Quality Associate Resume Sample

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Juana Cummings
361 Bennett Inlet,  Detroit, MI
+1 (555) 429 8413

Work Experience

Quality Associate
10/2016 - PRESENT
Chicago, IL
  • Writes, reviews and revises SOP’s as needed to assure compliance and continuous improvement
  • Assess product complaint information, designate an appropriate complaint level, and assign suitable complaint and/or analysis category(ies)
  • Determine the need for additional investigation and forward product complaint records and/or complaint sample to the proper manufacturing or packaging quality unit for further investigation, as required
  • Determine the need for the product complaint sample and perform product complaint sample retrieval actions per local procedures
  • Perform and/or verify results of visual and/or functional analysis of returned complaint samples per local procedures
  • Assess product complaint information and the results of the returned complaint sample, including impact on: complaint level; complaint category(ies); investigating site; and additional investigation requirements
  • Respond to the customer with educational information, as applicable, during customer follow up endeavors (e.g., request for batch number and/or product complaint sample)
  • Apply cGMP and cGLP principles in all phases of the product complaint investigation (e.g., data documentation)
  • Build and maintain working relationships with The Lilly Answers Center, manufacturing/packaging sites, and other affiliates associated with the Americas Regional Center
Senior Quality Associate
08/2010 - 09/2016
Philadelphia, PA
  • Participate in new product design and pre-launch preparation projects to identify and address potential customer product complaints
  • Contribute to post-launch product complaint monitoring activities
  • Serve as a subject matter expert (SME) for applicable CPQA-ARC procedures and work instructions
  • Participate in departmental process improvement activities
  • Report regularly on your team’s testing and QA activities (Sprint Reviews, Q-Gates etc)
  • Corrective Action Preventive Action (CAPA) / Nonconformance Management (CAPA Records)
  • Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate and timely manner
R&D Quality Associate
09/2003 - 06/2010
Los Angeles, CA
  • Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
  • Provide guidance and coaching for the areas of responsibility as defined in items # 1 through #5 for less experienced individuals within the plant
  • Assists with vendor audits/assessments and provides ongoing feedback related to quality issues
  • Develops competence by performing applicable work assignments
  • Builds own team effectiveness skills and promotes team effectiveness through own actions by demonstrating respect and appreciation for diverse perspectives
  • Execute review of electronic Master Batch Records (eMBR’s) utilizing reduced content review of critical steps and parameters as applicable
  • Supervise and assign activities to ensure alignment with the Malvern Site Vision


National University - Fresno Campus
1997 - 2002
Bachelor's Degree in Science

Professional Skills

  • Demonstrate strong communication skills (written and verbal) and presentation skills
  • Strong project management skills Strong organizational skills
  • Written and oral communications skills including strong presentation skills
  • Strong leadership and project management skills with demonstrated success in managing multifunctional global teams
  • Strong negotiator with excellent communication skills
  • Effective presentation skills and group facilitation skills
  • Strong analytical skills and process orientation Ability to work effectively with all levels of the organization

How to write Quality Associate Resume

Quality Associate role is responsible for analytical, organizational, interpersonal, training, word, basic, programming, java, facilitation, english.
To write great resume for quality associate job, your resume must include:

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

Contact Information For Quality Associate Resume

The section contact information is important in your quality 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 Quality Associate Resume

The section work experience is an essential part of your quality 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 quality 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 quality associate position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Quality Associate resume experience can include:

  • Have excellent communication skills, problem resolution and reporting skills
  • Good interpersonal, communication, influencing, negotiation skills
  • Strong programming skills of Excel Macros & VBA
  • Demonstrated proficiency in analytical and problem solving skills
  • Good Reasoning, Analytical and communication skills
  • Strong training skills with ability to become a certified trainer

Education on a Quality Associate Resume

Make sure to make education a priority on your quality associate resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality 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 Quality Associate Resume

When listing skills on your quality 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 quality associate skills:

  • Effectively assess the skills of new and existing staff to identify gaps and recommend training to address those gaps
  • Work with little supervision and demonstrate good decision making skills
  • Excellent JAVA programming skills (or a related programming language)
  • Demonstrated computing skills, specifically using Microsoft Office Applications
  • Have good critical thinking and problem solving skills

List of Typical Experience For a Quality Associate Resume


Experience For Senior Quality Associate Resume

  • Have strong knowledge of FDA Regulations and Application of Good Manufacturing Practices
  • Providing effective QA Introduction Training, ISO 13485 intro training and SOP trainings to new employees under EMEA QMS
  • Strong understanding of First Article Inspection and processes
  • Provides mentoring and leadership to less experienced staff
  • Knowledge about cGMP and KGMP (Korea Good Manufacturing Practice)
  • Experience in various quality systems and performing associated audits

Experience For Quality Associate Manager / Manager Resume

  • Experience in implementing quality systems
  • Experience in the area of Quality Assessment/Auditing
  • Experience in automated device assembly processes and sterilization of medical devices, including Vaporized Hydrogen Peroxide (VHP) sterilization methods
  • Experience with Quality auditing
  • Knowledge and application of Good Manufacturing Practices (GMP)
  • Knowledge and application of Good Manufacturing Practices GMP
  • Previous experience in managing Documentation life cycle
  • Experience in Quality Engineering or related field

Experience For R&D Quality Associate Resume

  • Good Team player, independent and adept at multi-tasking
  • Experience in conducting internal, external, and supplier audits
  • Assists and writes validations, audits and assessments, where needed
  • Hands–on experience in automation esp. jUnit, API automation frameworks
  • Demonstrated ability to debug issues in large cloud deployments

Experience For Quality Associate Intern Resume

  • Identifies and implements metrics to evaluate the effectiveness of process improvements
  • Experience in Quality, Operations, or related field in the healthcare industry. BS in science or related field is desired
  • Following up on action items with cross-functional teams, summarizing findings and recording information in detail
  • Supporting and monitoring metrics for certain quality related processes (change control, training)
  • Monitoring site implementation of the Quality System requirements, and provide mentoring, assistance and training to process representatives
  • Controlling further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected

Experience For Night Shift Quality Associate Resume

  • Initiating, recommending, or providing solutions through designated channels
  • Identifying and recording any problems relating to the product, process and quality system
  • Reviewing and approving the corrective and preventive actions (CAPA) arising from internal/external audits
  • Monitoring and reporting of quality activity ensuring management is informed in a timely manner of changes/trends that could affect our quality system
  • Checking implementation and maintenance of quality systems in CMO manufacturing facility
  • Working knowledge of statistical tools associated with receiving/inspection processes

Experience For Quality Associate Specialist Resume

  • Performing internal audits and supplier assessments according to the internal audit program
  • Supporting preparation to external audits, assist Mgr. Quality Assurance EMEA during external audits
  • Supporting on set-up and monitoring of trainings for EMEA regions
  • Following-up and monitoring of Calibration schedules within EMEA to ensure required devices are timely calibrated
  • Supporting quality control processes within EMEA QMS: CAPA, Change Control, Risk Management, Deviation handling, Supplier assessment and evaluation, etc
  • Monitoring and following up on timely submission and completion of corrective actions to Audit observations in EMEA

Experience For Senior CMO Quality Associate Resume

  • Auditing forms and reports for compliance while identifying areas that need improvement
  • Developing and / or revising Quality System process procedures to incorporate appropriate regulatory and corporate requirements
  • Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system
  • Providing GCP training to R&D employees
  • Operating on shop floor, Gemba Walks
  • Assisting the Quality Manager with the Company’s quality programs to ensure that TGA, Corporate and Catalent quality and GMP requirements are met

Experience For Catalog Quality Associate, Chinese Resume

  • Operating on shop floor
  • Partnering with identified areas of the business
  • Taking ownership in specific QMS continuous improvement projects as assigned and agreed with line manager
  • Ensuring Quality SharePoint remains up to date
  • Supporting in development, follow-up and implementation of Quality Plans
  • Working proficiency in English language
  • Training documentation process in ISO Train
  • Monitoring the quality standard activity and ensure Management is informed in a timely manner of changes/trends that could affect our Quality System
  • Verifying the implementation of solutions

Experience For Development Quality Associate Resume

  • Ensuring compliance to RB quality policies and procedures and to international standards of GCP
  • Completing risk assessments on vendor management activities
  • Assisting in the investigation and resolution of system deviations and clinical trial breaches
  • Inspect and measure incoming materials and components using calibrated measuring instruments
  • Provides administrative work maintaining and entering data into online and offline databases & tracking spreadsheets for several quality systems

Experience For Operational Quality Associate Resume

  • Assist in maintaining the calibration of testing and measuring equipment
  • Knowledge of software and its uses in generating reports, capturing data, and presenting data in an understandable format
  • Establishes a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices
  • Support daily and ongoing Field Service activities while assisting other areas in the successful performance of these activities
  • Applies thorough understanding of cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate
  • Provide training for SOP revisions and cGMP in accordance with training plans

List of Typical Skills For a Quality Associate Resume


Skills For Senior Quality Associate Resume

  • Strong interpersonal skills, Excellent communication skills; both written and verbal
  • Effective coaching, counseling, and communication skills are essential
  • Strong mathematical skills including plane geometry and trigonometry
  • Good knowledge of FDA Regulations, well-versed in application of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
  • Good problem solving, quantitative and conflict resolution skills
  • Excellent data analysis, interpretative and reporting skills
  • Have strong knowledge of FDA Regulations, Application of Good laboratory Practices, and Application of Good Manufacturing Practices
  • Strong word processing and spreadsheet skills which are essential
  • Demonstrated ability to multi-task and prioritize while providing excellent customer servic

Skills For Quality Associate Manager / Manager Resume

  • PC skills and a solid working knowledge of Microsoft Office software (Excel, Word and PowerPoint)
  • Good leadership, motivational and interpersonal skills
  • Excellent organization skills and ability to handle multiple tasks
  • Possess good communication & interpersonal skills1700171154W
  • Strong organizational skills and ability to plan and suggest resolutions to technical or resource problems
  • Individual with excellent problem solving skills and significant attention to detail

Skills For R&D Quality Associate Resume

  • Intermediate level communication skills with the ability to obtain, clarify, or give factual information. Good attention to detail
  • Excellent interpersonal and communications skills; exceptional attention to detail
  • Excellent oral, written, presentation, and organizational skills, with the ability to handle a wide variety of tasks simultaneously with limited guidance
  • Detail oriented, demonstrated ability to meet deadlines, and effectively handle sensitive, confidential information on a regular basis
  • Performing environmental monitoring, swabbing to validate the effectiveness of sanitation program
  • Working knowledge of FDA Regulations(211, 820), Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
  • Working knowledge of FDA Regulations & ISO 13485, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
  • Demonstrates strong abilities in leadership, guiding and coaching people and encouraging teamwork for supervisor-level employees and below
  • Plan and co-ordinate own workload in a high pressure environment to meet tight deadlines, by multi-tasking and utilising problem-solving skills

Skills For Quality Associate Intern Resume

  • Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership
  • Demonstrate effectiveness in task completion, decision-making, empowerment ofothers, exception management, training, problem solving and team leadership
  • Have proven experience in the area of Quality Assessment/Auditing and implementing and maintaining quality systems
  • Good understanding of and experience working with GMP or similar quality management systems
  • Strong knowledge and experience as root cause investigation owner, including use of DMAIC tools
  • Possess relevant laboratory/technical, writing, and computer skills

Skills For Night Shift Quality Associate Resume

  • Relationship building skills (internal and external)
  • Demonstrated business acumen with a proven track record of accomplishments for developing quality systems that are contemporary with industry best practices
  • Experience in Pharma or Medical Device Quality Systems, including operational experience
  • Related experience or product and process experience in manufacturing environment
  • Communicate effectively verbally and in writing with management, operators, process technicians and other inspectors about quality related concerns required
  • Effectively manage change, variables, and "gray" areas
  • The ability to manage risk effectively
  • Computer skills – MS Office, Databases, product and processes management systems (JD Edwards One World would be an advantage)
  • ​Experience in CAPA management, Change Management and Validation

Skills For Quality Associate Specialist Resume

  • Deal confidently and effectively with government agencies as well as internal and external customers at all levels of the organization
  • Strong administration experience required
  • Suggests revisions to procedures to clearly and effectively document processes
  • Strong team player with good problem solving abilities
  • Knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate
  • Work effectively in a highly matrixed environment
  • Exceptional facilitation / presentation skills

Skills For Senior CMO Quality Associate Resume

  • Understanding of Software engineering concepts with hands on experience in any OOPs language and scripting languages
  • Understanding of medical device regulations, manufacturing operations and Good Manufacturing Practices (GMPs)
  • Maintaining an excellent working knowledge of GCP , ISO 14155 and 13485 standards and regulations
  • Understanding and experience in GxP Pharmaceutical manufacturing industry is desirable
  • Working knowledge of FDA Regulations and application of Good Manufacturing Practice
  • Training/experience in statistical tools, including lean and six sigma concepts
  • Working knowledge of, and effective interpretation and application of Quality Systems regulations and ISO requirements
  • Training in GAMP or other ISPE validation courses

Skills For Catalog Quality Associate, Chinese Resume

  • Sound Hands on experience in designing and developing Test Automation using any of the automation test tools like Ecatt, Selenium, UFT etc
  • Fluent Korean and English communication (reading, writing and speaking skill)
  • Relevant experience in quality assurance in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA
  • Strong understanding of critical laboratory, manufacturing and facility processes
  • Relevant experience in Testing and Quality Engineering
  • Experience in applying automation and manual testing techniques

Skills For Development Quality Associate Resume

  • Relevant experience in quality assurance in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA
  • Passion for agile software engineering (Scrum, XP, TDD etc.) Project experience with automated testing. High capability to adapt to new situations / challenges
  • Experience with SAP is highly desired, including SAP or other software implementation and testing
  • Experience writing and managing SOP’s and Quality Assurance and Business Policies
  • Operate complex measurement instruments and determine proper measurement methods when developing/performing inspections to specifications
  • 6 months to 3 years experience in software Development/ Quality Assurance/Testing especially in White box/ black box /performance testing

Skills For Operational Quality Associate Resume

  • Experience in auditing techniques, interpreting regulations and quality system
  • Experience with SAP customer like testing
  • Experience working with VBA
  • Results oriented, entrepreneurial and self-motivated, with solid planning and organisational capabilities
  • To prepare and present review of the company’s QMS to ensure it’ continued suitability, adequacy and effectiveness in conducting clinical trials
  • Relevant industry experience working in a quality assurance group
  • Industry experience working in a quality group

List of Typical Responsibilities For a Quality Associate Resume


Responsibilities For Senior Quality Associate Resume

  • To liaise effectively within internal and external functions and provides expert guidance on validation topics
  • Strong interpersonal, organisational and analytical skills
  • Good PC skills, preferably MS Office
  • Develop, maintain and operate tools which enable effective and efficient testing of business processes
  • Effectively communicate with a wide variety of internal and external customers.
  • Strong experience with MS Word, Excel, Power Point and related database management software
  • Learn and apply new information and skills

Responsibilities For Quality Associate Manager / Manager Resume

  • Analytical, math, data management skills
  • Computer skills (Word Excel and PowerPoint) required
  • Work effectively independently and as a team member when required
  • Present information effectively in one-on-one and small group situations
  • Demonstrate ability in selecting, interviewing, training, coaching, motivate, discipline, and directing people
  • Exercise good judgement in implementing change orders that affect pricing, costs, and manufacturing processes
  • Develop and administer effective data collection and reporting system to meet regulatory requirements and management information needs
  • Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements
  • Software engineering or related experience

Responsibilities For R&D Quality Associate Resume

  • Good knowledge and understanding of GMP and application of pharmaceutical
  • Experience managing records throughout lifecycle/archive
  • Adaptable to changing priorities and needs
  • Approval and improvement of GMP related SOPs, Batch Manufacturing Records and validation documents
  • Colour matching experience
  • Strong working knowledge of Managed Care and Health Insurance concepts and regulations

Responsibilities For Quality Associate Intern Resume

  • Experience in IT, Engineering or related field
  • Relevant experience in a manufacturing environment
  • Experience in electronic document and learning management systems and relevant database use and management
  • Experience in dealing with representatives from Food and Drug Administration or other regulatory agencies
  • Experience in pharmaceutical industries
  • Focused on maintenance of effectiveness of processes
  • Review and approval of the validation protocol for all the temperature distribution study conducted in the distributor’s sites
  • Experience in medical devices, or Vaporized Hydrogen Peroxide (VHP) sterilization methods
  • Ensures that the site has a comprehensive Validation Master Plan and that it is properly maintained and followed

Responsibilities For Night Shift Quality Associate Resume

  • Follow up of identified validation deviations and escalation to QA management
  • Interface with Quality Assurance and IT partners to ensure that validation practices are aligned with regulatory expectations and best practices
  • Previous experience in Pharmaceuticals industry
  • Experience in a Quality Assurance position highly regarded
  • Determines the logic, adequacy and effectiveness of processes, systems and related requirements

Responsibilities For Quality Associate Specialist Resume

  • Good in both English and Korean
  • Assist with finished goods mock recalls based on business risk and volume
  • Experience in a lab environment
  • Work experience required, preferably in Regulatory Affairs, Regulatory Compliance, or a Post Market Surveillance area
  • Quality experience in a managed care environment

Responsibilities For Senior CMO Quality Associate Resume

  • Manage their own time and job priorities with minimal hour-to-hour supervision (self-starter)
  • Inspection, test, and measurement techniques and experience
  • Self-motivated, able to plan, organize and prioritize
  • Maintain the professional competence knowledge and skill necessary for the satisfactory performance of all assigned responsibilities
  • Experience in DMS (Documentum D2), and/or LMS (Plateau) is desirable

Responsibilities For Catalog Quality Associate, Chinese Resume

  • Experience with ISO 9000 and QMS is desired
  • Experience of quality management system design and implementation
  • Uses visual aids that are effective and appropriate for communication medium
  • Liaising with relevant internal stakeholders regarding development & implementing process requirements
  • Recording and preparing meeting minutes
  • Standing while facilitating training occasionally
  • Issuing lot numbers and preparing batch records

Responsibilities For Development Quality Associate Resume

  • Understanding of in-process and dock auditing
  • Understanding of the product’s intended use and manufacturing process
  • Walking through the manufacturing facility
  • Training system administrationo
  • Operating part/full cycle of QA process of SAP HANA
  • Designing CRFs and tools for the management of clinical research
  • Working knowledge of lean principles (i.e., Six Sigma)

Responsibilities For Operational Quality Associate Resume

  • Understanding of records management principles
  • Interacting cross functionally to ensure a “seamless” product launch
  • Building an environment and culture that supports the core values and which enables development of key talent
  • Managing and organization ability
  • Understanding of Quality Assurance/Quality Control methods, principles, and practices

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