Associate Quality Resume Samples
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Associate Quality Resume Samples
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RL
R Lesch
Ryleigh
Lesch
8952 Ferry Plain
San Francisco
CA
+1 (555) 155 0911
8952 Ferry Plain
San Francisco
CA
Phone
p
+1 (555) 155 0911
Experience
Experience
Los Angeles, CA
Associate Quality Analyst
Los Angeles, CA
Emard-Feest
Los Angeles, CA
Associate Quality Analyst
- Reporting on error trends and providing on-going training/support to Sellers, thus overall improving the quality of submission
- Documents defects found during QA inspections into a data base and/or hand held data collection device on a defect tracking sheet
- Monitors call center volumes and makes suggestions regarding production and scheduling
- Providing statistical reporting to management around the quality of submission by each of their teams respectively
- Benchmarking the quality of applications signed by customers against that being keyed by the individual sellers to the system
- Data Record Management in the form of archiving completed applications from the process
- Working at a different location in a Continuity of Business situation
New York, NY
Associate Director Quality
New York, NY
Leannon Group
New York, NY
Associate Director Quality
- Sound financial stewardship, management and control
- Drive the Quality Team's performance so that every individual understands their individual contribution and how it impacts the site
- Develop and/or administer and maintain the Employee Training Program, including all GMP-related training for the facility
- Develop and/or administer cGMP training regularly to the facility, including orientation of all new regular and temporary personnel, and contractors
- Contribute to the design and implementation of best practice quality improvement programmes and company expansion programmes
- Propose, implement and enforce quality improvements
- Manage and facilitate documentation of CAPA commitments and respective tracking and trending process
present
Detroit, MI
Associate Director, Quality
Detroit, MI
Schowalter LLC
present
Detroit, MI
Associate Director, Quality
present
- Mentor site leaders to use practical problem solving to drive constant improvements in quality, productivity and cost
- Proactively work with field installation teams to achieve 100% out of box quality for every installation
- Serve as a SME for operations is a regulated environment (GMP). In addition, act as Sensei for teaching improvement methodologies resulting in a gemba and visual workplace daily management environment
- Transition culture to a lean thinking enterprise using principles of Muda, Muri and Mura. Drive continuous improvement projects to advance processes and capabilities
- Support policy deployment activities to define quality strategic objectives and metrics across the organization
- Manage a cross functional program for internal compliance auditing
- Provide training of company employees on the principles of quality systems, validation, statistics, sampling plans and process improvement
Education
Education
Bachelor’s Degree in Life Science
Bachelor’s Degree in Life Science
Carnegie Mellon University
Bachelor’s Degree in Life Science
Skills
Skills
- ) Ability to work well independently, as well as part of a team
- ) Ability to assess process data for trends and indicators
- ) Ability to control and maintain a large database tracking both hardcopy and softcopy programmatic documentation
- ) Proficient in Microsoft applications and PowerPoint
- ) Familiarity with Quality Management Systems - AS9003, ISO9001 and AS9100
- ) Secret or Top Secret Security Clearance with the ability to obtain a TS/SCI w/Poly
- ) Effective written and verbal communication skills
- ) Greenbelt / Blackbelt Certified
- ) Familiarity with the concepts, theories and principles behind statistics
- ) Familiarity with alpha numeric filing systems
15 Associate Quality resume templates
Read our complete resume writing guides
1
Associate Quality Analyst Resume Examples & Samples
- Assist Special Investigation Officer with potential fraudulent claims, including investigations, reporting to applicable businesses, Department of Insurances and/or legal or law enforcement bureaus as defined by law
- Have a working knowledge of all programs administered under CAS, in order to accurately present recommendation for dispositions
- Monitoring/scoring the quality of service provided by the Claim department and assisting in the coaching and training to correct any substandard performance to improve the overall quality of the claims being processed with special attention to potential fraudulent claims
- Report metrics and trending to the operational team and management regarding both fraudulent claims and the quality of audited claims. Interact with employees in a positive manner and work remotely as needed
- 4 years or more claims examining experience and understand programs & procedures with ability to train
- Medical terminology or equivalent experience required (as defined by product)
- Emotional stress in dealing with difficult/angry customers and suspects
- Must be detailed oriented and have good organizational skills
- Self-motivated, effectively handle competing demands and ability to overcome potential resistance to change
- Must be able to review the contents of a claim file and accurately assess and score in an impartial manner & any potential fraud
- Law enforcement and Department of Insurance investigators, customers, suspects and management
- Good coaching skills with the ability to effectively convey feedback to team members and identify areas of potential growth
- Responding to difficult customers/employees
- Working at a different location in a Continuity of Business situation
2
GFI Quality & Metrics Associate Resume Examples & Samples
- Drive and manage Process Improvement projects using simple concepts of LEAN by partnering with LOB’s
- Develop business process understanding by deep dives
- Perform data analysis and data mining exercise
- Document observations, solutions/ ideas. Track and measure project success
- Support implementation of solutions by liaising with business or technology team or other groups as required
- Create detailed project plans and hold regular touch-point calls/meetings with stakeholders to closely track the progress
- Engage in building metrics for business
- Drive Q&M related initiatives
- Manage stakeholders across business and work with them to identify opportunities
- Bachelor’s or Post graduate degree in Accounting & Finance, or Business with 8+ years relevant experience in banking operations or Finance
- Experience in Quality/LEAN/Sig Sigma/BPMS/Project Management
- Six Sigma certification/Green Belt/Black Belt preferable
- Passion – Self motivated and positive personality
- Change leadership -
3
Associate Quality Analyst Resume Examples & Samples
- Benchmarking the quality of applications signed by customers against that being keyed by the individual sellers to the system
- Fulfil AML checking for all new applications as per latest AML requirements
- Reporting on error trends and providing on-going training/support to Sellers, thus overall improving the quality of submission
- Providing statistical reporting to management around the quality of submission by each of their teams respectively
- A high level of operational administrative work around sorting, scanning, indexing and filtering areas of the application to the relevant department and/or institutions
- Ensuring applications are logged and tracked at every stage of the process in a proficient manner
- Data Record Management in the form of archiving completed applications from the process
4
Associate Director, Business Quality Resume Examples & Samples
- Lead the effective implementation of the Quality Management system for Consumer businesses in China. Ensure ongoing compliance to local regulations of all J&J products marketed by Consumer Local Operating Companies (LOC) in China
- Be the Primary Quality partner for the business /commercial organizations. Partner with cross functional teams internally to ensure compliance of all products with local regulations at all times
- Continuously monitor and improve quality systems & procedures to ensure full compliance to Quality Policy, Enterprise standards, WW Procedures and Guidelines. Participate in global/regional reviews to ensure applicability for LOC execution, proper gap assessment and mitigation plan execution
- Lead Quality Systems Management review for LOCs, Product review, Quality Review Board, Product discontinuations and Field Actions for the LOCs. Partners with various functions within China and Asia Pacific (North Asia Leadership Team, Supply Chain, Regulatory Affairs, R&D, Product Development, Marketing, CD, CLS among others) to meet business objectives
- Ensure implementation of the end-to-end complaints vigilance process. Lead the periodic review of complaints & adverse events with the appropriate local and regional stakeholders as defined in the QMS, and track needed actions to address adverse trends
- Lead preparedness of LOC for regulatory inspections/audits, issue resolutions with Local Authorities and company management. Lead investigations, corrective and preventive actions for issues detected potentially affecting the products or to improve compliance with regulations. Keep country management aware of Quality and Compliance related issues/systems through periodic Management Review Process and issue escalation
- Manage and develop a capable organization. Be responsible for budget, staffing, career planning, training & development and providing for a safe & pleasant working environment for all quality employees. Ensure acceptable behavior and performance by the Quality team
- Around 10 – 15 years of experience in the field of Quality Operations and Regulatory Compliance within the regulated pharmaceutical / Medical Device industry
- Comprehensive knowledge of Chinese Regulations applicable to Drug, Quasi-drug, Cosmetic, & Medical Device products, for design, development, manufacture, supply & post-market surveillance
- Regulatory inspection experience is highly desirable
- Proven track record of leading the Quality & Compliance function of a Multinational Pharmaceutical/Cosmetic industry is highly desirable
- Track record of successful cross functional partnership and experience in managing virtual teams in a highly matrixed environment
- Superior written and verbal communication skills in English and Mandarin ChineseCompliance
5
Associate Quality Inspector Resume Examples & Samples
- Min 3 year diploma degree in Mechanical / Electrical / Instrumentation
- AWS or CSWIP Qualification
- Internal / External Auditor Qualification
- TQM
6
Quality Verification Associate Resume Examples & Samples
- Support quality and compliance guidelines by providing quality verification support for all processes/units with a high degree of accuracy
- Design and deliver effective Broker-Dealer industry training, systems training and some job training
- Review systems, images, and paperwork to accurately quality check items processed
- Continuously review and analyze current processes for opportunities of efficiency and/or cost savings
- Improve consistency by creating and updating checklists and job aids
- Identify error trends and training needs of employees
- Develop and update job aids
- Perform operations processing functions when necessary
- Participate in projects, as assigned
- High School diploma with some college preferred
- 3 years’ experience in the financial services industry
- Requires ability to analyze and research information
- Requires a basic understanding of products/services/systems used in all units within Allstate Financial Services, LLC
- Requires proficiency in Microsoft Office applications
- Requires advanced oral and written communication skills
- Requires ability to maintain a high level of confidentiality
- Requires ability to work independently, manage time appropriately, and utilize decision making skills
7
Associate Quality Professional Resume Examples & Samples
- General Area: Budgets own time to carry out assigned duties that support business goals. Interacts constructively with employees, managers and cross-functional peers. Completes compliant documentation and provides solutions to local problems of low scope and complexity. Supports project work and acts as community member
- Quality System Compliance
- Complaint Evaluation: Investigates standard complaints. Provides solutions to local problems
- Design Control / Documentation & Change Control: Identifies needs.Provides reasons and justifications in support of change
- Apprenticeship or Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience
- 0-2 years work experience in this job area
- Quality or related field experience preferred
- Demonstrates basic understanding of regulatory requirements in the healthcare environment
8
Associate Quality Professional Resume Examples & Samples
- General Area:Budgets own time to carry out assigned duties that support business goals. Interacts constructively with employees, managers and cross-functional peers. Completes compliant documentation and provides solutions to local problems of low scope and complexity. Supports project work and acts as community member
- Quality System Compliance: Maintains awareness of industry regulatory standards. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to the department manager. Works effectively within the team
- Risk Management: Applies basic Risk Management principles to work
- Problem Solving: Receives general direction. Makes simple decisions. Carries out tasks related to area of responsibility with management oversight
- Design Control / Documentation & Change Control: Identifies needs. Provides reasons and justifications in support of change
9
Associate Director Quality Resume Examples & Samples
- Develop, implement and communicate a clear strategic vision for quality to maximize employee focus and develop a competitive advantage. He/She will maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems. The successful candidate will bring an expert-level understanding of quality principles and regulatory knowledge
- He/She will have proven ability to maintain strong relationships with customers, regulatory organizations and other industry contacts. This will enable the incumbent to anticipate changes in the quality/ regulatory climate, and redesign processes accordingly. It is crucial that this individual quickly gain the credibility and respect of his/her team, customers, and the senior executives of other functional areas within the site and Company, particularly with operating leadership. This will require the ability to satisfy the twin needs of compliance and productivity
- Ensure Quality systems are compliant with corporate and site procedures as well as industry standards such as but not limited to Annual Product reviews, Complaints, Investigations and root cause analysis, Corrective and Preventive Actions, and Training
- Manage the Batch Disposition team
- Participate in Regulatory Inspections and Customer Audits
- Author/compile monthly, quarterly and annual summaries and metrics; present summary data to site management/customers on a regularly scheduled basis
- Participate in the site Management Review
- Facilitate Investigations and root cause analysis
- Facilitate the Complaints process
- Facilitate the Annual Product Review process
- Manage and facilitate documentation of CAPA commitments and respective tracking and trending process
- Author and maintain detailed Standard Operating Procedures defining Winchester’s Quality Systems
- Function as the Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives
- Recommend process changes as a result of trends from CAPA/Complaints and APRs
- Ensure effective communication and dissemination of CAPA and Management Review commitments
- Subject matter expert in the TrackWise, Documentum, and other Quality driven software platforms
- Develop and/or administer and maintain the Employee Training Program, including all GMP-related training for the facility
- Develop and/or administer cGMP training regularly to the facility, including orientation of all new regular and temporary personnel, and contractors
- Track, monitor, and coordinate cGMP-related training for the facility
- Enforce cGMP compliance through the Employee Training Program
- Maintain positive employee relations, including problem resolution process
- Responsible for communicating and implementing HR policies within Department
- Maintains proper documentation related to employee performance and timekeeping records, administers employee discipline as appropriate and in coordination with Human Resources
- This position requires exemplary communication and organizational skills and the ability to work in a fast-paced cross-functional team environment to accomplish its responsibilities
- Ensure Quality System programs such as CAPA, Management Review, complaint investigations, APRs, TrackWise, ComplianceWire, and the Employee Training Program remain current to achieve customer satisfaction through compliance and commitments communicated
- Participate in FDA Inspections and customer audits as required
- Ensure the adherence to the standards of quality ruled by current cGMPs and the Company’s Quality Policies and site Standard Operating Procedures
- Author/review and ensure currency of SOPs related to the area of responsibility
- Propose, implement and enforce quality improvements
- Demonstrated experience of the internal audit process and FDA regulations, including 21 CFR 210 and 211, and to some extent 21 CFR 800 covering medical devices
- Must have a demonstrable record of implementing and maintaining a total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics. This person will assure that systems are in place and that inter- and intradepartmental communications are such that “things be done only once – the right way.”
- Must have a demonstrated track record of talent management; building bench strength and setting clear objectives for performance and accountability
- Successful development and implementation of a quality strategy for a commercial manufacturing operations environment. Successful in implementing consistent standards
- Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment is preferred
- Comprehensive knowledge of regulatory organizations and requirements – FDA, OSHA, environmental groups, as well as international regulatory agencies and demonstrated experience facilitating inspections
- High level of proficiency in computer skills, including publishing tools, databases, word processing, project and spreadsheets
- Proven ability to manage multiple complex regulatory projects
- Experience in supervising and mentoring junior staff
- Detail-oriented with ability to accomplish objectives
- Clear thinking/logical with strong personal organization skills
- Able to work within a diverse, cross-functional team in a matrix organizational environment
- Demonstrated competence in both written and verbal communication
- Willing to travel (domestically and internationally)
- Capacity to work within a fast-moving and demanding product development environment
- Completion of administrative duties as indicated by position
- Data entry and use of computer user interface tools including mouse, keyboard and any other applicable instruments
- Lifting and operating in an office environment
10
Associate Director, Quality Auditing Resume Examples & Samples
- Maintain professional expertise and knowledge of company policies and international regulations relative to Good Pharmacovigilance Practices (GVP) and Quality
- Collaborate with PV organization to ensure understanding and acceptance of the roles and responsibilities as well as ensure acceptance of all quality processes and procedures
- Provide guidance and direction on PV Quality matters
- Develop and execute strategic audit plans for PV activities including internal processes, service providers, vendors and collaboration partners
- Ensure visibility to PV and IOPS management of any noted deviations or deficiencies or quality signals/trends for improvement
- Participate within cross-functional team to implement an effective CAPA system for PV program and ensure timely closure of CAPAs
- Participate in Inspection readiness and Inspections as assigned
- Promote a GxP and Quality mindset at all levels
- Ensure that all quality based deliverables are complying with regulatory and quality policies and procedures, timelines are met and observations are corrected
- Ensure that all the appropriate PV Audit SOPs are in place and that the appropriate level of training and comprehension is achieved at all times
- Manages staff as assigned to work with project teams on their quality deliverables
- Coaches, develops and mentors Quality employees
- Ensures safety and operational standards are maintained
- Senior Manager/Manager, PV Quality Auditing
- PV Auditor; Sr. PV Auditor
- Expertise in GVP/GCP quality systems
- Thorough knowledge of GxP requirements and international laws/regulations governing management of PV
- Solid team player able to function within a fast-paced culture
- Substantial experience presenting, interacting, and building effective relationships with representatives from regulatory agencies
- Excellent communication and presentation skills (articulate and persuasive)
- Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with internal and external professionals
- Teaches and coaches others in technical and leadership areas
- Strong decision-making abilities
- Self-directed and ability to take action with limited oversight
- Disciplined, detail-oriented and strong time management skills
- Working knowledge of word processing, spreadsheet, database management statistical analysis, graphing, presentation, and scheduling software
- Minimum BS in life sciences
- A minimum of 10 years experience in the pharmaceutical/biotechnology industry (biotech preferred) and PV/auditing
- A minimum of 5 years in a managerial capacity
11
Associate Quality Analyst, Citimortgage Resume Examples & Samples
- BS/BA degree or equivalent combination of education/experience
- 3+ years experience utilizing extensive practical knowledge of Underwriting/Audit/Default Servicing
- Thorough knowledge of Default Servicing and State document requirements. Analytical, problem-solving, and negotiating skills
- Excellent written and oral communication skills and ability to communicate at all levels
12
Local Quality Responsible Associate Resume Examples & Samples
- Generate quarterly reports for the overall review and management of the affiliate, including collection, compilation, reporting and analyzing relevant data for Medical Compliance Metrics, and Passport support
- Prepare and organize the Quality and Training Committee
- Keep the awareness of the international regulatory requirements of GCP, GVP and best industry practices with the help of the regional group and HQ, and encourage affiliate shared knowledge
- Identify areas for improvement related to quality and compliance providing appropriate solutions
- Provide support and training to promote data quality in clinical study systems. monitors through reports / metrics to ensure the quality of the information in computer systems (CTMS, eTMF, PDMS, CTP)
- Escalate consultations of local problems and ensures that end-user feedback is properly reported within Roche and CRO partners
13
Associate Director Biologics Quality Resume Examples & Samples
- Ensure contract service provider meets requirements on the Quality Agreement
- Review/approve change requests generated internally or by external manufacturers ensuring the change is well documented and technically sound
- Investigate and/or evaluate manufacturing and laboratory deviations or incidents. Ensure robust evaluation with sound action plans
- Exchange with PIP members on Quality Best Practices
- Perform “on the floor” oversight of processes including laboratory testing being executed at the contract manufacturer
- Set example of compliance through actions. Awareness of changes to regulation and recommend changes or actions to adhere to changes
- Write, review, approve and implement SOPs to ensure compliance with current BMS standards and CGMP
- Review and approve validation/qualification protocols and reports for new and existing products and processes from the contract supplier as specified in Quality Agreements
- Once the product is commercialized, review performance of the product in meeting essential quality parameters through the Annual Product Review
- Assist in preparation of audit observation responses
- Develop quality assurance network within BMS to assure alignment with BMS processes
- Represent BMS at FDA or any HA inspections as well as BMS GMP compliance audits at the contract service provider as defined in the relevant Quality Agreements
- In collaboration with other Biologics External Manufacturing partners, ensures contract service provider meets expectations for deviation and product disposition cycle times
- Manage and develop a staff of Quality professionals supporting manufacturing/testing at the contract service provide
- Written and verbal skills must be excellent
- Excellent interpersonal skills that foster cooperation and commitment
- Technical proficiency for evaluation of investigations
- Must be able to prioritize multiple duties and projects
- Proven record of leadership in a biopharmaceutical environment with effective skills in managing quality operations unit and delivering on operational requirements
- 1604192
14
Associate Director Quality Risk Management Resume Examples & Samples
- Responsible for direct Quality Risk Management (QRM) Site support
- Accountable for planning, leading and coordinating activities involved in the design/development, implementation and governance of a harmonized Quality Risk Management program including standards, business processes, tools and training for the Site
- Responsible for partnering with customers at Sites, key stakeholders and management, to communicate/escalate and ensure timely and adequate management of quality risks
- Able to travel a minimum of 25% of the time
- QRM Program Design and Deployment
- Implement QRM program for the site
- Develop and implement site QRM business processes in alignment with the QRM CoE program, including integration into QMS
- Quality Risk Reporting and Communication
- Manage site quality risk log/register & report site QRM metrics and status to the site, and appropriate global groups
- Ensure Site Risk register is maintained
- Develop and implement risk escalation model at the Site in alignment with the QRM CoE program
- QRM Expertise & Facilitation
- Provide leadership, QRM expertise and facilitation QRM activities at the Site
- Accountable for execution/facilitation review/approval of site level QRM activities
- Ensures schedule based risk reviews occur
- QRM Training Program
- Ensures that all those involved in QRM activities are trained per the QRM CoE training plan
- QRM IT Tool Implementation
- Responsible for supporting the implementation of the QRM IT tool for xx sites including training of users on the tool
- Quality Systems knowledge
- Exposed to application of Risk Management tools and methodologies such as: FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc
- Fast learner and can be a change agent
- Technical understanding of Biologics, vaccines and small molecules business
- Understanding of Merck’s Quality System
- On the floor manufacturing shop experience
15
Emind FY ADV Quality Champion Senior Associate Resume Examples & Samples
- You would work with various project teams, facilitating and deploying suitable processes. You would help the project team in doing metrics analysis and root cause analysis. You would identify suitable process improvement initiatives and drive the same within the organization
- Individual Contributor role
- BE/BTech/MCA & MBA with a sound industry experience of 3 to 5 Yrs
- Facilitate process to project teams
- Able to analyze metrics of the project
- Should be able to drive process improvement initiatives
- Should be able to define process for the teams
- Should have experience in project audits and reviews
- Be passionate about Quality Management
- Be a graduate, preferably in Engineering
- Have more than 3 years of experience in Software Quality
- Should have participated in CMMI initiatives, preferably as an ATM or FAR member
- Desirable to have PMP certification
- Should be able to handle change management and interact across different layers within the organization
16
Associate Quality Analyst Resume Examples & Samples
- Investigate and analyze scope of defects as required
- Documents defects found during QA inspections into a data base and/or hand held data collection device on a defect tracking sheet
- Routes forms to respective manager in a timely manner
17
Associate Director Quality Resume Examples & Samples
- Communicate, where appropriate, with the Corporate Compliance group, on areas of common interest
- Communicate, where appropriate, with all corporate personnel and contribute to the development of global systems and procedures, as required
- Contribute to the design and implementation of best practice quality improvement programmes and company expansion programmes
- Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents
- Contribute, as required, to the development of new drugs, which will deliver a robust product pipeline without significant delays in the regulatory approval process
18
Trans Quality Assur Associate Resume Examples & Samples
- Works in the architecture, definition, facilitation and implementation of quality processes and standards in alignment with business objectives by adopting best practices from industry standards/models
- Drives continuous quality improvement through strategy, quality management systems and metrics for measurable results to achieve customer delight
- Ensures conformance/compliance to the organization's Quality Management System in alignment with corporate/industry standards
- Conducts audits, analyzes audit findings, suggests actions to improve quality of products and services, and tracks for closure
- Plays a key role with the teams and ensures that all areas within the business unit perform to the defined standard
- Consolidates various metrics parameters, analyzes trends, identifies/develops corrective/preventive actions plans to influence improved business performance, and customer satisfaction
- General knowledge of procedures and activities within own work area
- Ability to relate actual day-to-day work to business priorities
- Focused on learning the key aspects and duties of the job being performed
19
Associate Director Quality Resume Examples & Samples
- Ensure supply to ensure straight through product flow and to ensure the team meets all product quality and compliance requirements to enable disposition for each batch, through the implementation and oversight of the Quality Management System for the IPT
- Lead Quality Team providing ongoing coaching and support to all Quality Team members, including the identification and development of key talent and skills within the team
- Drive the Quality Team's performance so that every individual understands their individual contribution and how it impacts the site
- Sound financial stewardship, management and control
- Degree or 3rd level qualification (Science, Quality) - Desirable Microbiology or Biotechnology
- Desirable QP qualification
- Preference for Lean Six Sigma Green Belt
- Quality and Process background
- Proven track record of providing independent Quality expertise to Manufacturing functions
- Proven track record of delivering high performance through development and coaching of a team
- Demonstrated ability in holding team members accountable for results and managing performance
- Demonstrated ability to fully realize improvement initiatives
- Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc
- Advanced PC skills such as Excel, Word, PowerPoint
- Stakeholder management of multiple decision makers, corporate colleagues, auditors, cross functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc.)
- At least ten years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a management / leadership role in a Quality function. It is desireable that candidate has experience with Biological Drug Substance operations
- Quality experience in contract manufacturing is desireable
20
Associate Director Quality Resume Examples & Samples
- Responsible for direct QRM Site support
- Responsible for Site implementation of business processes for integration of Quality Risk Management into relevant elements of the Pharmaceutical Quality System (PQS)
- Able to travel 10% of the time
- B.A. or B.S. degree (preferably in Science or Engineering) and at least 6-8 years experience in the pharmaceutical, biopharmaceutical, medical device, or related industry
- Demonstrated capabilities in facilitation, preferably risk assessments using risk management tools per ICHQ9 guidelines
- Expert knowledge of cGMPs and/or Quality System regulations
- Collaborative Leadership - Ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment. Demonstrates tolerance for ambiguity
- Experience with application of process improvement tools and methodologies such as: LEAN/Six Sigma especially in areas of Supply Chain Management/Manufacturing/Engineering or Process Development is highly preferred
- Able to take accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations. Makes quality-based decisions and resolves problems rapidly. Asks "what can I do to help?"
- Able to demonstrate good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicates influences and escalates issues and decisions as needed
- Ability to communicate effectively up and down, at all levels
- Technical understanding of Site processes
21
Associate Advanced Quality Eng Resume Examples & Samples
- Assist AQE in development of the Past Problem History Roadmap
- Assist AQE in development of APQP documentation
- Support Measurement System Analysis (MSA) Launch plans for the Launch. Execute plans, collect data, and facilitate other gage related activity
- Assist AQE in the preparation and on-time delivery of new product Launch related Customer Production Part Approval Process (PPAP) packages
- Assist AQE with any Launch related customer, internal and/or supplier quality corrective actions (8D’s)
- Facilitate delivery of Launch related components and product samples as needed to support Advanced Quality deliverables
- Participate in Appearance Approval activities as required
- Support execution of capability studies
- Assist with preparation of IMDS compliance documentation
- Attend and participate in System Simultaneous Development Team (SDT) meetings as required
- Assist/support Supplier Quality Engineer, as needed, including supplier selection, kick-off meetings and process sign-off
- Support DV/PV builds, including verification that parts meet dimensional and functional requirements
- Execute Launch related inspection plans and containment plans as directed
- Support Internal Audits as required
- Perform other duties as assigned by Supervisor
- Bachelor's degree in Quality, Engineering, or Science related field
- Good mechanical/technical skills and ability to read engineering drawings are desirable. GD&T proficiency is highly desirable
- Excellent problem solving aptitude. Experience preparing problem solving documents such as 8D’s is highly desirable
- Experience with ISO/QS/TS Quality Systems is highly desirable
- Knowledge of Advanced Quality Planning methods is highly desirable
- Experience with automotive quality requirements is highly desirable
- American Society for Quality certification, such as current CQT status, is highly desirable
- Experience working directly with customers and suppliers, particularly automotive related is highly desirable
- Ability to efficiently execute assigned tasks with minimal oversight
- Proficiency in use of a computer and common office software (i.e. Word, Excel, and PowerPoint)
- Strong interpersonal and communication skills, including ability to work in a self-directed environment
22
Associate Director, Aggregate Report Quality Resume Examples & Samples
- Investigate and collaborate with IT to improve outputs, as well as act as a subject matter expert in technological tools to facilitate transfer of aggregate reports and listings to PV Reports
- Collaborate with their counterparts in the Regulatory organization to ensure the quality of each aggregate submission
- Serve as subject matter expert for global Health Authority compliance by interpreting and applying PV regulations and guidelines of individual adverse experience (AE) and aggregate reporting globally
- Collaborate with and maintain effective working relationships with the Global Safety community and external customers to ensure compliant adverse experience and aggregate safety reporting while also meeting quality standards
- Liaise with Business Partners to ensure compliance with aggregate data exchange
- Liaise with country PV to ensure standardization and optimization of aggregate safety reports
- Possess the ability to address questions and provide leadership to the ARQ team, as well as escalation to management, if necessary
- Prepares and responds to Regulatory Agency Inspections, as well as internal and external audits
- Monitor Regulatory/Health Authority Aggregate Assessment Reports and requests for information and ensures implementation of appropriate actions to address compliance and quality issues
- Process incoming communications from internal and external sources related to regulatory guidance for aggregate safety reports and initiates appropriate course of action and/or response
- Ensure timely updates of applicable SOPs
- Candidate is required to have at least 5 years of safety/pharmacovigilance experience or related areas such as Clinical Risk Management, Clinical or Regulatory
- Strong working knowledge of PV regulations (spontaneous and clinical) and safety systems for collection of adverse event information and global aggregate reporting
- In-depth understanding of business processes and objectives of customers
- Proven ability to collaborate across divisions to drive results
- Function at a high level of autonomy
- Excellent written and verbal communication skills including presentations to senior management
- Technically proficient in Argus Safety and reporting functionality
- Ability to identify compliance risks and develop solutions to minimize risk and improve quality management
- Ability to lead cross-functional working teams to achieve PV objectives
- Ability to quickly adapt to changes in business priorities and effectively manage competing priorities
- Technically proficient in Microsoft Excel and Spotfire
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Associate Quality Analyst, Optum Resume Examples & Samples
- Responds to and performs routine or standard quality audit or specific quality project requests
- Does work independently most of the time, yet also depend upon others for instruction, guidance or direction as needed
- Some proficiency in understanding of basic process management and total quality management principles and methodologies (e.g., Six Sigma; Lean)
- Basic understanding of relevant organizations' operations, products and applications, strategies, processes, and/or business priorities in order to build effective solutions
- Consistently provide direct support of Quality auditing activities to validate process performance and share findings with QA leadership
- Support the analysis of quality auditing findings as it relates to business process information (e.g., metrics; analytics) to identify key issues, trends, and potential root causes (e.g., training issues; lack of understanding by user community) that point to improvement opportunities
- 1+ years of Revenue Cycle Experience
- 1+ years of experience in a quality analyst role
- 1+ years of healthcare experience
- Basic MS Office skills including Word, Excel and PowerPoint
- Basic to Intermediate Excel experience with proven analytical ability that support successful outcomes
- Basic SharePoint experience including navigation and basic functionality or similar collaborative software experience
- Effective verbal and written communication and presentation skills with the ability to communicate to a variety of levels within the organization including executive leadership
- Proven record of positive and effective team interactions
- Prior experience in large, multi-function and cross geographic organizations
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Associate Quality Specialists Resume Examples & Samples
- Batch record review,
- Investigations,
- Product quality reviews,
- Completion of internal audits and review and approval of validation related documents
25
Associate Director, Quality Resume Examples & Samples
- Mentor site leaders to use practical problem solving to drive constant improvements in quality, productivity and cost
- Ensure efficient handling and resolution of customer complaints to assure an ongoing world class experience by the customer
- Proactively work with field installation teams to achieve 100% out of box quality for every installation
- Serve as a SME for operations is a regulated environment (GMP). In addition, act as Sensei for teaching improvement methodologies resulting in a gemba and visual workplace daily management environment
- Transition culture to a lean thinking enterprise using principles of Muda, Muri and Mura. Drive continuous improvement projects to advance processes and capabilities
- Support policy deployment activities to define quality strategic objectives and metrics across the organization
- Manage a cross functional program for internal compliance auditing
- Provide training of company employees on the principles of quality systems, validation, statistics, sampling plans and process improvement
- Write and review validation protocols. Review the summarized results of validation studies in final validation / engineering reports
- Serve as Quality core team leader/member on project teams. Participate in and provide input to project teams to assure that FDA and international requirements are incorporated as part of product development process
- Serve as Management Representative
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
- Coordinate the corporate corrective and preventive action program (customer complaints, audits, recalls, field corrections and process changes) to ensure timely follow-up, completion and documentation of corrective actions
- Establish procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA, and ISO third party audits
- Manage consultant audit program
- Builds effective, cross-functional teams that accomplish project objectives on a prescribed schedule and with a prescribed budget
- Work with business process owners to identify and implement solutions to track cost of poor quality
- Establish and support best practices for problem solving, root cause analysis, and solution selection tools
- Provide subject matter expertise during internal and external quality system audits
- Represent functional area in Management Review and Quality Review processes
- Provide management with plans and status updates on assigned responsibilities and goals and escalate issues in a timely fashion
- Participates in the definition of area goals and drives teams to deliver on goals
- Lead a team of dedicated Quality Engineers for Instrument manufacturing and sustaining engineering of related supply base
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Associate Director, B Quality IPT Resume Examples & Samples
- Demonstrated leadership and management experience working with cross-functional teams on complex projects
- 5 years’ experience in the Pharmaceutical industry
- Aseptic/sterile processing experience
- Previous Quality Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing
- Live Virus Vaccine Manufacturing experience and/or Quality Systems experience
- 3 years’ experience in a supervisory/management capacity
- Demonstrated proven leadership experience with domestic and international regulatory agencies in a compliance/inspection setting
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Associate Quality Analyst Resume Examples & Samples
- ) The individual will be responsible for producing the monthly Hardware and Software Corrective Action Board packages, supporting the CAB, taking CAB meeting minutes and action items and posting them for easy retrieval by program personnel
- ) Bachelors degree from an accredited college in a related discipline, or equivalent experience/combined education
- ) Strong problem solving skills, and ability to think creatively
- ) Ability to work well independently, as well as part of a team
- ) Ability to assess process data for trends and indicators
- ) Ability to control and maintain a large database tracking both hardcopy and softcopy programmatic documentation
- ) Proficient in Microsoft applications and PowerPoint
- ) Effective written and verbal communication skills
- ) Secret or Top Secret Security Clearance with the ability to obtain a TS/SCI w/Poly
- ) Familiarity with Quality Management Systems - AS9003, ISO9001 and AS9100
- ) Greenbelt / Blackbelt Certified
- ) Familiarity with the concepts, theories and principles behind statistics
- ) Ability to interface across disciplines to obtain required data and information to complete statistical analyses
- ) Familiarity with alpha numeric filing systems
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Associate Director Quality, Vaccines Resume Examples & Samples
- Champion the highest Quality and compliance standards for the IPT
- Champion Permanent Inspection Readiness for the IPT
- Demonstrated knowledge in more than one pharmaceutical and/or Biologics manufacturing operation (e.g. Quality, Science etc.)
- At least ten years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a management / leadership role in a Quality function
- Knowledge and experience in interpreting current regulatory requirements and providing independent support to a manufacturing operation
- Degree or 3rd level qualification (Science, Quality). Desirable Microbiology or biotechnology
- Evidence of Continuous Professional Development
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Associate Quality Analyst Resume Examples & Samples
- Utilizes basic knowledge of theories, practices and procedures in a specific Optum360 revenue cycle function
- Responds to and performs routine or standard audit or specific project requests
- Uses existing procedures and facts to solve routine problems or conduct routine analyses
- Demonstrates understanding of basic process management and total quality management principles and methodologies (e.g., Six Sigma; Lean)
- Demonstrates basic understanding of relevant organizations' operations, products and applications, strategies, processes, and/or business priorities in order to build effective solutions
- Demonstrates understanding of upstream and downstream impacts to partners of business process operations and solutions
- Support engagement with relevant stakeholders (e.g., end users; SMEs; sponsors) to establish appropriate criteria and goals (e.g., efficiency; effectiveness) in order to direct investigation into problems and potential solutions
- 1+ years of experience in an analyst role
- Basic SharePoint experience including navigation and basic functionality
- Basic knowledge of Project Management
- Effective analytical and negotiation skills with a proven track record for innovative successful outcomes
- Experience in large, multi-function and cross geographic organizations
- Experience in Revenue Cycle Management environment
- Experience working in a healthcare related field or earned credential through formal education (ie: degree or certificate in healthcare field)
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Associate Director, Biologics Quality Resume Examples & Samples
- Acts as the responsible Quality representative related to development of biologics manufacturing processes including technical transfer, scale up, QbD, validation strategy and works closely with the Amicus Technical Operations team and the vendor
- Oversees the investigation of manufacturing deviations, laboratory investigations, temperature excursions and product complaints. Ensures robust evaluation with sound CAPA plans
- Ensures CMO meets expectations for deviations, OOS, CAPA and product disposition as per the active Quality Technical Agreement
- Review/approve change requests generated internally or by external manufacturers ensuring the change is well documented, technically sound and adequately actioned
- Write, review, approve and implement SOPs to ensure compliance with current AMICUS standards and cGMPs
- Review and approve validation/qualification protocols and reports for new and existing products and processes from the CMO as specified in Quality Technical Agreements
- Technical proficiency for evaluation of laboratory and manufacturing investigations
- Development of dashboards for reporting KPIs
- Problem solving skills
- Effective interpersonal skills that foster cooperation and commitment
- Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met
- Highly organized and ability to manage multiple priorities
- Working knowledge of MS Office suite (Word, Power Point, Excel, Visio)
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Associate Quality Analyst Resume Examples & Samples
- Assist with the initiatives of the organization in the development, implementation and improvement of the appropriate Quality Management Systems throughout the operation, with all the documentation required. This includes providing advanced quality planning support in the development and launch of new processes and services
- Plan, organize, and lead general quality engineering projects. Analyze Cost of Poor Quality (COPQ) trends and coordinate problem solving efforts utilizing appropriate Continuous Improvement (CI) or Lean Tools (e.g. Root Cause Corrective Analysis (RCCA), 5 Why, Fishbone, etc.) Assist in the development of new or improved processes that minimize scrap and rework and meet technical guidelines and business requirements
- Manage the internal Quality System Audit program. Develop, implement and audit of inspection and test plans, standards and acceptance criteria, and procedures / work instructions. Maintain corrective action program, and facilitate the Investigation and elimination of causes of quality problems and follow up on corrective actions
- Participate in Material Review Board (MRB) disposition on production non-conformances to ensure compliance with internal and customer requirements utilizing knowledge, continuous improvement tools, engineering resources, and assistance of more experienced engineers
- Support production employees, inspection staff, and cell staff by evaluating, interpreting, and providing feedback regarding customer and company requirements and specifications
- Support and follow all rules/guidelines/standards set by EHS, Quality, and Continuous Improvement functions as set by leader and position
- Maintain Quality Management System (QMS) as directed by Quality Manager
- Maintain customer and industry specifications and system of revision control
- Assist in customer and third party audits. Manage follow-up to ensure satisfactory compliance
- Perform customer designated release function, as applicable
- Proficient computer skills (i.e. Microsoft Office Suite)
- Data-driven
- Energetic
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Associate Quality Analyst Resume Examples & Samples
- Must have extensive prior experience in Risk for Retail Bank or Default Services monitoring; (at least 3 years.)
- Experience in managing volume to productivity and quality standards; organizational skills
- Thorough knowledge of the QC/QA review process
- Robust awareness for the Federal Retail regulations required
- Display strong Analytical, problem-solving, and negotiating skills
- Must have excellent written and verbal communication skills; ability to communicate at all levels
33
Associate Quality Resume Examples & Samples
- Must be computer literate and communicate with email
- Must have high attention to detail
- Knowledge of Rx product a plus
- Ability to use common measurement equipment
- Ability to learn new procedures
- Knowledge of eyewear testing a plus
- Knowledge of international standards and use of sampling plans a plus
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Associate IT Testng & Quality Analyst Resume Examples & Samples
- Assists in performing quantitative and qualitative analysis of less complex data, identify gaps and communicating findings
- Assists in supporting software quality control and assurance activities by developing and maintaining less complex workflow templates and other best practice activities for the organization
- Assists in developing reporting solutions that provide project teams with critical metrics for effectively measuring and managing test deliverables and processes
- Assists in establishing less complex testing processes and guidelines for activities supported within the organization that can be leveraged across the enterprise
- Assists other team members
- Develop and implement less complex software process improvements and efficiencies related to test activities
- Collaborate with project teams to ensure that established quality goals are being incorporated into the business solution
- Presentation and facilitation skills
- Independent thinker and contributor
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Quality Developement Associate Resume Examples & Samples
- Assure the products meet and/or exceed the requirements specified by our internal and/or external customers including government regulations
- Ensure required information for products, policies and procedures are documented, updated, and available when requested
- Conduct analysis for data trends on raw material, work in process, and finished product. Analyze trends and/or process control opportunities and challenges
- Learn core-responsibilities in the ConAgra Performance System (CPS)
- Lead, Manage and execute plant Quality processes
- Create and lead an engaged team oriented workforce
- Coach plant resources in the implementation of the improvement methodology
- Support continuous improvement goals in safety, quality, cost and customer service
- Manage and owning various functions of the business and creating an engaged and team oriented work force in order to improve business results
- Manage production or quality staff to attain production and quality goals
- Identify problems or bottlenecks in production processes and resolves issues
- Ensure production resources including materials, equipment and human resources are available as needed to maintain production schedules
- Develop implementation plans and standards and/or leads the planning and implementation for one or more critical improvement processes
- Provide training and qualifies plant resources. Tracks implementation and qualified resources
- Bachelor’s degree in Food/Nutritional Sciences, Biological Sciences (Meat Science, Packaging, Microbiology, etc.), and / or Engineering (or other technical degrees), or related discipline. Candidates need to have a mechanical aptitude
- Overall GPA of 3.0 or above strongly preferred
- Desire to grow within the supply chain - quality function
- Knowledge of statistical process control
- Excellent interpersonal, written and verbal skills
- Proven leadership ability (i.e. collaboration, influencing & problem solving skills)
- Strong time management and follow-through skills
- Ability to react to day to day situations without losing sight of strategy
- Financial Aptitude (i.e. budget management, cost driver understanding)
- Ability to relocate within 18-24 months
- Ability to travel up to 20%
36
Associate Director External Site Quality Lead Resume Examples & Samples
- A minimum of eight (8) years of experience working in the Pharmaceutical industry, with strong knowledge of and broad experience in Quality Assurance and Quality Control activities, particularly applied to deviation management, as well as significant investigation and Fact Finding coordination
- Experience in Quality Agreement development and contract negotiation
- Familiarity with Field Alert Reporting is also required
- Must have strong knowledge of and broad experience in product Quality Assurance and Quality Control activities
- Prior experience managing 3rd Party relationships
- Demonstrated experience in quality risk management in the Pharmaceutical industry
- Strong demonstrated communication skills
- Demonstrated personal networking and relationship building skills
- Conversant on domestic and foreign regulations and compendia governing manufacturing operations
- Contractual and financial awareness is preferred
- Experience in Lean project implementation also preferred
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Trans Quality Assur Associate Resume Examples & Samples
- Will be responsible for reconciliation in back-end proprietary tools
- Will be responsible for data quality, control and oversight
- Design strategies and processes to improve data consolidation, and integrity through various data validations and quality measures
- Reduce recurring manual data calculations and collection through automation
- Implement process improvements to reduce production times and increase accuracy
- Create and maintain documentation for all data processes
- Analyze performance of reports/programs and take action to correct deficiencies
- Works with management in the resolution and documentation of client issues. Develops creative solutions, using technology
- Demonstrates effective, professional verbal and non-verbal communication skills
- Exhibits strong leadership and interpersonal communication skills
- Exhibits the ability to provide direction and support to staff in maintaining or exceeding quality benchmarks
- Highly motivated and able to work without supervision
- Fast and exact data collection skills
- Strong Microsoft Office skills (MS Excel and MS Word) with advanced Excel skills (for data analysis, quality checks and reconciliation etc.)
- The ability to effectively work as an individual contributor and possess strong analytical, problem solving, critical thinking and decision-making skills, multitask and deliver under tight deadlines
- A desire to work in a team environment and with multiple stakeholders
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Associate Quality Analyst Resume Examples & Samples
- Provides statistical data analysis, including but not limited to quality, financial, or production data using various data systems and business intelligence software (SAP, Tableau, spreadsheets, etc.)
- Reports findings to operations, quality, sales and marketing teams; creates an executive summary of results
- Analyzes large data set in Excel or Minitab to calculate process capability, standard deviation, mean, hypothesis testing, control charts, and graphical analysis
- Summarizes and interprets results for management to make data driven decisions for continuous improvement
- Conducts root cause analysis or develop a test plans to capture data
- Runs and monthly reports for key performance metrics in Quality performance
- Identifies any variances to goals with color indicators; present findings and makes recommendations
- Knowledge of analytical techniques and procedures. Effective use of reporting tools and personal computer software (spreadsheet, database, word processing, etc.)
- Demonstrated organization and prioritization skills; experience meeting deadlines while maintaining accuracy, quality and quantity of work performed
- Experience working independently under minimal supervision
- Bachelor’s degree in Accounting, Finance, or Statistics, Food Science, or Chemistry, Biology, or Engineering plus 2 years of quality assurance/quality management experience in a production/operations environment
- Demonstrated knowledge and understanding of SAP is preferred
- Experience effectively presenting information and responding to questions from groups of managers, clients, customers, and the general public
- Skilled in the use of MS Word, MS Excel, MS Access, and MS PowerPoint at a basic level
- Experience with LIMS
- Skilled in working with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
- Skilled in concepts such as fractions, percentages, ratios, and proportions to practical situations
- Experience solving practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Experience interpreting a variety of instructions furnished in written, oral, diagram, or schedule form
- Experience in the nut industry preferred
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Associate Transactional Service Quality Resume Examples & Samples
- Facilitates internal call monitoring, client and CSAT calibration sessions
- Completes and delivers Attainment, Calibration, and Variance reporting to Operations, Program Management and Training relative to team and program level results
- Audit evaluations completed by Team Leaders and/or Evaluators and provide direct feedback to the Team Leaders and/or Evaluators to ensure scoring accuracy
- Provides insight to Operations and Account Management relative to improvement opportunities
- Provides recognition to high performing teams and individuals’ relative improvement in the top two success drivers for the program
- Develops rapport and strong working relationships with internal operations and key management personnel
- Consults with Quality Management on process improvement, training, environment, Quality and CSAT tools and analysis, recommends and initiates appropriate change
- Bachelor's Degree in related field from a four-year college or university with less than two years of relevant experience preferred
- Proficient in Microsoft Office
- Subject matter expert for Quality related client interaction on site
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Associate Quality Analyst Resume Examples & Samples
- Works across all functional areas surrounding call centers, Technical Support, Customer Support, Sales, to ensure quality, customer service, and practices in support of the policies and procedures of the organization
- Monitors call center volumes and makes suggestions regarding production and scheduling
- Reviews calls and call center metrics to ensure that procedures are being followed and makes suggestions regarding training needs or performance enhancement offerings
- Looks for opportunities to improve servicing and quality of call center support
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Associate Quality Analyst Resume Examples & Samples
- This role will be primarily working within a facility in patient registration environment providing direct quality review / auditing support through performing concurrent quality reviews
- Has basic knowledge of theories, practices and procedures in a specific Optum360 revenue cycle function
- Some proficiency in understanding of upstream and downstream impacts to partners of business process operations and solutions
- 1+ years of Project Management experience
- Travel is required 25% of the time. Travel will often be required by car to facilities and overnight stay may be required
- Prior experience in large, multi-function and cross-geographic organizations
- Process Improvement experience (Six Sigma, Lean, TQM, etc)
- Prior experience in Patient Registration environment
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Associate Director, R&D Quality Resume Examples & Samples
- Lead risk based planning to strategically plan non-clinical audits and engage appropriate business partners
- Direct the assignment of audits
- Conduct assigned audits per the audit plan and engage partner input as appropriate
- Review audit reports and provide feedback to auditors
- Monitor for trends, quality, timeliness and consistency of deliverables
- Advise business partners on the development of effective corrective action plans and verification of implementation
- Develop and provide meaningful audit metrics and trending reports
- Lead the risk based planning of non-clinical inspection readiness programs
- Liaise with business partners to discuss the implications of relevant findings and/or share regulatory agency trends
- Interface with regulatory agencies
- Design, develop, and administrate training materials, SOPs, tools, etc
- Proven understanding of non-clinical processes and systems
- Demonstrated ability to lead/manage/coach a diverse team in a global organization
- Extensive knowledge of worldwide regulatory requirements
- Knowledge/understanding of the approach and perspectives of regulatory agencies
- Ability to ensure strategic risk focus and prioritize activities in response to the myriad of complex, inconsistent, and constantly evolving global regulations and expectations
- Excellent written and verbal communication skills including presentation skills
- Bachelor’s degree required, preferably in a health-related discipline, and scientific training
- Proven non-clinical FDA GLP knowledge (10 or more years’ experience) of working within a regulated GxP audit function
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Associate Quality Analyst Resume Examples & Samples
- At times depending on volume, complete loss analysis on files in CMAX when needed by auditing default mortgage claim filings to ensure compliance with investor, insurer and company guidelines. Break down the loss to Citi by itemizing each expense write off by controllable/non-controllable and balance loan to the penny to clear DRI claim receivable
- Identify supplemental opportunities & refer to claims for filing
- Request refunds to insurer/investor as needed. Approve wire transfers to insurer up to DOA amount
- Release loss entries to accounting following approval in CMAX ensuring DRI accounting module is cleared and closed appropriate DRI default module
- Complete secondary loss sheets as needed to clear items on the completed and receivable reports
- Monitor and track aging of inventory and re-allocate volume based on load balancing
- Monitor and update receivable and completed reports for the team
- Review disputed bill backs and assist with the preparation of rebuttals
- Escalate issues to the investor as needed
- Assist with investor/insurer audits
- Work with business partners or investor to resolve controllable errors identified in the analysis process
- Monitor past due tasks
- 3-5 years analytical experience
- MS Excel 2000/2003/2007 Proficiency Required (needed for formatting, charts, pivot tables, external linking, data reorganization and presentation
- MS PowerPoint Proficiency Recommended (needed for organizing presentable data from Excel)
- Exposure to SQL and VBA programming experiences recommended but not required
