Quality Systems Analyst Resume Samples

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B Howell

Brittany

Howell

69745 Christian Lakes

Chicago

+1 (555) 228 6310

69745 Christian Lakes

Chicago

Phone

p +1 (555) 228 6310

Experience Experience

Dallas, TX

Quality Systems Analyst

Dallas, TX

Schumm and Sons

Dallas, TX

Quality Systems Analyst

Provide support/resources for Process Testing, sample collection during grade development efforts and project work mill-wide
Assists in the development of Quality and Process Improvement budgets
Assists in creating a culture of quality awareness and communicating the quality management system, GMP and associated documents and procedures to all staff
· POLICIES: Know and follow Sterilmed and Johnson & Johnson policies and procedures related to work activities performed in area of responsibility
· SAFETY: Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter the work area
Assist in change control coordination for external and in-network bulk and packed product for Mylan Ireland
Manages change management processes including

Dallas, TX

Quality Systems Analyst / Specialist

Dallas, TX

Ortiz LLC

Dallas, TX

Quality Systems Analyst / Specialist

Support the implementation of the Operational Excellence Programme on the site by identifying and implementing improvements
To maintain and develop the SOP system in relation to the update, logging and distribution of SOP’s for the entire facility
To administer and develop the Change Control System and Deviation System in accordance with the relevant SOP’s at Mylan Dublin OSD and to coordinate the follow up and closure of all open items in relation to both
To administer and develop the environmental monitoring system
To collate information and assist in the preparation of reports in relation to Annual Product reviews for all products manufactured on site
To administer and develop the on- hold and reject system
To administer and develop the complaints system, including the pharmacovigilance system, in accordance with the relevant SOP’s at Mylan Dublin OSD and to coordinate the follow up and closure of all open items

present

Boston, MA

Senior Quality Systems Analyst

Boston, MA

Larkin-Monahan

present

Boston, MA

Senior Quality Systems Analyst

present

20% Perform analysis and report on trend data. Report and escalate system and process performance metrics to the Business Process Owners (BPOs)
Develop and manage UAT Test Strategy, Test Plan, Test Scenario and Test Summary documentation
Provide input to, or participate in, process improvement initiatives around testing
Develop, gather, and measure relevant metrics and present as part of Management Review
Work concurrently on several projects, each with specific instructions that may differ from project to project
Ensure that quality processes are carried out through all phases of the Software Development Lifecycle
Provide guidance in interpretation and correct application of 21 CFR Part 11 regulation in new and existing systems

Education Education

Bachelor’s Degree in Pharmaceutical

Michigan State University

Bachelor’s Degree in Pharmaceutical

Skills Skills

Ability to make good judgments and quick decisions
Excellent planning and organizational skills with the ability to handle multiple tasks
Proficient in Microsoft Word and Excel, and other basic computer software
Proficiency with Microsoft Excel pivot tables and advanced functions
Excellent analytical and judgment capabilities and communication skills, and the ability to work with management across the plant
Self-starter with the ability to work with little supervision. Good time management skills
Ability to read and interpret Drawings per ASME Y14.5 and Technical Data and Documents
Proficient in Microsoft Word, Excel and PowerPoint at an intermediate level
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Demonstrated experience and skill with intermediate level of Statistical knowledge

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Senior Quality Systems Analyst Resume Examples & Samples

20% Maintain status reports for systems and drive compliance to agreed upon dates
20% Support the BPOs in providing technical, procedural, and compliance based guidance to system users as needed
20% Perform analysis and report on trend data. Report and escalate system and process performance metrics to the Business Process Owners (BPOs)
20% Support the BPOs in follow-up with record owners and tracking and trending of record status
10% Support training for Quality Systems processes as needed
10% Other duties as assigned by management
College degree required
Change Control, CAPA and Deviation experience related to GMP / GDP / Medical Device required
TrackWise experience required

IT Quality Systems Analyst Resume Examples & Samples

10-20% Strategic Partnering
Work with stakeholders to understand requirements and provide operational oversight for the implementation of approved solutions
Keep abreast of technology trends in the market and evaluate for potential value to Shire
40-60% Plan and Build
Establish and coordinate initiatives that are part of the Tech Ops IT portfolio
Evaluate proposed IT infrastructure changes to determine potential impacts to systems operations and compliance
Participate in Tech Ops meetings where appropriate to understand business requirements
Work closely with Shire IT business project teams during planning and design phases to ensure appropriate solutions
Consult during the selection of external service providers
20-30% Run
Implement necessary processes and tools to effectively manage the technical/operational architecture including governance, internal standards, processes, modeling capabilities and operational support
Function as a subject matter expert for Tech Ops IT Quality applications and interfaces and demonstrate ability to solution-engineer application related fixes or projects
Provide configuration solutions and advice and develop customizations, as required, within the context of technical standards
Develop new features requested through requirements gathering from projects, pilots or tests and implement these features specifically or broadly, as the situation dictates
Create system documentation and ensure that application components and design are clearly documented and assessed based on risk
Assist with and contribute to application validation efforts, including installation qualification, operational and performance qualification
Partner proactively with IT infrastructure partners to ensure optimum operational performance of delivered solutions
Bachelor’s degree in information technology, computer science, engineering, marketing and/or business administration (required)
More than 3 years relevant IT/business experience, including project scoping, analysis, and documentation of business and technical requirements (required)
Experience in the Pharmaceuticals or Life Sciences industry (preferred)
Experience consulting or working in a complex, global matrix organization (preferred)
Knowledge of IT Computer systems Validation processes (required)

Quality Systems Analyst Resume Examples & Samples

Drives compliant execution of the following for their assigned processes and projects
Works directly with various customers of the quality system processes to ensure compliance to site, sector/franchise/regulatory requirements
Work directly with the various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner
Compiles contextualizes, evaluates and presents Quality Systems data and metrics for all metric review meetings. Utilizes quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards
Responsible for identifying and communicating the need for process improvement opportunities to responsible management
Support the assigned processes during internal and external audits
Where applicable, conducts internal audits to ensure compliance to regulatory and customer requirements

Quality Systems Analyst Resume Examples & Samples

Gain an understanding of the Company Lab processes, configuration and enhancement points for Labware and SAP QM modules across our various divisions, including integration design with other systems
Design, develop and deliver enhancements in the form of specific mini-projects and change requests in the Labware LIMSand SAP QM systems
Take a lead role from a quality perspective on multiple implementations and continuous improvement projects, including

Quality Systems Analyst Resume Examples & Samples

Ensure consistent and correct execution of Quality System procedures at the site to maintain the quality and compliance of processes and records for Non Conformance, CAPA, Internal Audit Observations, Quality report and Management Review
Develop competency of resources at the site by providing training and guidance on the execution and documentation of Non Conformance, CAPA, Internal Audit Observations, Quality reporting and Management Review processes
Support on site the timely collection, escalation and reporting of Quality System metrics to management
Support the deployment of process initiatives impacting the site that promote the continuous improvement of the Quality System and ensure continuity of the application of globally shared processes and systems at site level
Participate in audit readiness; assist in Internal and External audits; serve as Subject Matter Expert during audits; supporting the investigation, response, and remediation of site-specific Quality System audit observations
Manage on site Document Control, including management of change documentation, on-site administration of the change control system, and archival of documents on site
Bachelor’s or Master’s Degree in Engineering, Natural Sciences or similar
2 years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience is an advantage
Experience in Quality Auditing and notified body inspections is preferred
Advanced use of computer and software applications is required
Ability to analyze, graph, and present data in a way that facilitates and drives decision making

Quality Systems Analyst Resume Examples & Samples

Ensure all quality assurance activities are appropriately satisfied
Build positive professional relationships with internal and external customers
Develop and manage UAT Test Strategy, Test Plan, Test Scenario and Test Summary documentation
Log, track, and manage defects to closure
Champion and apply a risk-based testing approach
Provide input to, or participate in, process improvement initiatives around testing
Apply situational leadership by making effective and efficient testing decisions on behalf of the project
3+ years of experience with testing web applications, Windows-based applications, and / or mainframe systems
MS Office proficiency including Access, Visio, and MS Project
Ability to understand and articulate business / system functionality requirements and / or process flows as it relates to test cases & test results
Ability to meet project-related deadlines
Ability to work as part of a self-directed team where tasks are self-determined, as opposed to specifically assigned
Strong leadership and coordination skills
Excellent interpersonal skills at both an individual and team level
3+ year experience using test management tools such as Application Lifecycle Management (ALM)
Experience in business analysis and / or project management
3+ years UAT testing experience for enterprise level applications including developing and implementing effective test plans and test cases

Senior Quality Systems Analyst Resume Examples & Samples

Participate in User Acceptance Testing (UAT) for multiple functional work areas on varying applications and platforms
Effectively analyze and decompose business requirements into testable components
Mentor other IT Quality System Analysts
Work closely with the Project Team to identify risks and UAT scope early in the project lifecycle
Ensure resource requirements are met for testing environments, UAT cycles and related components required to support adequate test execution
Monitor, measure and communicate test results
Create, prepare, and obtain sign-off for UAT documentation
As required, participate in end-to-end testing cycles across multiple business segments
As required, participate in Business Partner testing cycles with external customers
BS in Computer Science or related field or equivalent
5+ years quality assurance team leadership experience
5+ years of experience understanding all phase of the Software Development Life Cycle
MS Office proficiency including Access, Visio, and Project
Ability to understand and articulate business / system functionality requirements and/or process flows as it relates to test cases & test results
Demonstrate solid understanding of UAT Testing methodologies
Experience with testing web applications, Windows-based applications, and/or mainframe systems
Ability to meet project - related deadlines
Ability to work as part of a self - directed team where tasks are self-determined, as opposed to specifically assigned
Previous experience working with Agile
Previous experience in the Health Insurance industry
5+ year experience using test management tools such as Application Lifecycle Management
5+ years UAT testing experience for enterprise level applications including developing and implementing effective test plans and test cases

Senior IT Quality Systems Analyst Resume Examples & Samples

12+ years of IT experience with a GED/High School Graduate
8+ years of IT experience with Associate’s Degree
4+ years of IT experience with a Bachelor’s Degree
2+ years of IT experience with a Master’s Degree
System validation experience
Knowledge and direct experience in the application of software development lifecycles, document management best practices, and system validation compliance within a regulated environment
Working knowledge of quality system regulations, GMPs and ISO requirements
Practical experience with regulatory compliance and risk assessments including those associated with 21 CFR Part 11
Strong oral and written communication skills including technical writing, presentations and classroom instruction
Proficient with use of Microsoft Office tools: Word, Excel, Visio, PowerPoint

Quality Systems Analyst Resume Examples & Samples

To administer and develop the Change Control System and Deviation System in accordance with the relevant SOP’s at Mylan Dublin OSD and to coordinate the follow up and closure of all open items in relation to both
To administer and develop the on- hold and reject system
Administration/co-ordination of risk assessments
To administer and develop the complaints system, including the pharmacovigilance system, in accordance with the relevant SOP’s at Mylan Dublin OSD and to coordinate the follow up and closure of all open items
To coordinate the Approved Supplier listing for raw materials
To participate in third party audits of Mylan Dublin OSD
To ensure that the systems with a GMP impact are maintained as per written procedures
Support the implementation of the Operational Excellence Programme on the site by identifying and implementing improvements
Any other duties as assigned by the Quality Manager
Experience in a high volume environment
Experience in managing change and seeking continuous improvements

Quality Systems Analyst Resume Examples & Samples

Investigations into OOT Complaints for in-network and 3rd party complaints/issues notified to Mylan
Ensure stability for in-network and 3rd party is scheduled and annual reports provided to Q for review
Review of OOS for stability notified to Mylan by in-network/3rd party suppliers
Review of 200+ in-network/3rd party PQRs for the release sites and notification to QA / QPs of any trends in Q that occur
Review of RFT figures for in-network/3rd party supplier trends and work with 3rd party to assign CAPA, and review all Audit reports for new suppliers for 3rd party product for Manufacturing License updates
Implementation of Quality Risk Requirements (ICH Q9) required by QP release sites to support HA inspections for review of Quality Supply chain requirements
Assist in change control coordination for external and in-network bulk and packed product for Mylan Ireland
Assist in Technical Agreement coordination for outsourced product, and support QA Manager for QA systems for Launch and 3rd party requirements
Experience of Quality Systems in a Pharmaceutical environment would be of benefit
Relevant experience in GMP/GLP environment
Strong organisational skills / ability to prioritize work

Senior Quality Systems Analyst Resume Examples & Samples

Mentor other Quality Systems Analysts
Execute tests within Web-based, Windows-based, and/or mainframe applications & environments
BS in Computer Science, related field or equivalent work experience
5+ years of quality assurance team leadership experience
5+ years of UAT testing experience for enterprise-level applications, including developing and implementing effective test plans and test cases within the Software Development Life Cycle
5+ years of experience using test management tools such as Application Lifecycle Management

Quality Systems Analyst Resume Examples & Samples

Ensure that quality processes are carried out through all phases of the Software Development Lifecycle, while meeting all project-related deadlines
Work concurrently on several projects, each with specific instructions that may differ
Work independently on projects, where tasks are self-determined and not specifically assigned
Work with business partners, systems analysts, designers and programmers to create / analyze required project documents and ensures that quality assurance processes are incorporated
3+ years of UAT testing experience for enterprise-level applications, including developing and implementing effective test plans and test cases within the Software Development Life Cycle
3+ years of executing tests within Web-based or Windows-based, and/or mainframe applications & environments
3+ years using test management tools
Bachelor's in Computer Science, related field or equivalent work experience
Experience using test management tools such as Application Lifecycle Management
Excellent interpersonal and communication skills (written and verbal) at both an individual and team level

Senior Quality Systems Analyst Configuration Management Resume Examples & Samples

Plans, develops/improves, and implements improvements changes to quality system processes and procedures; includes CAPA investigation/corrective action implementation
Reviews change notices for completeness and implements/coordinates the review/sign-off process to effectively place documentation under change control
Subject matter expert providing/assisting support of quality system tools (eg. SAP/DiaDoc); includes training others on tools/processes
Leads process improvement initiatives to continuously improve the effectiveness

Quality Systems Analyst Resume Examples & Samples

Manages change management processes including
A minimum of a Bachelor’s Degree in Chemistry, Engineering, Life Sciences, Pharmacy or similar disciplines required
A minimum of 5 – 8 years of experience working in a regulated industry is required, with strong understanding of GMP standards related to pharmaceutical products
Knowledge of GMP/GLP regulations and guidelines is a requirement
Knowledge of and competence in the application of Health Canada GMPs, ICH Guidelines
Knowledge of Process Excellence tools, thinks analytically and acts decisively
Strong interpersonal skills and effective performance management skills
Strong problem solving, partnering, and communication skills

Senior Quality Systems Analyst Resume Examples & Samples

Analyze business processes and review/write system documentation (design history file) including user requirements, risk assessments, and functional specifications. Ensure compliance of system documentation with procedures and regulatory requirements
Provide guidance in interpretation and correct application of 21 CFR Part 11 regulation in new and existing systems
Understand and follow as appropriate design control, SDLC, quality validation processes and application processes. Quality support for executing the design and development process, including risk management, for software medical devices, 510k and other regulatory submission projects
Support day to day quality operations related to the Change Control process in Trackwise 8
Review and/or update design history file documentation, protocols, system testing, reports, etc. Review executed verification/validation testing or other computer system records to ensure they are complete, accurate and compliant with cGMP requirements
Provides support to business functions and IT concerning quality issues and ensure conformance to established performance requirements and procedures
Quality support in executing the complaint/CAPA/MDR/FCA processes relating to software devices
Own key tasks, require moderate direction, and handle moderately complex problems
Stays current with federal, state, local and company-specific rules, regulations and practices
Develop, gather, and measure relevant metrics and present as part of Management Review
Identify ways to improve efficiency and effectiveness of processes as part of the Quality Management System (QMS) for software devices meeting changing business needs and regulatory / quality requirements

Quality Systems Analyst Resume Examples & Samples

Bachelor's degree and 2 years of relevant industry experience OR Associate's degree and 3 years of relevant industry experience OR High School diploma/GED and 5 years of related industry experience
Demonstrated experience with MS Office Applications
Demonstrated experience leading Problem Solving and Process Improvement teams
Results oriented, hands-on analyst with a strong work ethic who can operate effectively in a global collaborative environment working on multiple projects of varying size and complexity
Strong deviation, CAPA, and/or change management experience
Experience in regulatory inspections and responding to observations
Experience with training, coaching, and leadership
Practical understanding of principles of project management and team facilitation
Demonstrated knowledge of Excel with some VBA experience
Demonstrated use of LEAN and Six Sigma Tools. ~BSP
Interstate travel may be required. #LI-GZ

Quality Systems Analyst Resume Examples & Samples

Minimum of 5 years of experience with Quality Systems analysis, compliance, and maintenance
Minimum of 5 years of experience with AS9100
ASQ CQA, RAB or equivalent auditor certification

Intern, Quality Systems Analyst Resume Examples & Samples

Extract and organize large amounts of data generated from the Burn In stress chambers
Allow remote status tracking and data mining of other critical stress chambers within the lab
OCR program to automate and improve an existing IC chip serialization capability
Generate Statement of Work (SOW) based the Reliability Engineer’s requirements
Execute the SOW, with regular inputs and check points with the Engineer on program progress
Work with the Quality Systems Analyst to formulate and follow architectural and coding structure
Recommend technical and architectural structure for the programs in development
Evaluate system in test environment
Coordinate implementation of system to live database
Local applicants only
Experience with coding in Python, HTML, Java Script, SQL, and VBA in Excel Programming
Experience with Software Testing and Implementation Planning
Self-direction, work independently
Able to prioritize daily activities with minimal oversight
Work well in a team environment
Good decision making and Problem solving skills
Effective communication skills (Written and Verbal)
Ability to flex schedule as needed
Preferred Major: Computer Science, Computer Engineering, Computer Technology Management
Data analytics & reporting

Business / Quality Systems Analyst Resume Examples & Samples

Analyzes business needs, documents requirements and translates needs into functional, non-functional and/or technical specifications
Delivers requirements, performs analysis, and evaluates downstream business, systems, process, and/or organizational impacts
Plans and assists with oversight of testing processes and activities including defect identification and resolution
Analyzes charts and/or diagrams of the problem to be programmed and defines system requirements in terms of system capabilities
Develops or assists in the development of work plans, time schedules, and project task items and schedules and assists with estimating resource needs for analysts, programmers, user personnel, consultants, equipment, and prepares routine project status reports
Assists in the development of project cost and benefit estimates to establish project worth including the development of alternative considerations. This will result in recommendations for the installation of new systems or equipment, or to change existing systems and equipment
Advises the appropriate people on the implications of existing IT systems that can be applied to a problem. Identifies risks and issues, and seeks approval on complex matters
Checks, instructs, assigns work, and otherwise functionally directs technical staff in order to achieve desired end-results on complex problems
Provides subject matter expert and operational support to internal business partners
Bachelor’s degree in computer science or related field required. (4 additional years of comparable work experience beyond the required years of experience may be substituted in lieu of a bachelor’s degree)
8+ years experience in developing requirements and performing system analysis
5+ years experience of major software systems implementation experience
Strong understanding of the Software Development Lifecycle (SDLC)
Ability to analyze and document process and data flow
Ability to clearly communicate ideas and solutions
Ability to effectively work with both internal and external clients
Knowledge of Health Care Industry and related business functions
Experience in Medicare Claims and Medicare Risk Adjustment
Advanced course of study in information technology, business or other field
Experience with project management and project control methodologies
Experience process re-engineering and best practice implementations

Quality Systems Analyst Resume Examples & Samples

Responsible for assuring a system/application meets its requirements and is compliant with applicable Baxter QMS documents, and the documentation set outlined in the Validation Plan for the project
Responsible for creating the documents required for the development and validation of the computerized system
Supports a BPO in all GxP regulations, compliance with internal and external procedures, and all aspects of safe, reliable, and consistent operation of the computerized system
Responsible for reviewing the new/revised corporate level documents per applicable procedure in areas of responsibility
Responsible for the reviewing/updating internal procedures as assigned
Demonstrates leadership and accountability
Train fellow employees on computerized systems, lab systems, and related lab equipment as needed
Develop execute validations for manufacturing processes and laboratory systems. Insure completion of all protocols and validations in a timely and appropriate manner. Report progress of protocol and validation work and significance of results. Recommend utilization of the results or changes in the scope of work or termination of projects
Ensure compliance with testing SOPs and specifications
Performs a variety of projects/studies in areas that may include Product/Process, sterilization, Cleaning and Equipment Validation, as well as projects/studies to support Manufacturing Operations
Writes protocols, reports, and change controls. Conducts studies/executes protocols
Serves as project lead with projects of intermediate scope and cross-functional teams
Minimum of a BA or BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience -- e.g. education or employment in sciences or validations) with a minimum of 3+ years related experience or 2+ years related experience w/ an advanced degree or demonstrated performance within Technical Services
Excellent analytical and judgment capabilities and communication skills, and the ability to work with management across the plant
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Ability to make good judgments and quick decisions
Proficient in Microsoft Word and Excel, and other basic computer software
Direct or indirect industry knowledge
Experience with maintaining LIMS applications and associated databases such as Oracle is helpful with role responsibilities
Experience with crystal reports and working with databases in order to setup the crystal report is helpful with role responsibilities
Experience with installation, administration, and maintenance of virtual server environment is helpful with role responsibilities
Familiarity with programming languages, such as SQL, etc
Ability to work independently or in teams
Ability to walk some distance 1-3 miles, stand for 3-6 hours and lift 10 - 40 lbs during the course of a work day as required. Ability to work any shift (1st, 2nd or 3rd) and any day of the week (7 days) as duties require

Quality Systems Analyst Resume Examples & Samples

· Ensures quality systems are effectively deployed. Performs periodic checks to verify appropriate application
· Uses statistical methods, quality tools and computer generated reports to continuously improve process capability. Leads and participates in quality system improvement & initiatives in a cross functional environment
· Determines root causes of quality issues and develops corrective actions and recommendations and documents results in the appropriate quality system
· Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business
· Provides audit back room support (for Notified Body, FDA, or customer audits) as required
· Monitors and reports Quality Management System metrics
· Monitor and track alignment to J&J Quality Standards and any other quality system initiatives
· Creates and revises documentation in change control process to improve quality system processes as needed
· Committed to building a positive culture
· Other responsibilities may be assigned & not all responsibilities listed may be assigned
· POLICIES: Know and follow Sterilmed and Johnson & Johnson policies and procedures related to work activities performed in area of responsibility
· TRAINING: Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments and for implementation of new policies & procedures. Complete required periodic re-training in areas such as environmental health & safety
· SAFETY: Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter the work area
· procedures. Complete required periodic re-training and assure that required periodic re-training takes place for direct reports in areas such as environmental health & safety
· 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
Required and Preferred Experience and Skills
· Education, Skills, & Experience Needed to Perform Position Function
· Bachelor degree or equivalent experience is required
· 1+ years in Quality Systems is required
· Experience in FDA regulated industry is required
· Knowledge of 21 CFR Part 820, ISO 13485 and familiarity with ISO 14971 is required
· Prior experience in the medical device industry is preferred
· Knowledge of Microsoft Office is required
· Ability to function independently as well as part of a team is required
· Excellent written and verbal communication skills are required
· Ability to manage multiple priorities in fast-paced environment is required
· ASQ Certification and/or Six Sigma training desired
· Project Management/Excellence; Quality Systems and ISO regulations
· Familiarity with any of the following is preferred: EZDOC, EtQ, ComplianceWire, Siebel, Microsoft Professional Office Suite (MS Word, MS Excel, MS Outlook, MS Access)
· This position is located in Plymouth, MN and may require some travel.Quality (Eng)

Quality Systems Analyst Resume Examples & Samples

Creates, distributes and manages reports as required
Maintain database of information and provide to regulators and certifying bodies as required
Gather and provide information for PL customer requests
Maintain document control system, both electronic and paper
Maintain FDA registrations
Organic program management and other programs as required
SharePoint system administrator
Develop, monitor and track action plans
SME on current regulatory and certifying body requirements e.g. Organic, Kosher
Other duties may be assigned as required
Working knowledge of cGMP for foods and dietary supplements
Working knowledge of Quality (QA/QC) in a dietary supplement manufacturing environment
Preferably with experience in report development and data mining
Experience working in manufacturing and regulatory environments would be a benefit for the associate in this role
Knowledge of regulatory requirements for supplements, including knowledge of CFR part 111
Analytical thinking/problem solving
Ability to Influence others
Ability to data mine Oracle PQM and other databases
Proficient in Computer Software: Oracle, PQM, Microsoft Word etc
Proficiency with Microsoft Excel pivot tables and advanced functions
Exhibit positive attitude regarding work and responsibilities
Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures
Continuously look for ways to do things faster and better, while maintaining high quality standards

UMM Quality Systems Analyst Resume Examples & Samples

UMM Programming required
Bachelor's degree in engineering, business, or related required
Excellent PC skills including Excel, Word, Powerpoint
Familiar with the requirements of AS9100
Knowledge of SAP highly desired
US Citizen or green card holder required

Quality Systems Analyst Resume Examples & Samples

5+ years aerospace experience in Quality Assurance related fields
Skilled at supporting internal and external audits for QMS
Must be familiar with standard Visual and Mechanical Inspection techniques and tools
Ability to read Drawings and other Technical Data required
Good communication skills required, both written and oral format
Ability to successfully interact with both internal and external customers on a variety of technical solutions
Confidence to enforce Quality Management System policies and procedures, while also working as part of a Team
Mechanical Inspection hands on experience
First Article (AS9102) Documentation experience a plus

Quality Systems Analyst Resume Examples & Samples

Administer and manage the finished product specifications database
Audit specifications for accuracy
Manage customer specifications by updating the finished product specifications database and maintaining communications with customers
Implement updates/programming and train users on the finished product specifications database
Assist in annual review of customer specifications with Production, Customer Service, Sales and Customer Solutions Group
Manage the Finished Products Visual Standards to ensure customer success
Manage and update the Test Equipment Manual
Administer and audit the International Standards Organization (ISO) Quality System to ensure compliance
Assists in the development of Quality and Process Improvement budgets
Develops and administers testing equipment daily reference checks
Manages the annual calibrations and certification processes for test equipment for the site
Responsible for site testing equipment, including purchasing, training, calibrations, reference checks and routine maintenance to ensure compliance
Assist in the validation of Finished Product Work Instructions and stand operating procedures for the paper test lab
Develops knowledge base in TPM/lean concepts, with the learned ability to lead problem solving activities to drive continuous improvement in area of responsibility
Administer and maintain all quality reporting systems in the Arkansas production areas
Management of reporting systems, including daily and weekly quality reports and Typical Average Value Reports
Provide support for Customer Certificate of Analysis (COA)
Participate in weekly Quality Conference calls, acts as host as needed (back-up)
Provide support/resources for Process Testing, sample collection during grade development efforts and project work mill-wide
Use proven data collection and analysis techniques to correlate data, make recommendation for corrective and/or preventative action and plans, driving to resolution of issues
Work with teams to ensure that requirements documentation is complete and appropriate, ensuring that the proper testing plans have been completed
Provide Capability Analysis and Quality Systems Analysis Reports
Participate in daily/weekly stand-up and other KPI-driven meetings
Participate in or leads Quality Assurance projects and problem-solving activities
Collaborate with Engineering, Maintenance, and Production teams in the development of documentation, investigations and resolution of quality issues
Prepare and present findings to business partners in writing and orally to assist the business partners in determining the best corrective actions to be applied
BS Degree in Engineering, Management Technology, Natural Science or equivalent education required
Minimum 4 years’ experience in the Pulp and Paper Industry strongly preferred
General knowledge of Process Testing and Testing Equipment required
Excellent planning and organizational skills with the ability to handle multiple tasks
Proficient in Microsoft Word, Excel and PowerPoint at an intermediate level
Demonstrated experience and skill with intermediate level of Statistical knowledge
Strong analytical and troubleshooting skills, including data verification

Quality Systems Analyst / Specialist Resume Examples & Samples

To participate in the internal audit schedule
To administer and develop the environmental monitoring system
To maintain and develop the SOP system in relation to the update, logging and distribution of SOP’s for the entire facility
To administer the TSE/BSE and Residual solvent compliance systems for all raw materials and contract manufactured materials by ensuring that the appropriate certification is on file for all materials
To collate information and assist in the preparation of reports in relation to Annual Product reviews for all products manufactured on site
To ensure that good GMP standards are maintained at all times
To ensure company procedures regarding controlled drugs are followed and assist in the audit of logbooks as required
Minimum of a Bachelor Degree in Science or related pharmaceutical discipline
Track record with the HPRA/FDA is desirable
A proven identifiable track record of success in a similar environment
Have an understanding of, or exposure to Operational Excellence principles
Proficiency in speaking, comprehending, reading and writing English is preferred

Senior Quality Systems Analyst, R&D Resume Examples & Samples

Adheres to environmental policy and procedures and supports department environmental objectives
Leads the change management, NC, investigation, CAPA and complaints day-to-day activities
Writes and issues stability protocols, addenda, reports, etc. including interacting with cross-functional groups to identify and implement study requirements and design
Leads the improvement/implementation of change management, NC, investigation, CAPA, and complaint handling best practices, policies, and procedures with specific focus in simplifying and standardizing the R&D quality system processes
Utilizes quality tools and science to track, trend, and analyze quality performance metrics. Identifies and takes action to prioritize and implement proactive quality systems and quality process improvements
Facilitates quality assurance and/or cross-functional projects regarding new product development processes and quality system improvements
Interacts regularly with temporary employee(s) and contractor staff to ensure an adequate flow of work activities including study setup, sample submissions, data retrieval and tabulation for existing studies, complaints handling, etc
Develops and conducts or coordinates quality systems training
A Bachelor’s Degree in scientific or engineering discipline is required
Minimum of 5 years of experience
Minimum of 2 years working experience in quality assurance, quality systems, quality control, scientific research or regulatory compliance. Graduate scientific degree can be considered in lieu of experience
Strong knowledge and understanding of quality systems in a regulated environment and/or strong knowledge of scientific methods
In depth understanding and knowledge of a broad set of regulatory requirements and ability to interpret regulations (GMP, ISO, ICH, WHO, etc.)
Ability to effectively manage projects that include cross-functional teams representing diversified areas
Excellent communication, organizational, negotiation, influencing, and interpersonal skills required
In depth understanding of lens manufacturing and stability principles and practices
Working knowledge in statistics and statistical applications1605170518

Senior Quality Systems Analyst Resume Examples & Samples

Analyze field failure data (complaints and service events) from both domestic and ROW customers, looking for failure trends by product, manufacturing site, and/or specific customer accounts
Interface with the KSI Complaint Handling process
Bachelor’s degree required (Engineering preferred)
6 years of work experience in medical device regulatory, compliance and/or quality systems required
Experience in auditing of medical device quality systems preferred
Experience in leading cross-functional teams to accomplish goals and objectives required
Experience in training groups and in public speaking preferred

Senior IT Quality Systems Analyst Resume Examples & Samples

Lead in the assessment of IT systems software and applications to meet business needs
Lead in the selection, development, configuration, validation, and implementation of IT systems
Assist/conduct users training; Perform on-going maintenance and systems upgrade
Responsible for communicating process and functional requirements to the quality teams (R&D, sustaining, operations, post market)
Participate and lead projects in various areas of Quality Systems and Reporting with main focus on Complaint Management and Risk Management
Experience developing requirements and functional designs for global technology solutions
Experience in facilitating small to large groups through challenging discussions
Knowledge of SAP (e.g. Business Objects and Lumira) and other BI Applications (e.g. Spotfire and Tableau, Cognition Cockpit), Microsoft Excel macros, Cognos, Blue Mountain, Trackwise, Solidworks, etc
Ability to quickly learn new business areas and processes
Innovative problem solving skills with the ability to identify problems, drive to root cause, develop, and implement solutions independently or as part of a team
Self-motivated to make recommendations and initiate assignments that will improve business processes and systems
Goal oriented, task driven decision-making with a strong sense of accountability
Ability to interact within different levels of business and IT management; good organizational skills
Ability to manage multiple complex priorities
Strong oral, written, and interpersonal communication skills
Knowledge of 21 CFR Part 11, systems validation methodologies, HIPAA, and FDA regulatory requirements
Experience with working as part of a global team in a fast-paced environment
Advanced degree in Computer Science or business related discipline