorities
- Experience in Organic and Non GMO Certification process
- Assist in product and process validation activities
5
Skills For Quality Systems Analyst / Specialist Resume
- Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and techniques for resolution
- Tracking and reporting on quality/food safety initiatives and projects
- Training practices and methods
- Understanding of Root Cause and Six Sigma methods
- Developing Quality Food Safety reports
- Working knowledge of SAP master data and user profiles
- Working knowledge of ETQ Symphony – Change Control and CAPA modules beneficial
- Promotes and expands Compliance and Credo Cultures through training, mentoring and maintaining open communication with all business partners
- Represents the department/project in providing solutions to difficult technical issues including the development of new quality procedures and systems
6
Skills For UMM Quality Systems Analyst Resume
- Publish key measurements and metrics to management during designated periods (month ends, quarterly, planning cycle, etc.)
- Assist in preparing documentation required for the completion of Routing Quality Audits for new or revised Berea product
- Responsible for administration, training and troubleshooting activities in the Global Document Management System (Tru)
- Management of Standard Operating Procedures in Tru (document creation, revision, management and training coordinator)
- Review and release quality records (including manufacturing batch records, work instructions and other related documents) for each production lot
- 99’s, voiding record entry errors, linking “projects to programs”, etc.)
- Assist in improving the quality of products by following AS9100/ISO9001 protocols
- Provide formal and informal training and guidance on process management principles and other procedural training, as needed
7
Skills For IT Quality Systems Analyst Resume
- Maintain a positive work atmosphere by acting and communicating in a manner that is cooperative and supportive of customers, co-workers and managers
- Business, scientific and personal computer software and hardware, system security data collection hardware, operating systems and application software
- Assist in weekly and monthly data trending activities
- Collect department data and provide pertinent and timely analysis for management operational decision-making
- Have a deep understanding of department database and interfaces (e.g., business objects, data warehouse, Siebel, etc.)
- Review all Audit reports for new suppliers for 3rd party product for Manufacturing License updates
- Support bakeries in the continuous improvement of quality/food safety through scoring programs and other quality improvement projects
8
Skills For Senior Quality Systems Analyst Configuration Management Resume
- Business Analytics: develop and maintain analytics and benchmarking that support process improvements
- Represent and influence Bolthouse Farms business needs when working with cross functional or global business partners
- Third level qualification (Science or an Engineering related discipline)
- Creates supporting business process documentation
- Main contact for Organic and Non-GMO Project Certifying Bodies
9
Skills For Senior IT Quality Systems Analyst Resume
- Keep tracking of QFS audits, complaints, Quality Food Safety surveys, etc
- Keep tracking of FDA inspections and Food Safety incidents
- Work under pressure while managing multiple projects
- Provide ongoing support for the Global Quality Consumer Feedback Department and day to day activities to ensure department goals are achieved
- Perform trend analysis on key quality metrics including FPY, DPM, OTD, CRR
- Establish correlation between QMS performance & outgoing quality trends/Customer Sat
10
Skills For Quality Systems Analyst Resume
- Maintain QMS procedures ensuring alignment with ISO9001 & business requirements
- Trend analysis of site QMS data including Internal Audits, CAPA & Mgt Review
- Execute the Global Document Management process for Global Functions across Janssen, including the process for Global Segment documents
- Participate in initiatives to support delivering on Pharm Doc Council objectives
- Cross-train (deliver and receive training) within the department to ensure and provide coverage of activities in times of peak demand
- Provide new user account creation and training as needed for users from Global Functions
- Identify qualified external consultants and experts in government, collaborating with them to insure correct interpretation of LRGS.
- Communicate to end users and corporate team regarding specific events; initiate nonconformance if necessary
List of Typical Responsibilities For a Quality Systems Analyst Resume
1
Responsibilities For Senior Quality Systems Analyst Resume
- Frequently re-prioritize and effectively work on multiple initiatives in parallel
- Several years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience is an advantage
- Related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience
- Proficient in MS Excel, Word and Power Point Skills
- Effectively work on a team, both as a leader and a member
2
Responsibilities For Business / Quality Systems Analyst Resume
- Experience with Personal Computers/Word Processing/DataBases including SAP
- Experience in writing protocols and SOP’s
- Experience working in compliance with Quality System Regulations
- Previous experience working on an Agile team
- Adept at managing drop in requests and provide excellent customer service
- Performs routine system audit trail of validated computer systems in the laboratory per data
- Writes and reviews SOPs, TMs, MSs, and other validated documentation to ensure compliance with local and global procedures
- Validates a variety of laboratory computer systems and instruments
- Set priorities, utilize and coordinate resources, and manage projects from start to finish with little or no supervision
3
Responsibilities For Intern, Quality Systems Analyst Resume
- Experience with Product Lifecyle Management
- Experience with Quality Management Software and Processes
- Demonstrated partnership with leaders and team members at all levels
- Five (5) years Quality Assurance experience in a cGMP medical device, biotech or pharmaceutical environment
- Engineering schematics/drawing/prints reading and interpretation
- General understanding of manufacturing methods and procedures
- Expertise in developing and managing Document Control Database systems
- Executing tests within Web-based, Windows-based, and/or mainframe applications & environments
- Lead auditor training in ISO 13485 (desirable)
4
Responsibilities For Senior Quality Systems Analyst, R&D Resume
- Analyze and adjust to constantly changing quality and regulatory standards
- Analyze and resolve non-routine quality or regulatory issues using independent judgment
- New packaging approval
- Analyze and resolve non-routine regulatory issues using independent judgment
- Keep multiple projects moving forward simultaneously
- To maintain and develop the SOP system in relation to the update, logging and distribution of SOP’s for the entire facility
- Analyze and determine trends in complex data sets and identify where action is required based on the data
- Assist with investigations based on consumer feedback: adverse events, complaints, corrective actions, etc
5
Responsibilities For Quality Systems Analyst / Specialist Resume
- Monitor and track action plans
- Quality data management (complaints, tech support inputs, warranty data)
- Facilitate and lead exercises and projects as directed
- Work with all areas to improve performance
- Facilitate the development of process instructions that insure processes are defined
- Analysis of site QMS data to support bi-annual Mgt Review process
- Identify systemic QMS issues, risks & negative trends (WC/Site)
6
Responsibilities For UMM Quality Systems Analyst Resume
- Perform Root Cause Analysis & drive Corrective and Preventative Actions
- Identify positive trends & best practices. Manage a Best Practice database to ensure proliferation
- Audit and administer CAPA and Audit Mgt processes - Pilgrim SmartSolve® SME
- Provide input and other related support to the Mgt Review process
- Use statistical tools (Mini-tab) to identify negative trends and continuous improvement opportunities
- Communication of Quality Alerts
- Interface with Business Systems Group on next generation JOS applications
- Investigate and analyze technical and regulatory issues (site)
7
Responsibilities For IT Quality Systems Analyst Resume
- Track waiver requests and identify areas for QMS document improvements to prevent waiver usage
- Identify quality system issues and recommend / implement corrective and preventative actions
- Act in the capacity of an internal auditor for the Quality Management System
- Process CA or PA from audit findings and track issues to closure
- Track progress of follow-up items from TUV & Internal audit reports, Mgt Review, Corrective/Preventive Action Requests (8D) and other continuous improvement projects
- Support and/or coordinate process improvement projects and assure coordination with other functions as well as compliance with regulatory, customer and company quality requirements
- QMS system documentation and alignment with requirements
8
Responsibilities For Senior Quality Systems Analyst Configuration Management Resume
- Analysis of key Quality, Operations and other Business Metrics (site trends)
- Identification of business or operational risks and/or best practices
- Identification of Preventative Actions – site
- CAPA Pilgrim SmartSolve® (CAPA & Audit)
- Input and support to Management Review
- Support for ISO Certification program
- Perform on-site Internal Audits against QMS procedures & ISO requirements
- Liaison with regional and sector Operations Development Teams
- Maintain Quality 1st mentality within the organization
9
Responsibilities For Senior IT Quality Systems Analyst Resume
- Ensure delivery of document management responsibilities including training, review and approval of documentation to ensure compliance to procedures, facilitation of the periodic review process, and author/approver coaching
- Provide new user account creation and training as needed for users from Global Functions. Perform user account and qualification reviews for users from Global functions on a periodic basis
- Assist in gathering and analyzing data for metrics / Key Performance Indicators to ensure process compliance and identification of continuous improvement opportunities
- Maintain and ensure compliance of documentation associated with the global process
- Coach local process execution owners on the Document Management process, particularly during communication of revisions, continuous improvement changes and new system deployment
- Support system validation testing
- Provide assistance on any applicable Events/CAPAs related to document management processes
- Knowledge of applicable GDP and GMP Regulations required
- Customer-focused mindset is required
10
Responsibilities For Quality Systems Analyst Resume
- Lead short- and long-term deliverables
- Perform user account and qualification reviews for users from Global functions on a periodic basis
- Ensure audit support of customers globally as needed
- Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in Abbott business processes.
- Identify areas of potential noncompliance within Abbott.
- Review and update the Quality System Manual as needed.
- Educate functional areas on quality system requirements.
- Participate cross functionally and across business units to standardize Abbott business quality system policies and procedures.
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