Associate Quality Resume Sample
Hettie Gerhold
8719 Kihn Spurs,
Philadelphia,
PA
+1 (555) 855 0773
Work Experience
Associate Quality Analyst
12/2016
-
PRESENT
Philadelphia, PA
- Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes
- Under the guidance of the vendor quality lead, provide support in the development of the MRL QA vendor audit plan pertaining to vendor services using formal risk assessment criteria aligned with MRL standards and regulatory requirements. Engage with the research business areas to obtain appropriate input to the plan and ensure that research business areas understand the strategy
- Independently implement the audit plan through execution of audit processes including audit scoping, audit conduct at vendor sites, and reporting of audit issues to MRL QA management and appropriate research business areas
- Engage in follow up activities related to audit outcomes including additional audit reviews/assessments, meetings with the research business areas and/or vendors, and identification of audit outcome metrics to be reported to the MRL vendor management function
- Involves engagement with research business areas as part of formal operational governance forums, input on vendor quality agreements, consultation on vendor qualification processes and other ad hoc issues related to quality, and investigative interactions with other quality organizations in the research business areas
- Evaluate vendor services for quality management systems, end-to-end operational data flow including data acquisition, data management, analysis, reporting, data transfers, and data reconciliation activities
- Build effective working relationships with key research business areas and vendor quality representatives
- Engages with business quality groups to assimilate protocol level events and activities impacted by vendor performance as part of serious quality investigations, quality trending, and quality oversight
Associate Director Quality
05/2013
-
07/2016
Houston, TX
- Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations, safety guidelines and company policies and procedures
- Contribute to the ongoing development of MRL QA operating standards, work instructions, and training materials to further develop competencies within the MRL QA Vendor group and any other MRL QA areas assisting in support of the vendor quality program
- %Populate and update press check /color okay schedule - working with Quality Director
- Establishes and leads business and functional and strategies / objectives
- Considered an expert in their functional knowledge and expertise to the business. Participates in a wide variety of business discussions and decisions for the development of new products, manufacturing strategies, and sustaining / post market activities
- Carries out Management responsibilities such as the hiring, job assignments, performance planning and talent development, salary actions, performance reviews, and termination recommendations
- Perform multiple tasks / large projects and to prioritize work load for function
Trans Quality Assur Associate
03/2009
-
12/2012
Detroit, MI
- Work in and to direct teams to obtain results
- Drive and manage Process Improvement projects using simple concepts of LEAN by partnering with LOB’s
- Experience in the financial services industry
- Investigate and analyze scope of defects as required. Documents defects found during QA inspections into a database and/or hand held data collection device on a defect tracking sheet. Routes forms to respective manager in a timely manner
- Author and maintain detailed Standard Operating Procedures defining Winchester’s Quality Systems
- Ensure the adherence to the standards of quality ruled by current cGMPs and the Company’s Quality Policies and site Standard Operating Procedures
- Quality monitoring, coaching agents and reporting on calls related to the First Data Online Banking product and other products as needed. Certify newly trained agents. Assist with training as needed. Attend listening sessions with various internal and external clients, summarizing calls and scoring
Education
Everest University - Orlando Campus
2003 - 2008
Bachelor's Degree in Accounting
Professional Skills
- Demonstrated excellent communication skills, including well-developed interpersonal skills and strong written communication skills
- Effective written and oral communication skills as well as strong interpersonal skills
- Excellent and experienced meeting and presentation skills (presents at Trade Shows / Conferences)
- Knowledge of and experience with technology tools to support the Quality function including excellent computer skills in Microsoft Suite environment
- Knowledge and experience in financial management, planning, and organizational skills
- Strong technical aptitude, organization, analysis, and problem solving skills
- Experience and skillset to work in a regulated environment as well as the importance of following procedures, cGMPs and EHS is highly desirable
How to write Associate Quality Resume
Associate Quality role is responsible for interpersonal, presentation, auditing, microsoft, credit, finance, training, database, procurement, security.
To write great resume for associate quality job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Associate Quality Resume
The section contact information is important in your associate quality resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Associate Quality Resume
The section work experience is an essential part of your associate quality resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous associate quality responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular associate quality position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Associate Quality resume experience can include:
- 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
- Quality monitoring, coaching agents and reporting on calls related to the Home Credit product. Certify newly trained agents. Assist with training as needed. Attend listening sessions with various internal and external clients, summarizing calls and scoring
- Ensure the plant(s)/functional quality organization is (are) designed and resourced to fulfill its obligations and to comply with applicable regulations and procedures
- Excellent written, verbal, and analytical skills are essential
- Excellent problem solving aptitude. Experience preparing problem solving documents such as 8D’s is highly desirable
- Proven leadership ability and experience building and maintaining positive relationships internally and externally
Education on an Associate Quality Resume
Make sure to make education a priority on your associate quality resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your associate quality experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Associate Quality Resume
When listing skills on your associate quality resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical associate quality skills:
- Good written and oral skills. Good relational and team skills, ability to work collaboratively with others to complete assignments
- Experience in Stability of biological products, writing skills, problem-solving, cross-functional collaboration
- Good accounting and finance skills along with the ability to analyze numbers
- Effectively / actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties
- PC proficiency with good MS Office Suite skills ( especially Excel, Power point, MS projects)
- Proven knowledge and experience in pharmaceutical I medical product validation procedures
List of Typical Experience For an Associate Quality Resume
1
Experience For Associate Quality Analyst Resume
- Detect defects and create informative bug reports and effectively follow up on bug closure
- Professional - Able to demonstrate unquestionable integrity, credibility and character. Has demonstrated high moral and ethical behavior
- Demonstrated ability to work independently and manage time efficiently and effective
- Continuous improvement leadership experience applying the elements of lean/operational excellence
- Accomplishes tasks through highly experienced professional specialists or manager
- Experience in the manufacture of biologic drug substance and drug product is desired specifically profusion and lyophilization processes is desired
- Experience at a manager level or above
- Specific knowledge and experience working with test automation tools and frameworks (Ex: Selenium)
- Keep the QA systems updated with relevant data and configurations to ensure effective test coverage
2
Experience For Associate Director Quality Resume
- Write effective test cases (manual and automated)
- Proven ability to lead, influence and manage people with diverse technical backgrounds within a matrix organization
- Demonstrated awareness of cultural differences and impacts of team/personal behavior
- Teaching Standardized Work and Work Combination Tables as a means of revealing waste and machine dependencies
- Replicating real business scenarios from various client perspectives to verify software correctness
- Leading Jishuken and Kaizen events for complex electro-mechanical devices
3
Experience For Trans Quality Assur Associate Resume
- Works with product development engineering and manufacturing engineering to
- Proficient in drawing process maps, writing report & creating scorecards
- Mentor and develop personnel, including dedicated succession planning and contingency management
- Performs incoming inspection activities, to assess conformance of products to the design as defined by the engineering drawings and/or supplier models
- Manage quality activities for the Miami manufacturing site and the Baltimore R&D center
- Continuously evaluate progress toward objectives adapting them to meet customer and business needs
4
Experience For Associate Advanced Quality Eng Resume
- Provides recognition to high performing teams and individuals’ relative improvement in the top two success drivers for the program
- Great team player, passionate about problem-solving, detail-oriented, with analytical approach
- Keep abreast of current methodologies, technologies, and tools, and proactively seek ways to incorporate them into testing efforts
- Software testing and/or software development
- Perceived as thought leader possessing subject matter expert knowledge of design controls
5
Experience For Quality Developement Associate Resume
- Promotes and initiates inter-team working across functional boundaries
- Ensures that product development projects and changes to existing products
- Partner closely with the Diagnostics Division to ensure products manufactured in Detroit and Baltimore meets AB requirements
- Ensure the plant/functional quality organization is organized and resourced to fulfill its obligations and to comply with applicable regulations and procedures
- Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by plant/business/function objectives
- Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendorsPerceived as thought leader possessing subject matter expert knowledge of global regulations
- Significantly contribute to development of local and/or global strategies
6
Experience For Associate Director, Quality Resume
- Serves on Leadership Teams such as ESC (Executive Steering Committee), Plant LT (Leadership Team), Extended Quality LTBuild an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies
- Assist AQE with any Launch related customer, internal and/or supplier quality corrective actions (8D’s)
- Prepares SQA documents supporting supplier qualification and certification to ensure material and supplier compliance throughout their lifecycle in accordance with directives and procedures
- Ensure handovers are documented properly and validate functionality quality based on provided documentation
- Participate in network teams to identify and resolve material compliance risks
- Perform quality assessment for supplier change notifications, BMS change controls, excipient materials, material certification and annual reviews including audit status
- Provide support as an investigational team member for supplier or material related non-conformance events. Responsibility includes completion of assigned action plan tasks
- Create, revise and maintain Quality Agreements for suppliers of materials and services used by the site
7
Experience For Associate Director, Aggregate Report Quality Resume
- Responsible for performing SAP, GDR, LIMS, Trackwise, DCA and other applicable system transactions relating to supplier qualification and certification activities
- Author and revise procedures for supplier qualification and certification programs
- Actively participate in and support inspection readiness activities
- Contribute to site improvement programs for supplier and material qualification/certification to meet evolving regulatory guidelines and to streamline processes
- Designing new functional test scenarios based on clients issues or support team requirements
8
Experience For Associate Director, R&D Quality Resume
- Assisting definition of specifications for Change Requests delivered by support team
- Act as CMC QA lead for pharmaceutical and combination product development projects
- Cooperation with developers, business analysts and product management teams to understand the business requirements and allocate the owner of reported issues
- Willingness to broaden financial knowledge (in particular payments, online security and online sales)
- Practical knowledge on software development lifecycle and methodologies
- Eligibility to work in multi-located organization
- Provides quality system methodology guidance, support and review for medical
9
Experience For Associate Quality Analyst, Optum Resume
- Plan, develop and execute software testing tasks for applications developed using various technologies including distributed Internet technologies (.net, relational databases, web services, etc.)
- Partner and build effective relationships with others throughout the quality and software development organizations
- Analyze business requirement specifications and interact with QA testing team to plan and develop test cases
- Update test cases when appropriate to reflect changes in product functionality or requirements
- Develop, execute, and support automated tests
10
Experience For Associate Director, Biologics Quality Resume
- Manage Quality Engineers on multiple projects and/or subsystems of projects
- Ensure the team’s quality representatives are capable and resourced to fulfill their obligations and to comply with applicable regulations and procedures
- Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by platform/business/function objectives
- Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors
- Build an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies
List of Typical Skills For an Associate Quality Resume
1
Skills For Associate Quality Analyst Resume
- Very strong verbal communication, negotiation and presentation skills
- Strategic thinking, analytical problem solving and decision making skills
- Experience in closing CAPAs and conducting CAPA effectiveness checks
- QA experience. Experience working in a team environment. Knowledge of computer software and systems within their respective environments
- Proven ability or project management experience in developing systems and processes to improve overall efficiency and productivity
2
Skills For Associate Director Quality Resume
- Strong leadership experience and abilities, having successfully managed Quality operations in a pharmaceutical, food, cosmetic or related industry
- Proven non-clinical FDA GLP knowledge (10 or more years’ experience) of working within a regulated GxP audit function
- Related work experience in IT, QA compliance, manual software testing and/or equivalent combination of education and experience
- Effectively contribute and implement new ideas to improve the software testing process
- Demonstrated ability to perform multiple tasks / large projects and to prioritize work load for function
- Prior experience in large, multi - function and cross geographic organizations
- Supervisory skills with ability to manage and develop teams, and manage multiple projects
- Effectively partner with R&D to troubleshoot technical issues
- Effectively navigate and lead through the challenges of change and establish global stakeholder engagement focused on win-win solutions
3
Skills For Trans Quality Assur Associate Resume
- Experience in developing, reviewing and approving cGMP related documents (batch records, SOPs, protocols, reports, etc.)
- Experience in reviewing investigations, evaluating root cause and corrective action plans
- Experience in overseeing and managing CMO performance
- Experience in developing dashboards and reporting KPIs
- Actively participate in planning, estimation, and prioritization processes to ensure successful execution of testing activities
- Specific programming language knowledge with strong coding knowledge (Ex: Java / C#)
- Can create MicroStrategy dashboards, reports and applications with the purpose of testing the end-to-end customer experience
4
Skills For Associate Advanced Quality Eng Resume
- Review documentation and provide comprehensive feedback on how to improve the quality and customer experience of working with this knowledge asset
- Specific knowledge and experience working with web services and APIs
- Experience working in a production oriented, deadline driven environment
- Previous experience in providing sound justification and explanation to representatives from health authorities / regulatory agencies is desirable
- Previous experience working in EPA, FDA, or Pharmaceutical environment
- Experience participating in Health Authority inspections
- Experience in writing responses to Health Authority observations
- Experience with hosting Health Authority inspections and/or Divisional audits
5
Skills For Quality Developement Associate Resume
- Quality experience in contract manufacturing is desirable
- Ensure effective design transfer between development and manufacturing
- Specific knowledge and experience working with relational databases
- Track and maintain accurate data in reporting tools. Identify & validate errors and ensure accuracy of reporting
- Proven ability to design, implement, and train employee son key quality system elements
- Experience in management and in quality assurance
- Strong Knowledge of the Quality Systems
- Experience with Work Flows, Databases, TrackWise and SAP
- Significant progressive management experience; preferably in the pharmaceutical industry
6
Skills For Associate Director, Quality Resume
- Significant experience in a quality role within a Pharmaceutical/Medical Device organisation
- Extensive knowledge of the international drug GMP’s and experience with European regulatory authorities
- Proven ability to work in and to direct teams to obtain results
- Graduate with 2-4 years of relevant experience
- Work on multiple projects with multiple priorities and ability to thrive in a fast-paced, complex, global, and dynamic environment
- Experience as an auditor or inspector of pharmaceuticals in a GMP environment
- Excellent knowledge of 21 CFR 210, 211 and Part 11
- Experience with regulatory agencies and inspections
7
Skills For Associate Director, Aggregate Report Quality Resume
- Experienced management of direct reports and department responsibilities
- Ensure effective technology transfer between Tuas, Baltimore and Miami
- Developing training programs for teaching principles of lean manufacturing
- Recording, analyzing and distributing statistical information about the MicroStrategy product
- Executing the check by running appropriate tools and also doing part of the check manually
- Communicating status, findings and progress highlighting blocking issues
- Improving production smoothing (Heijunka) in complex manufacturing environments
- Training practical problem solving techniques (PDCA cycle, A3 reporting style)
- Sitting, standing, walking
8
Skills For Associate Director, R&D Quality Resume
- Executing Product Holds for Non-Conforming Product
- Developing and Administering Product Dispositions
- Executing Material, Equipment, Process, and Product Testing Protocols
- Understanding of core Business Intelligence/ Data warehousing technology: RDBMS, Web, Client/ Server, OLAP, etc
- Specifying quality requirements of the MicroStrategy product
9
Skills For Associate Quality Analyst, Optum Resume
- Monitoring performance, scalability, and reliability of the MicroStrategy product
- Supporting trainings and exams
- Drawing samples from references available for the topic to be investigated
- Executing Material Floor Complaint Investigations
- Investigating Product Impact from Test Station Calibration Errors
- Executing Calibration Standards Replacement Process
10
Skills For Associate Director, Biologics Quality Resume
- Executing Module Quality Inspections
- Willing to work in shifts, flexible and highly analytical
- Working knowledge of the software development life-cycle
- Working knowledge in US and OUS quality systems and regulatory expectations required
- Working knowledge of FDA and EMA GXP regulations and ICH guidance documents
- Working internally with all related teams within Finastra to ensure that deliveries fully conform to expectations
- Deploying Hoshin Kanri as a means to move organizations to a new level of performance
- Applying principles of Jidoka to improve quality
- Using statistical process control to reduce variability
List of Typical Responsibilities For an Associate Quality Resume
1
Responsibilities For Associate Quality Analyst Resume
- Solving problems (production quality, productivity, cost) using Pareto Diagrams, Cause and effect analysis charts, graphs, Check Sheets, Histograms, Scatter diagrams, Control charts)
- Have at least 12 years experience in bio-pharmaceutical and/or pharmaceutical industry with at least 5 years in Quality
- Experience in the manufacture of biologic and/or pharmaceutical drug substance and/or drug product is desired
- Experience in the field or in a related area. Has knowledge of commonly-used concepts, practices, and procedures within a particular field
- Related quality assurance experience
- Effective interaction with all contacts and the ability to work in a team based environment and interact well with other employees at various levels
- Interest in keeping abreast of current trends in software development and testing, especially as they relate to the technologies being used
- Be proactive about testing, test coverage, and resolving issues
- Facilitate the evaluation of ECIs, including assessment, investigation, containment, review, approval and determination of on-going needs
2
Responsibilities For Associate Director Quality Resume
- Knowledge and understanding of FDA, EU and ICH regulations and guidance including cGMPs,
- Knowledge and proficiency in interpreting and applying GMP regulatory requirements and
- Create test reports detailing all bugs and issues found in each test iteration
- Specific knowledge and understanding of internet protocols and web technologies
- Some proficiency in understanding of basic process management and total quality management principles and methodologies (e.g. Six, Sigma, Lean)
- Provide support in the reporting and execution of field actions
- Basic understanding of relevant operational process area (Quality standards & Methodologies, Healthcare Business process services)
3
Responsibilities For Trans Quality Assur Associate Resume
- At least 6 months - 2 years of software testing and/or software development
- Knowledge of any automated testing tools (e.g., HP Quality Center, Quick Test Professional)
- Knowledge of electronic systems including: SAP, GDR, LIMS, TrackWise, DCA, and Microsoft Office Suite is highly desirable
- Work independently and make sound judgments in assuring compliance with regulations under tight timelines
- Create dashboards, reports, and applications using MicroStrategy
- Basic understanding of Sequel Query Language (SQL)
4
Responsibilities For Associate Advanced Quality Eng Resume
- Work with team members such as Tech. Lead QA, Senior QAs, QAs, Software Developers, PMs to ensure high quality outcome of all test deliverables
- Participate in daily stand-ups, iteration meetings
- Create, maintain, and execute tests – both manually and automated
- Report deviations of quality to the development team
- Work with software developers and discuss technical issues in detail
- Understand business requirements and translate them in to test cases
5
Responsibilities For Quality Developement Associate Resume
- Basic understanding of relevant organizations operations, products and applications, strategies, processes, and / or business priorities in order to build effective solutions
- 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
- 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
- Define, develop and maintain company procedures and processes for ECI handling and processing
- Subject matter expert (SME) and point of contact for Quality Complaint Team activities
- Analyze complaint data, gather additional data as needed, and partner cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolve complaints
- Ensure Regulatory report needs are maintained and timelines met (from ECI and Complaint Files perspective)
- Oversee, manage and provide input and feedback for Post Market Surveillance activities
- Ensure ECI investigations are robust & defendable
6
Responsibilities For Associate Director, Quality Resume
- Provide input and feedback to Customer Solutions (CS) complaint activities
- Develop and implement departmental process and cost efficiencies
- Provide management with status updates on assigned responsibilities and goals and timely escalation of issues
- Prepares Executive Quality Review Board (EQRB) presentations and coordinates data collection/analysis
- Actively support defense of notified body audits
- Be intimately familiar with cGMP, ICH and other quality guidelines and standards and ability to interpret and apply them
7
Responsibilities For Associate Director, Aggregate Report Quality Resume
- Fluency in English is required and fluency in Korea is desired
- Travel 25% of the time both domestically and internationally
- Basic knowledge of any one of the Quality Assurance Models (ISO 9001, 27001, Six Sigma & Lean techniques)
- Work proactively and collaboratively as part of a team on a large project
- Pay attention to details and to follow through on commitments
- 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
- Classify errors based on the type of the error and can assign root causes for errors
- Perform ATA & Detect Errors
- Classify errors based on type, can perform root cause analysis and documentation of CAPA
8
Responsibilities For Associate Director, R&D Quality Resume
- Knowledge of lean manufacturing/operational excellence principles or ability to obtain this skillset through participation as a change agent for continuous improvement is desired
- Strong technical, problem solving, and statistics background
- Experience with the software tools and techniques used in automated testing
- Experience in either Supply chain management or Supplier Quality
- BS/BA in relevant area
- Experience in Quality or Industrial Engineering working in a Fabrication Shop, for an Equipment Supplier or a Custom Manufacturing Environment required
- Among others, an online learning platform (1500 courses & 11000 e-books) as well as live speeches from software development gurus, like Uncle Bob
9
Responsibilities For Associate Quality Analyst, Optum Resume
- QSR/cGMP knowledge, auditing experience, experience with design of experiments, six-sigma certification, and knowledge of lean manufacturing techniques are desirable
- HIM / Patient Access experience
- International relocation package and professional support (if applicable)
- Assess compliance of clinical investigator sites and vendors with ICH, government agency regulations/guidelines, as well as EMD Serono policies, procedures and study protocols
- Establish and maintain processes and tools for the preparation, conduct, reporting and follow-up of GCP and GCLP audits
- Conduct audits of clinical laboratories (central lab, PK, Biomarker/CDx) and investigational sites
- Maintain high level of awareness, expertise in international and local applicable regulations and provide input into the development of internal R&D procedures
- Assist with regulatory inspections or corporate audit activities and external audits (e.g. by business partners) at EMD Serono Biopharma R&D sponsored or managed activities
10
Responsibilities For Associate Director, Biologics Quality Resume
- Investigates alleged cases of scientific misconduct or fraud
- Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance and wide range of auditing skills covering a broad range of areas and/or specialized auditing skills in multiple disciplines - including those related to Risk Based Quality Assurance and Data Integrity
- Competence in use of Microsoft Word and Excel. SQL query skills are required
- HIM/Patient Access experience
- Create effective test plans
- Intermediate knowledge of Microsoft Office Software (Excel, Word)
- Nice to have knowledge in digital roadmap databases and related tools (raw database and related tools, GDF viewer, ArcGIS); (optional)
- Repetitive (Use of Arm, Hands, Wrists – computer work)
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