Associate Quality Assurance Associate Resume Sample

4.6
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Freda Harber
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Work Experience


Associate Director of Quality Assurance
07/2017 - PRESENT
Chicago, IL
  • Project support and management (time management, exhibits initiative in collaborative problem solving)
  • Complete the step-by-step profile and attach your resume (either is acceptable, both are preferable)
  • Develop C/C++ unit and integration tests to validate driver and kernel-level software for Ford’s SYNC infotainment system
  • Months C/C++ software development experience on embedded, mobile, or consumer electronic platforms
  • Demonstrates the ability to successfully plan, adjust, manage and optimize all resources for advancement of all goals and objectives
  • Experience serving in a Quality Management role
  • Has an excellent understanding of operational GLP’s
Quality Assurance QAR Associate
01/2015 - 05/2017
Detroit, MI
  • Work to understand processes, identify failure points, and develop quality assurance / audit programs to ensure operational excellence is achieved
  • Determine appropriate action plans and obtain buy-in from functional areas on remediation activities and dates. Follow up to ensure timely execution of action plans
  • Maintains expert level GxP knowledge in at least one regulated discipline (AWP/GLP/GCP/GCLP/Non Regulated/PV/QMS/IT) with the ability to provide critical information, advice and guidance on complex quality and compliance issues
  • Develop automated test scripts for HMI testing in Python
  • Months of Python scripting development experience
  • Exercise independent judgment and decision making abilities required
  • Demonstrated knowledge of relevant regulations and guidances. (ie. cGMPs, SOPs, Protocols)
Associate Director, Audit Quality Assurance
05/2009 - 10/2014
San Francisco, CA
  • Demonstrated problem-detection and problem-resolution skills required
  • Facilitate conflict resolution and negotiation skills
  • Work closely with Product Development, Production, Fabric/Trim and Quality Assurance to ensure that all merchandise meets or exceed the brand’s and customers’ quality expectations
  • Conducts audits (protocol/plan, raw data, and final report audits for accuracy and completeness, verifying that the final reports accurately reflect the raw data generated) and in-lab critical phase inspections of any GLP-regulated study performed at the laboratory for conformance to the final protocol/plan, SOPs, and relevant GLP regulations
  • Conducts inspections of laboratories/facilities
  • Conducts audits of employee training files
  • Prepares written records of all inspections and audits. Submits findings to the study director,and/or principal investigator (or laboratory supervisor, when appropriate) and management, indicating deviations from or conformance with GLPs, protocol/plan, methods and SOPs

Education


Grand View University
2005 - 2009
Bachelor's Degree in Life Sciences

Professional Skills


  • Effective troubleshooting skills where leveraging research, analysis, and problem solving skills
  • Excellent organisational skills with demonstrative experience in managing teams and complex execution plans
  • Strong organizational, analytical and project management skills, including the ability to prioritize several projects at a time
  • Strong computer skills, particularly word processing, spreadsheet and data base software
  • Multi-task, be thorough and detail oriented, with strong job closure and analytical skills
  • Effective communication skills: written (including technical writing), oral, listening
  • Exceptional customer relationship and consensus building skills

How to write Associate Quality Assurance Associate Resume

Associate Quality Assurance Associate role is responsible for training, research, negotiation, telephony, finance, integration, architecture, reporting, manufacturing, design.
To write great resume for associate quality assurance associate job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Associate Quality Assurance Associate Resume

The section contact information is important in your associate quality assurance associate 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
  • Email
  • Telephone number

Work Experience in Your Associate Quality Assurance Associate Resume

The section work experience is an essential part of your associate quality assurance associate 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 assurance associate 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 assurance associate position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Associate Quality Assurance Associate resume experience can include:

  • Experience in a GMP parenteral manufacturing environment
  • Experience with regulatory filing requirements
  • Identifying, escalating, and reporting testing exceptions and themes for further review, root cause analysis and remediation
  • Communicating findings to management and assisting in developing action plans to facilitate timely escalation and resolution
  • Managing the India QA team focused on Corporate-led QA reviews, including data integrity testing of certain products
  • Executing data integrity testing on critical data elements (key data sources back to source documentation)

Education on an Associate Quality Assurance Associate Resume

Make sure to make education a priority on your associate quality assurance associate 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 assurance associate 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 Assurance Associate Resume

When listing skills on your associate quality assurance associate 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 assurance associate skills:

  • Strategic planning, leadership, and negotiation skills, and the ability to develop and present training materials to large groups
  • Relevant experience or equivalent combination of education and work experience
  • Assist with the transfer of knowledge of technical skills and is viewed as a Subject Matter Expert
  • Deal effectively across all levels of the firm’s extensive support structure
  • Interpersonal skills needed for collaboration, communication, and presentations
  • Coaching, mentoring experience

List of Typical Experience For an Associate Quality Assurance Associate Resume

1

Experience For Associate Director of Quality Assurance Resume

  • Strong knowledge of GMP regulations, guidance, and general compliance expectations
  • Detail oriented; solid analytical thinking and problem-solving abilities
  • Experience in a customer service role
  • Inbound call center or quality assurance experience
  • Experience in QA or QC, with focus on bioanalytical
  • Responsible for supporting incoming, in-process, and final inspections of electromechanical hardware
2

Experience For Quality Assurance QAR Associate Resume

  • Coordinate problem resolution with the engineering, manufacturing and program teams
  • Entry level Quality Assurance position working in an AS9100 environment
  • Think strategically across various content and material with limited training
  • Produce auditable working papers to support conclusions
  • Self motivated individual who is able to partner with stakeholder and identify opportunities for efficiently executing on deliverables
  • Where appropriate, implement Design of Experiments and Problem Analysis/Solving concepts in conjunction with R&D
  • Implement system to identify critical to quality characteristics and control them; implementation of control plans in our manufacturing processes
  • Updates the master schedule as required by GLPs
  • Temperaments/Mental Requirements - Frequently required to exercise judgment and make decisions. Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct
3

Experience For Associate Director Site Quality Assurance Resume

  • Attendance / Schedule - Attendance requirements are based on BIFI general attendance policies
  • Formulate and recommend Performance Improvement solutions, competency models, Change Management Strategies, and Engagement Strategies services/solutions
  • Ensure data integrity standards
  • Verify product conformance to program specifications, drawings and acceptance tests
  • Contribute to Material Review Board (MRB) activities, perform root cause analysis and participate in corrective action process
  • Capture inspection data and supplier data packages in VISUAL Quality Module
4

Experience For Associate Director, Audit Quality Assurance Resume

  • Work with Suppliers to resolve non-conformances and corrective actions
  • Interface with Customer QA representatives
  • Support Quality Management System (QMS), AS9100C and CMMI processes and perform audits
  • Create and review procedures & work instructions
  • Support assigned programs in accordance with detailed Quality Plans
  • Ensure calibrated equipment is calibrated in a timely manner
5

Experience For Quality Assurance Engineer Associate Resume

  • Assist the device history records group by reviewing documentation, ensuring compliance with GMP and company SOP’s, making sure projects are running within specifications
  • Provide a positive leadership example through the respectful, professional manner in which they coach and develop staff and in their interactions with all members of the team
  • Interact with peers and leadership
  • Work closely with Product Development, Production, Fabric/Trim, Technical Design and Quality Control to ensure that all merchandise meets or exceeds the brand and customer quality expectations
  • Responsible for all communication between Lilly Pulitzer® vendors/factories and 3rd party testing facilities. Develop and document testing charts and tracking reports to help maintain timing and approvals. Responsible for all payments regarding testing, ensuring invoices are accurate and paid on time
  • Conduct Data analysis, sampling plans and develop quality management tools to address operational issues and failures. Develop finished product specifications and AQL’s
  • Documentation of procedures, Standard Operating Procedures (SOP’s), tests and trials, process controls, and lessons learned in support of quality and food safety programs
  • Conduct evaluations against process and product specifications and AQL’s. Communicates key findings and results to quality network
  • Assist in accumulation of Key Performance Indicators (KPI’s) on quality processes; present data for analysis; report project status and deliverables
6

Experience For Associate, or, Quality Assurance Resume

  • Manage projects and systems
  • Troubleshoot systemic issues and develop solutions
  • Review and approve activities conducted by outside vendors that directly impact the quality of products manufactured at PPS, including: Calibrations, Equipment Qualifications
  • Ensure that deviations occurring during manufacturing are investigated and closed in a timely manner
  • Performs line clearances to ensure rooms have been adequately prepared for production runs
  • B.A. or B.S. in scientific field and/or equivalent
7

Experience For Quality Assurance Testing & Compliance Associate Resume

  • Knowledge of current trends with regards to ICH and US regulatory inspections and expectations. Also desirable: EU regulatory knowledge
  • Review discrepancies or newly discovered trends with Global QA Managers for proper disposition and potential amendments to procedures
  • Measures employee performance against set quality audit parameters for recorded and/or live calls
  • Participates as required in quality initiatives by requiring adherence to quality assurance policies and procedures; developing new models; implementing changes
  • Directs quality initiatives by requiring adherence to quality assurance policies and procedures; developing new models; implementing changes
  • Knowledge with mechanical drafting standards and techniques
  • Proficiency with bus interfaces including: USB, PCI, SDIO, and memory-mapped interface
8

Experience For Associate SHS Quality Assurance Resume

  • Provides documentation of corrective action taken related to system and application technical modification
  • Manages user and group privileges, definition of users and groups, analysis of users/groups hierarchies
  • Creates customized queries for end-user support
  • Work is performed in a climate-controlled call center environment
  • Occasional exposure to dust, electricity, and extreme temperatures
  • Knowledge of the multiple processes in the BPO space
  • In-depth knowledge of Tools/Software used for Transactions & Audit Process
9

Experience For Quality Assurance Call Associate Resume

  • Lean / Six Sigma Green or Black Belt Certification
  • Able to develop and apply quality test and inspection methods to turn materials into products
  • Work independently with minimal direct supervision in a fast paced environment
  • Develop solutions to issues of moderate complexity
  • Detail oriented to review & test various data elements
  • Work an assignment independently with minimal direct supervision
  • Development of the Risk Management files which includes Hazards Analysis, Design FMEA, Use FMEA & Process FMEA
10

Experience For Associate Director West Point Quality Assurance Resume

  • Develop, initiate, and implement new quality concepts, tools and strategies to improve business practices
  • Lead and mentor team of NPD Quality Engineers to ensure compliance and consistency across projects
  • Actively participate in and/or facilitate the development of deliverables required for medical device product development, specifically components that focus on design reviews, quality plans, design transfer, and design verification/validation
  • Ensure new and modified products/processes meet customer requirements and specifications
  • Ensure compliance to all design control requirements

List of Typical Skills For an Associate Quality Assurance Associate Resume

1

Skills For Associate Director of Quality Assurance Resume

  • Past experience in audit principals and/or testing and monitoring programs, reporting and analysis
  • Experience with Geometric Dimensioning and Tolerancing (GD&T) ANSI Y14.5m 1982 principles and complex coordinate systems
  • Significant experience in quality monitoring
  • Quality Assurance/Call Monitor or coaching experience
  • Demonstrated basic understanding of audit techniques
2

Skills For Quality Assurance QAR Associate Resume

  • Understanding of Merck’s Quality System
  • Understanding and savvy to implement Quality Assurance in an Academic cGMP setting
  • Develop and implement quality programs, including tracking, analyzing, reporting and problem solving
  • Assists Quality Management Services group in developing/reviewing test plans, relative to new implementations of voice recording and quality monitoring systems
  • Assists in reviewing, writing, and maintaining up-to-date SOPs and controlled documents for the QA unit
  • Coordinates daily and monthly staffing schedules, capacity planning and cross-training efforts
  • Assists senior QA management with identifying staffing needs and contributes to hiring decisions
3

Skills For Associate Director Site Quality Assurance Resume

  • Translating insights into innovative and viable ideas or solutions, uncovering unmet needs, leveraging diverse perspectives, background and talent to generate effective ideas, and adding significant value
  • Promoting a work environment that challenges the status quo, and leads and adapts to change, creating a significant positive change
  • Encouraging and supporting others to properly take and manage risks
  • Provides direction and influence relative to compliance issues and negotiates resolutions and next steps with business partners and management. Effectively communicates complex issues to Business Partners and management
  • High-level understanding of voice recording technologies
  • Provide training to Site personnel on departmental SOP’s, Quality Systems documents and Qualifying Events as related to QA
  • Interface with engineering, manufacturing, program office and configuration management
  • Conduct GMP investigations, including: Root Cause Analysis, Risk Assessment, Impact Evaluation and Technical Report Writing
4

Skills For Associate Director, Audit Quality Assurance Resume

  • Understands opportunities as per quality audit results to provide coaching and training inputs
  • Administers timekeeping functions via Alorica’s time reporting system
  • Make decisions independently regarding projects, programs, and initiatives within confines established by management
  • Manage project budgets, schedules, and resources; lead planning activities for assigned area
  • Oversee preparation of periodic financial and technical reports and operating plans
  • Coordinate and develop resource and testing plans for various types of releases and product enhancements
5

Skills For Quality Assurance Engineer Associate Resume

  • Clear understanding of agent administration in CMS
  • Responsible for completing required number of quality reviews for each agent based on client/company performance guidelines
  • Facilitate internal training programs to all audiences
  • Tape presentations as required for counseling sessions and client review
  • Review and approve controlled documents requiring QA approval signature
  • Assists with development of the call center training and QA process
  • Coordinates with Operations, IT, and Account Services to provides end user support and troubleshooting related to system and application issues
6

Skills For Associate, or, Quality Assurance Resume

  • Enforces rules related to the analysis, creation, and maintenance of customized call recording and interactions schedules
  • Provides problem analysis and resolution in support of existing applications and projects
  • Assists IT department in quality monitoring problem resolution
  • Clearly expresses opinions and new ideas in a clear, concise, well-structured and easily understandable way through a variety of media
  • Responsible to review, validate and analyze test reports to ensure all products adhere to government regulations and are in compliance with US requirements as well as Lilly Pulitzer® standards in all product categories
  • Accountable to implement, review and refine protocols and testing requirements to ensure Lilly Pulitzer® is meeting and exceeding government regulations and requirements
  • Obligated to maintain awareness of industry standards to ensure compliance, while meeting brand aesthetic
7

Skills For Quality Assurance Testing & Compliance Associate Resume

  • Responsible to ensure all legal documentation for all merchandise is organized, accounted for and properly recorded
  • Fully knowledgeable on all compliance requirements, federal and state regulations
  • Monitor and evaluate completion of tasks and projects. Oversee interdepartmental activities and efforts
  • Interface with customers to determine project requirements
  • Provide strategy and vision; make decisions that establish objectives for the overall direction or operation of a significant project(s) or area(s)
  • Manage staff of a large science, engineering, and/or technical research area, which includes recruiting, hiring, developing, evaluating and setting priorities; manage business, technical, and educational activities for direct reports including managers and technical experts
8

Skills For Associate SHS Quality Assurance Resume

  • Identify, clarify, and resolve issues with strategic impact and substantial significance, which spam multiple areas, using advanced technical and professional knowledge requiring broad discretion and judgment
  • Develop policies and procedures as they relate to academic or program activities
  • Implement, evaluate and maintain quality control standards to ensure program success
  • Establish, oversee and manage financials and schedule for large programs and/or multiple projects
  • Negotiate with internal departments and external agencies with authority to commit resources and effort
9

Skills For Quality Assurance Call Associate Resume

  • Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies
  • Roll up your sleeves and lead a team of Quality Assurance Engineers using cutting edge technologies like AngularJS, Frisby, Protractor, Selenium, jMeter and many others
  • Lead training initiatives and further evolve the QA training program to reflect the current demands of the Quality Assurance role
  • Provide critical feedback to analysts within the QA department and promote professional development
  • Work with Product Management to understand client workflows in relation to current capabilities of the , as well as the implementation of new functionality
  • 5-15% - (depending on plant location) Understand export documentation requirements and prepare documentation. Understand customer COA requirement and prepare COAs for customers as needed
  • Provide back-up assistance for QA Supervisor, Food Safety Specialist, or Microbiology Supervisor. Complete pre-shipment review and product clearances as needed. Effectively communicate QA and Micro results, including timely reporting of all quality assurance activities
10

Skills For Associate Director West Point Quality Assurance Resume

  • Maintain all manufacturing, safety, QA, Pre-requisite Programs (PRPs), and HACCP policies in production of products. Organize and maintain accurate and pertinent information to assure that processes and products are food safe
  • Knowledge of emerging technologies, trends, methodologies, and resource management principles
  • Assess for risk and provide solutions to meet performance requirements, while protecting design intent
  • Objectively evaluate performance against standards and to identify performance gaps and recommend
  • Synthesize and articulate technical and scientific methodologies, specifications, and information
  • Resolve complex issues quickly and make decisions that meet university objectives in a collaborative culture
  • Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds
  • Occasionally sit, use a telephone or write by hand

List of Typical Responsibilities For an Associate Quality Assurance Associate Resume

1

Responsibilities For Associate Director of Quality Assurance Resume

  • Assess changes though our Change Management Process to assure quality is maintained. This includes approval of temporary changes implemented to satisfy product supply requirements and assure permanent resolution
  • Experience or familiarity with working in a production environment (manufacturing, assembly, integration, test)
  • Industry experience in either Manufacturing or QA
  • Extensive experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.)
  • 6 months-5 years of experience working in a quality role in the life sciences
  • Expert knowledge and technical understanding of the manufacture of Cellular Therapeutics and testing
  • · Understanding of Merck’s Quality System
  • Function as a delegate of the Global Quality Director when not available
  • Implement a system to trend quality issues across platforms to assure issues are identified and resolved early in the process
2

Responsibilities For Quality Assurance QAR Associate Resume

  • Provide leadership to ensure the organization attracts, develops and retains the best talent management
  • Experience in Alzheimer’s disease clinical research trials. Knowledge of clinical trials components including statistics, study methodology, informed consent, eligibility, and adverse events. Demonstrated success and skill at researching, analyzing, and evaluating information for preparation of clinical research protocols
  • Advanced experience applying multidisciplinary scientific principles and practices to provide technical leadership and influence experimental design and coordinate laboratory activity
  • Extensive experience with Quality Assurance systems and processes
  • Experience in Quality Assurance/compliance
3

Responsibilities For Associate Director Site Quality Assurance Resume

  • Full knowledge of GMP/ ISO compliance and quality systems
  • Experience in the Pharmaceutical industry or a similar operating environment which includes experience in a management / leadership role in a Quality function
  • Demonstrated ability to meet client requirements based on recent, consistent call quality scores at meets or exceeds
  • Education experience
  • Computer literate in the Microsoft office Suite (Especially Excel, Word)
  • Understands process interdependencies
4

Responsibilities For Associate Director, Audit Quality Assurance Resume

  • Communicate complex statistical techniques and or solutions to a wide range of organization levels, sop floor partners and plant director
  • Familiarity of Alorica IT Business Processes
  • Responsible to make recommendations and provide proactive solutions to improve the company’s return rate
  • Update and document testing protocols and procedures for corporate and vendor use to ensure specifications with high quality products are met including fabric, trims and garments
  • Analyze customer feedback on Quality issues and provide corrective action plan
  • Assures that proper testing is communicated during the development process so that testing protocols and product quality goals are appropriate and understood internally and externally
  • Accountable to explain and clearly communicate test methods as well as standards and requirements to both internal and external groups
5

Responsibilities For Quality Assurance Engineer Associate Resume

  • Responsible to educate and discuss potential risk. Provide collaborative solutions to all internal and external partners during development and bulk stages of the product
  • Strong team leadership and teamwork demonstrated by creating a positive environment, meeting stakeholder expectations, keeping leadership informed of progress and issues
  • Experience in leading audit projects as regional head or work experiences within the quality assurance functions of global internal audit department
  • Manage inspection readiness activities and represent Takeda as a Pharmacovigilance quality subject matter expert during health authority inspections of the sponsor. Provides strategic direction to assure that responses are timely and appropriate to maintain Takeda’s good standing with regulatory agencies. Ensure that Pharmacovigilance inspection commitments are fulfilled on time

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