Associate, Quality Assurance Resume Sample

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Julie Welch
13367 Dallin Plains,  San Francisco,  CA
+1 (555) 300 4086

Work Experience


Senior Associate, Quality Assurance
09/2016 - PRESENT
San Francisco, CA
  • Manages labelling issues, reviews and approves packaging materials in compliance with product’s license, internal procedures and applicable regulation
  • Ensure site training plan and system for content/documentation are in place and maintained.
  • Performs in-process checks and inspections; review batch records to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released through incoming and in-process inspection process
  • Performs incoming inspections on components and raw materials; and send samples to external testing laboratories (where appropriate). Verify that all limits and specifications have been met
  • Perform complaint investigations through analyzing returns and reviewing batch records. Provided written reports of findings
  • Maintains the Calibration program, distributes monthly calibration reports and sends items to external calibration sources
  • Maintains the CAPA program, manages monthly CAPA meetings and distributes minutes from the meetings
  • Conducts environmental monitoring sampling and testing
  • Participates in compliance audits (internal and external) and correct deficiencies as required through the appropriate system
Associate Quality Assurance Engineer
07/2010 - 08/2016
Phoenix, AZ
  • Demonstrated proficiency with Microsoft Word, Microsoft Excel, and Microsoft Outlook programs
  • Be able to lift up to 35 pounds
  • 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
  • Review and approve Culture Media, Bulk Production, and Process Simulation batch records
  • Review and approve records from supplemental manufacturing operations through system reports and logs
  • Coordinate, maintain, and close Risk Processing memos
  • Assist in investigations, which includes interactions with vendors or Merck's Supplier Development and Procurement Management for issues associated with raw materials and components
Associate, Quality Assurance
05/2007 - 06/2010
Chicago, IL
  • Approve batch notes entered into SAP
  • Present deviations at Event Notification meetings; as well as, perform product inventory control activities associated with the deviation
  • Review and Release incoming components, including performing incoming inspections
  • Author and review SOPs
  • Direct support of validation activities and other associated Quality functions
  • Serve as MRB coordinator
  • Serve as QA resource for cleaning verification/validation
  • Review and approve validation/quality reports
  • Support process development including attending project meetings and review and approval of new master documents in QUMAS

Education


Grand View University
2002 - 2007
Bachelor's Degree in Life Sciences

Professional Skills


  • Good communication skills and excellent interpersonal skills
  • Possess strong analytical skills in assessing user, functional and technical requirements, as well as working understanding of functional testing
  • Strong computer skills including working with spreadsheets, browsers and mobile technologies
  • Demonstrate trouble shooting skills
  • Strong communication skills, including both verbal and written communication
  • Team player with good communication skills to work effectively in a global team
  • Proven leadership skills to independently manage a track of work with 3 - 5 people, during various phases of the project lifecycle

How to write Associate, Quality Assurance Resume

Associate, Quality Assurance role is responsible for technical, analytical, organizational, interpersonal, software, manufacturing, analysis, organization, leadership, troubleshooting.
To write great resume for associate, quality assurance job, your resume must include:

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

Contact Information For Associate, Quality Assurance Resume

The section contact information is important in your associate, quality assurance 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 Resume

The section work experience is an essential part of your associate, quality assurance 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 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 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 resume experience can include:

  • Good organizational skills; developing ability to multi-task and coordinate multiple activities in parallel with a sense of urgency
  • Strong analytical skills and understanding for causality
  • Excellent judgment in the presence of competing priorities and incomplete data; proven ability to make difficult trade-offs
  • Good conflict resolution and negotiation skills helpful
  • Good organization skills needed
  • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices

Education on an Associate, Quality Assurance Resume

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

When listing skills on your associate, quality assurance 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 skills:

  • Solid oral and written communication skills; ability to communicate with management, peers and subordinates effectively
  • Strong project management, problem-solving, and analytical skills; experience with project management tools
  • Good communication (written/ oral) skills
  • High energy, good organizational skills, and stress-resistant
  • Strong written and verbal communication skills, and the ability to describe complex problems in a concise manner is required
  • Good project management skills LI-POT2

List of Typical Experience For an Associate, Quality Assurance Resume

1

Experience For Senior Associate, Quality Assurance Resume

  • Prioritize work and quickly adapt to changing priorities
  • Effectively work in a team environment while being self-directed and highly motivated
  • Knowledge and skills -
  • Experience in a QA role, preferably in an Engineering organization
  • Experience in testing complex web sites and mobile apps across multiple browsers, devices, form factors and responsive websites
  • Experience in accounting and tax required
  • Previous Quality Assurance testing experience
  • Five years of experience in software development, testing, project management, and business analysis
  • Direct experience with document management, SOP development, and training is required
2

Experience For Associate Quality Assurance Engineer Resume

  • Work closely with technology partners to identify, prioritize and automate the testing various functionalities
  • 6 months to 12 months coding experience in JAVA
  • Hands on testing experience on web and mobile applications
  • Experience with http debugging tools such as Charles Proxy
  • Experience with in-browser web debugging tools
  • Development experience with Automated Testing Frameworks such as Selenium/Java
  • Experience in Quality Assurance including ALM/Quality Center
  • Participates in or leads projects and improvements with global impact. Mentors and trains less experienced Associates across Quality Assurance functions
  • Handling the Quality oversight over the manufacturing operations (“on the floor”) (includes warehouse operations)
3

Experience For Senior Associate Quality Assurance Resume

  • Working on investigations following deviations and related CAPAs
  • Handling and supporting Global Change Controls
  • Working knowledge of SQL, SQLServer, & TOAD
  • Supporting the Batch release process
  • Understanding of the requirements for quality documents in a FDA regulated industry is required
  • Troubleshooting, Defect Identification and Resolution
  • Working knowledge of Windows, Mac OSX, Android, iOS
4

Experience For Associate Quality Assurance Analyst Resume

  • Tracking and facilitation of the closure of External Supplier commitments
  • Perform routine monitoring of manufacturing, packaging, QC, and maintenance/engineering areas to ensure compliance with all approved SOPs
  • Leads operating entities in preparing for, hosting and closing out internal and external inspections/audits as necessary
  • Facilitate and participate in scrum meetings for one or more product teams including backlog grooming, sprint planning, sprint review and retrospective
  • Oversight the Aseptic Processing filling and provide advice and guidance during the process
  • Plan and integrate automated test scripts with continuous integration tools and setting up automation testing environment
  • Assists in training/mentoring of team members
  • Production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
  • Web Application Testing- Protractor (Angular JS based framework Testing)
5

Experience For Associate Quality Assurance Specialist Resume

  • Mobile Application Testing- SeeTest (i-OS based application Testing)
  • An understanding of software development in a team, and a track record of shipping software on time
  • Execute raw material receipt, inspection, and sampling including completion of GMP documentation to support raw material disposition
  • Monitor trends and highlight risk factors for product quality complaints including response times, outcomes, and actions arising from complaints
  • Contributes to the Annual Product Review process, including scheduling, collection of data, and report preparation
  • Work as a contributing member of a Quality Assurance team and assist with testing of RA software
  • Report defects clearly using our bug tracking tools such as JIRA
  • Review documents generated by contract manufacturers including executed batch records, testing results, CofA, analytical methods, etc
  • Thoroughly tests software to ensure proper operation and freedom from defects and/or supports testing as a witness to testing requirements
6

Experience For Associate Quality Assurance Resume

  • Assists in identifying and initiating QA CAPA activities (deviations, lab investigations, OOS)
  • Executes functional testing based on analysis and understanding of the requirements and deployment environment
  • Travel and administer onsite support at music festivals, provide hands on training, troubleshoot equipment, and assist with general support as needed
  • Review batch documentation for clinical products and perform product release per standard operating procedures
  • Prepare and conduct acceptance testing of new or modified applications/systems
  • Responsible for changes that could potentially impact product quality are assessed according to procedures
  • Web Services/API Testing- SOAPUI
  • Work with operations partners, planning, and supplier quality management to resolve issues real-time
  • Support internal and external audits of incoming QA raw material processes and facilities
7

Experience For Operations Associate, Quality Assurance Resume

  • Perform and/or ensure proper investigation and documentation of drug product complaints associated manufacturing investigations
  • Support the GMP training program
  • Knowledge of working in quality systems within the pharmaceutical / biopharmaceutical industries
  • Identify opportunities to adopt innovative testing technologies and techniques, look beyond the obvious for continuous improvement opportunities
  • Know and follow the Software Development Methodology and perform required testing and deliverables throughout the SDLC
8

Experience For Marketing Associate, Quality Assurance Resume

  • General understanding of Quality concepts; able to practice and implement them
  • Define and perform iteration and regression testing
  • Provide support to the startup activities required to set up cGMP manufacturing operations at the Norwood, MA facility
  • Write and execute test plans for our digital properties, including web and mobile applications
  • Create and maintain test data using our internal CMS tools
  • Clearly communicate technical issues verbally and in writing
  • Utilizes QA checklists to evaluate content of reports and compliance with reporting criteria
9

Experience For Associate Quality Assurance Manager Resume

  • Scans, photo copies, files and ensures that records are kept up-to-date. Participates in inter-departmental meetings and contributes to policy-making decisions
  • Provides support to the QA department with incoming material inspection as per GMP requirements. Reviews batch records and other GMP documentation
  • Understand and interpret of applicable GMP Regulations pertaining to the Quality systems or processes
  • Support the process of periodic monitoring of external suppliers
  • Support tracking of complaint investigations related to contract manufactured products and devices
  • Generate LIMS batches and enter results obtained from contract manufacturing site into LIMS
  • Execute metric collection and review for contract manufacturing site teams
  • Work within an electronic reporting tool (such as Trackwise) to help manage client audit and regulatory inspection reports and CAPAs
10

Experience For Associate, Quality Assurance & Documentation Resume

  • Provides QA related training where required
  • Provides support to the QA department as needed depending on the nature of the associated work or project
  • Assist with training new contingent employees, as needed
  • Assist with any training documentation and records either hard-copy or in eLMS, if needed
  • Problem solving and risk management mindset with an aptitude to overcome obstacles
  • Attention to detail while still being proficient
  • Perform and maintain safe working practices and safety initiatives within their functional area
  • Performs audits (critical phase and manufacturing) and appropriately documents the findings
  • Perform functional testing of applications using manual test cases to confirm user interface, usability, data validation, integration and client end-to-end functionality. This includes regression testing and crossbrowser validation as needed

List of Typical Skills For an Associate, Quality Assurance Resume

1

Skills For Senior Associate, Quality Assurance Resume

  • Strong word processing, spreadsheet, presentation and project management application skills
  • Quality assurance testing or systems analysis experience (including test case development); or equivalent training and experience
  • Proficient troubleshooting and problem-solving skills
  • Prior experience in working with ACI products – UPF, UP Base 24-eps, ReD Shield, Online Banking etc
  • Good experience with different Operating Systems
  • Effectively communicate with various customers concerning technical issues
  • Technical skills used: XML, XSD, Groovy scripting, Maven, Source Control (git and SubVersion), VirtualBox, Linux/Unix BASH shell
  • Proficient technical writing/review skills
  • Solid GMP knowledge and QA and/or manufacturing experience from the pharmaceutical industry
2

Skills For Associate Quality Assurance Engineer Resume

  • Pharmaceutical industry experience in quality assurance and solid understanding of the pharmaceutical and biotechnology industries
  • Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice
  • EU Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP)
  • Technical Skills: Java, Web (HTML, XML, CSS, PHP, Javascript), Software Developer in Test, Scripting (Shell, Bash, Perl)
  • Analytical and problem-solving skills; six-sigma and defect cause analysis
  • Investigative decision-making skills
  • Ensures compliance to Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP)
  • Proficient Oral & Written communication skills
  • Additional skills required to be successful in this role
3

Skills For Senior Associate Quality Assurance Resume

  • Five or more years of experience in computerized system validation within a regulated environment
  • Previous experience in QA, Validation, or compliance areas
  • Solid experience with manual test case design and evaluation for automation feasibility
  • Strong experience of process design and improvement
  • Building automation and scripts using selenium and good understanding of automation testing strategies and tools
  • Establishing effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person
  • Outstanding working experience with GxP regulations
4

Skills For Associate Quality Assurance Analyst Resume

  • Experience with Java programming, or scripting languages, such as Ruby, Perl, Python, JavaScript, Windows and Unix shell scripting, SQL – T-SQL
  • Experience with developing and executing automated test scripts using Selenium, Visual Studio, or SOAP UI
  • Experience with developing and executing Stress/performance (load) testing
  • Strong working knowledge of various test types including client/server, white-box, black-box, exploratory, and database testing
  • Experience working in biological drug substance manufacturing, aseptic operations, vial filling and inspection operations
  • Review and Verify executable records prior to being provided to manufacturing for the documentation of GMP activities
  • 2+ of current, professional experience analyzing and supporting applications
  • Experience coordinating end user testing
  • Demonstrated understanding of aseptic processing and application of CGMP’s, relevant laws, guidance’s, directives and current industry practices
5

Skills For Associate Quality Assurance Specialist Resume

  • Work experience or educational background that allows for understanding of the complexity of manufacturing biologics
  • Knowledge of Canadian federal legislation and guidelines relating to Good Manufacturing Practices (GMP) and regulatory compliance issues
  • Experience managing projects through to completion meeting timelines
  • Experience evaluating documentation and operations according to company procedures
  • Ensure compliance with Canadian Food and Drugs Act and Regulations pertaining to Good Manufacturing Practices
6

Skills For Associate Quality Assurance Resume

  • Demonstrates an understanding of functional and technical specifications and incorporating this information into test cases
  • Prompt completion of DCRs which includes the editing and processing of documents from Draft stage to the Effective stage
  • Relevant work experience in testing/QA role
  • BSA, AML, OFAC, KYC, Analytics, Testing or similar industry experience required
  • Some experience in JAVA Scripting or/and JRuby or/and Phython
  • Experience with various defect tracking tools
  • Experience in identifying opportunities to resolve business challenges with technical solutions
  • Three years’ experience in a GMP environment such as blood banking, pharmaceutical, medical devices or a hospital
  • Two years’ experience in QA, QC or Quality Auditing
7

Skills For Operations Associate, Quality Assurance Resume

  • Three to five years of experience working as a quality unit member to qualify infrastructure components in a regulated environment
  • Good at making decisions (risk based approach)
  • Strong working knowledge of GMPs for the pharmaceutical and biopharmaceutical industry
  • Direct experience with raw material receipt, inspection, and sampling
  • Solve complex problems and make scientific risk based decisions; experience applying continuous improvement principles in a regulated environment
  • Previous experience assuming technical responsibility (Technical Responsible or Co-Tech. Resp)
  • Quality experience, supporting one or multiple departments
  • Experience with scripting languages like Groovy, Perl, Shell, etc
8

Skills For Marketing Associate, Quality Assurance Resume

  • Experience testing PHP and/or Java code
  • Knowledge of Good Manufacturing Practice (GMP) is an advantage
  • Experience working as both a team player and independently
  • Five or more year’s experience serving the biotechnology/pharmaceutical or medical device industry
  • Experience leading process/ quality improvement projects
9

Skills For Associate Quality Assurance Manager Resume

  • Knowledge of manufacturing processes and relevant statistical techniques (Process Validation, Statistical Process Control (SPC))
  • Solid working knowledge of the FDA Quality Systems Regulations and international quality system standards (e.g. ISO, QSR, ASTM)
  • Quality and manufacturing experience in biotech or pharmaceutical industry
  • Tware development experience using Agile and DevOps model and associated tools
  • Demonstrated proficiency using Excel, Word and Power Point
  • Quality / Industry-related experience in the following disciplines
  • Experience of working with an electronic Quality Management System tool, such as Trackwise or a similar tool
10

Skills For Associate, Quality Assurance & Documentation Resume

  • Quality-related experience in the following disciplines
  • Experience in software testing or related field. (can be secondary education)
  • Promote a risk-aware culture, ensure efficient and effective risk and compliance management. practices by adhering to required standards and processes
  • Experience in a manufacturing environment
  • Three years of experience in software development, testing, project management, and business analysis
  • Three of experience in software development, testing, project management, and business analysis

List of Typical Responsibilities For an Associate, Quality Assurance Resume

1

Responsibilities For Senior Associate, Quality Assurance Resume

  • Thorough understanding and application of Database Management skills to provide efficient data analysis
  • Analytical, interpersonal, and verbal/written communication skills to work with all levels of the organization
  • Experience with QA Support for Finished Goods
  • Demonstrated experience with Quality Systems, such as NC, CAPA, complaints and/or Change Control processes
  • Proven experience managing both offsite and offshore resources required
  • Strong knowledge in validation and method transfer process and applicable regulations
  • Proven work experience as a Software Engineer or Software Developer
2

Responsibilities For Associate Quality Assurance Engineer Resume

  • GMP review of validation documentation and strong knowledge of equipment/facilities/utility /automation systems
  • Technical Skills: Software Developer in Test
  • Continually update knowledge and skill base relating to both new and existing products to increase proficiency in troubleshooting and support capability
  • Experience working in biological drug substance manufacturing, aseptic operations and vial filling operations
  • Experience test planning, execution using CA ARD tool
  • Experience owning and/or leading QA/QC activities like investigations, change controls, and CAPAs processes
  • Experience representing Amgen while interacting with representatives of regulatory agencies
  • Experience in testing web-based solutions
  • Demonstrated understanding and application of CGMP’s, relevant laws, guidance’s, directives and current industry practices
3

Responsibilities For Senior Associate Quality Assurance Resume

  • 2 4 months or longer gap on your resume due to caregiver or staying home with your children. 5+ Years of professional work experience in similar role
  • Related experience and/or training with a least 2 years in a CSV/Quality role. Background in Lifesciences and/or Pharma/Biotech Industries
  • Experience supporting implementation of computerized systems within a GxP environment either as a CSV and/or Quality lead
  • Prioritize QA requests and manage your work queue taking into consideration our quarterly goals
  • Relevant work experience in addition to the following
  • Manual testing experience
4

Responsibilities For Associate Quality Assurance Analyst Resume

  • Cooperates with co-workers, team player. Willingness to contribute to team activities
  • Good attention to detail important
  • Experience in Quality Assurance
  • 6+ months experience in Test Automation with Selenium
  • Prepare scope documents, test plan and Validation plans
  • Experience in test management tool - Quality Center
5

Responsibilities For Associate Quality Assurance Specialist Resume

  • Experience with test management tools such as Quality Center
  • Software quality assurance experience
  • Communicate with authors, reviewers and approvers to drive documents through their lifecycle in a timely and effective manner
  • Experience in quality assurance & quality management
  • A bility to negotiate, communicate and deliver effective Automated Test solutions to both Development and QA organizations
  • Related industry experience in a Quality function
6

Responsibilities For Associate Quality Assurance Resume

  • 3 – 5 years of relevant IT experience
  • About 2 years’ experience in the pharmaceutical industry
  • Experience, preferably in medical device and/or pharmaceutical industries
  • 1 - 2.5 years of relevant IT experience
  • Directly related experience
  • Work experience from pharmaceutical industry, in QA preferable
  • Direct experience with Enterprise resource management software (SAP), MES, Trackwise, and EDM Quality platforms
7

Responsibilities For Operations Associate, Quality Assurance Resume

  • Experience in similar companies as Biogen Brasil (importation and distribution with Multinational company)
  • Experience with internet technologies, live event support, agile and scrum methodologies
  • Experience in payment domain
  • Experience with infrastructure automation technologies like Docker, Vagrant, etc
  • Experience with build automation technologies like Maven, Jenkins, etc
  • Experience from biotech or pharmaceutical industry is an advantage
  • Strong team-player who also have the ability to work independently
  • Experience in business communications (both written and verbal)
8

Responsibilities For Marketing Associate, Quality Assurance Resume

  • Experience with word processing, database and spreadsheet applications
  • Experience with quality systems management in pharma/biotech or highly regulated environment
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Identifying and communicating risk and risk mitigation strategies
  • Understanding of testing principles and phases
  • Understanding of various protocols, languages, platforms, etc., including: HTTP/S, SSL, XML, XSD, JSON, SVN
9

Responsibilities For Associate Quality Assurance Manager Resume

  • Evaluating documentation and operations according to company procedures
  • Beginning to Intermediate knowledge of creating SQL queries through SQL Server 2008
  • Assisting in the design and evolution of the company’s QA process
  • Understanding of Agile and Iterative development methodologies
  • Understanding of both Quality Systems and industry requirements/expectations of a NC, CAPA, Complaints and Change Control
10

Responsibilities For Associate, Quality Assurance & Documentation Resume

  • Understanding of key compliance components as it relates to computer systems
  • Understanding of risk-based methodologies as it relates to CSV and general Quality practices
  • Understanding of cross-functional impact of changes in relationship to software updates, bug fixes, new releases of software internally or externally developed
  • Understanding of web page technologies (Web Services, XML, Ajax, HTML, CSS)
  • Understanding of ITSM modules such as Incident Management, Change Management, CMDB, CMS, Knowledge Management or other ITSM applications
  • Understanding of integration methods and tools such as REST/SOAP and JSON

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