Senior Quality Assurance Specialist Resume Sample

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Gabrielle Kerluke
62533 Davis Glens,  Dallas,  TX
+1 (555) 454 5224

Work Experience


Senior Quality Assurance Specialist
11/2016 - PRESENT
Detroit, MI
  • Strong experience in working in a GMP compliant environment; ideally QA or packaging and labelling functional experience
  • Biotech/Pharmaceutical experience is desirable but not essential
  • Experience of working with a team environment
  • Computer literate (Windows Office/able to pick up new systems quickly)
  • Responsible for ensuring compliance with all applicable provisions of the Shire Quality Management System, and the regulations and standards applicable to Round Lake operations
  • Leads in-plant audit readiness efforts for assigned areas and assist other areas within the facility in understanding FDA, local country regulations, and Shire quality requirements. Maintains a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
  • Supports management during internal/external audits and inspections and participates in the coordination and management of audits/inspections as required. Coordinates the development, review, approval, and submission of responses to cited observations or deficiencies. Tracks and reports on commitment status through closure
CT Senior Quality Assurance Specialist
10/2009 - 09/2016
Phoenix, AZ
  • Responsible for the execution and maintenance of the Quality System Integration Project Plan. Evaluates Quality Systems and writes, reviews, analyzes, and revises written Standard Operating Procedures (SOPs) as needed in order to assure compliance to regulations, and corporate procedures and policies
  • Site subject matter expert responsible for managing external inspection and internal audit response and action commitments within the Trackwise 8 Inspection & Customer Management System (ICAMS) and Quality Regulatory Audit Management System (QRAMS) workflows
  • Schedules and coordinates Management Review and Quality Data Review meetings, including summaries of the data presented, conclusions, and meeting minutes as required. Documents and tracks action items and follow-up commitments to closure. Responsible for trending and presentation of Quality System indicators for owned systems
  • Prepares and submits annual Product Quality Reviews and quarterly lot reports. Prepares and reviews site-impacting regulatory submissions working with site subject matter and technical experts to assure timeliness and accuracy. Responsible for maintaining the Site Master File (SMF) and for the review of product/process change controls for SMF impact
  • Leads and manages multiple projects/teams including corporate quality policy and procedure gap analysis and implementation, SOP and training code audits, and other quality system improvement projects
  • Conducting and overseeing Quality Assurance activities
  • Managing the triage and prioritization of testing
  • Communicating successfully up and down the ladder in an Agile, matrix environment
  • Thinking on your feet, exhibiting nimbleness and agility

Education


Southwestern University
2003 - 2008
Bachelor's Degree in Chemistry

Professional Skills


  • Excellent problem solving skills, analytical thinking, and visionary skills
  • Effective presentation/communication skills, project/resource management skills
  • Excellent time management skills with ability to multi-task and prioritize to meet deadlines
  • Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management
  • Excellent written and oral communication skills including an ability to communicate with senior managers in the organization
  • Possesses proven leadership and coordination skills and can manage several resources on a day-to-day basis
  • Strong proof-reading/editing skills; attention to detail

How to write Senior Quality Assurance Specialist Resume

Senior Quality Assurance Specialist role is responsible for interpersonal, training, computer, analytical, word, design, analysis, manufacturing, events, risk.
To write great resume for senior quality assurance specialist job, your resume must include:

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

Contact Information For Senior Quality Assurance Specialist Resume

The section contact information is important in your senior quality assurance specialist 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 Senior Quality Assurance Specialist Resume

The section work experience is an essential part of your senior quality assurance specialist 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 senior quality assurance specialist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular senior quality assurance specialist position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Senior Quality Assurance Specialist resume experience can include:

  • Demonstrate Target Level 2 Leadership Capabilities with consistent strong demonstration of the four target Skills and Competencies listed below
  • Has excellent problem-solving skills
  • Strong computer skills with Word and Excel required
  • Ability and skill to effectively manage multiple tasks and participate in the execution of change management plans
  • Computing skills including applications (MS Office, Visio, Subversion, Jira, SharePoint, TFS, etc)
  • Engage and coach teams to solve problems, continuously developing problem solving skills

Education on a Senior Quality Assurance Specialist Resume

Make sure to make education a priority on your senior quality assurance specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior quality assurance specialist 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 Senior Quality Assurance Specialist Resume

When listing skills on your senior quality assurance specialist 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 senior quality assurance specialist skills:

  • Strong time management skills and the ability to prioritise activities
  • Good PC skills including word processing and spreadsheet software
  • Able to effectively prioritize and manage multiple projects and tasks
  • Demonstrated ability to effectively communicate data to cross-functional teams
  • Strong knowledge of computer and computer software (Excel, PowerPoint, Lotus Notes, SmartSolve, SAP), as well as trending and analytical skills
  • Excellent organizational skills, with ability to multitask and work in a high pressure, as well as dynamic environment

List of Typical Experience For a Senior Quality Assurance Specialist Resume

1

Experience For CT Senior Quality Assurance Specialist Resume

  • Proved ability to work effectively in a team setting as well as independently with minimal error and guidance
  • Demonstrate the ability to make critical decisions regarding quality system compliance, then assess, and articulate risk when evaluating a situation
  • Strong performance history of consistently meeting or exceeding expectations
  • Monitors testing effectiveness and ensures appropriate use of all testing tools
  • Experience providing testing of responsive web applications
2

Experience For Senior Quality Assurance Specialist Resume

  • Experience managing test cases and bugs using JIRA
  • Has experience testing mobile applications
  • Has experience with programming languages such as Cucumber, Ruby, JavaScript, or SQL- PL/SQL
  • Serves in advisory capacity to other personnel within the company in providing assistance in Good Laboratory Practices
  • Reviews lab sample results and manufacturing records relative to qualification/validation activities
  • Develops a thorough and effective Test Strategy, including automation integration for regression beds
  • Quality Assurance experience in a pharmaceutical aware or related environment
  • Basic experience of process design and improvement
3

Experience For CT Senior Quality Assurance Specialist Resume

  • Have experience with Cucumber or other Rest Assured BDD frameworks to integrate open source tools for automated testing
  • Experience with Windows OS, javascript and XML is highly desirable
  • Training and mentoring of junior members of the QA organization and providing QA coaching to other non-QA employees within the area supported
  • Reviewing & Approving and leading CMO deviations, change controls, CAPA, investigations and nonconformance reviews, etc
  • Mentoring and developing team members regarding audit results through insightful feedback
4

Experience For Senior Quality Assurance Specialist Resume

  • Ensuring the product supply and resolving the possibilities of Product Shortage
  • Driving quality excellence within operations with a specific focus on
  • Serving as a resource for relevant compliance and quality management systems
  • Working knowledge of Regulatory Requirements (EMEA/FDA Regulations, GMP, etc.)
  • Working knowledge of Microsoft Excel, statistical analysis
  • Working knowledge of investigation and cause-analysis tools (such as Fishbone, 5 Whys, is/is not, casual diagram)
  • Ensure end-to-end beverage quality for Foodservice by identifying risks and non-compliances, ensuring corrective action, and documenting preventative actions
  • Lead with compiling, analyzing and driving First and Repeated Contact Resolution improvement initiatives
  • Pro-active for Trending of EM and UM data including approval of annual reporting
5

Experience For CT Senior Quality Assurance Specialist Resume

  • Assists with arranging, scheduling, and assisting sponsors’ Quality Assurance inspections and regulatory agency inspections
  • Lead laboratory activities related to beverage quality and food safety – including the evaluation of new products and dispensing equipment
  • Has a deep understanding of professional software engineering best practices for the full software development life cycle
  • Promotes and drives continuous improvement culture with Packaging and Labeling CMOs
  • Support data gathering / reporting for SM OpU Compliance Index
6

Experience For Senior Quality Assurance Specialist Resume

  • Responsible for assuring that R&D work is performed per regulatory requirements including 21CFR 820, ISO 13485, ISO 14971, MOD 93/42/EEC
  • Interact with the Regulatory Affairs team in reviewing and evaluating submissions to regulatory agencies
  • Trains personnel on complaint handling and adverse event reporting as required
  • Results orientated with a bias for action, taking responsibility and owning delivery
  • Chair bi-weekly testing meetings with internal and external partners as well as various testing groups
7

Experience For CT Senior Quality Assurance Specialist Resume

  • Coordinate and oversee the execution of test plans/or test cases during the designated testing timeframes
  • Collaborates with other departments and Development Groups in the planning and management to optimize testing activities
  • Review of production, packaging, and labeling records
  • Assist in maintaining the quality management system and manage tooling required to host QMS
  • Provide Oversight for biologics products Packaging and Labeling CMOs
  • Liaise with the Packaging Tech Ops and assure the compliance of current and revised packaging art-work process
  • Oversight/Approval of CMO updates to Bill of Materials (BOM), Incoming Specifications Documents, Master Packaging Records (MPR)
  • Approve written methods (includes tracking and filing)
  • Scientific knowledge of PCR, biopotency assays, sequencing, blotting techniques and viral clearance and safety studies
8

Experience For Senior Quality Assurance Specialist Resume

  • Teaches production personnel how to train others using the fundamentals of On-The-Job Training
  • Manages training of all new and existing QA employees
  • Serve as subject matter expert regarding all testing activities
  • Verifies compliance to quality procedures at the site during each stage of the operation Oversees product non-conforming and complaint investigations
  • Performs QA review, routes and implements change controls on packaging, labeling, and distribution activities
  • Verifies personnel meet training requirements for their role and that training is documented
  • Performs internal audits and / or visits Pall manufacturing facilities to become familiar with Pall Biopharm
  • Is proficient with automation frameworks and automated testing tools like Selenium
9

Experience For CT Senior Quality Assurance Specialist Resume

  • Apply Quality Review standards and follow directions on properly applying ‘yes/no/na’ questions to determine accuracy
  • Cross-browser and cross-platform testing
  • Defect creation in bug tracking system
  • Plans and oversees planning and execution of SIT, Regression, End to End and automated regression as appropriate
  • Drive test execution and manage testing resources
  • Organizes and secures test resources including IT testers, vendor resources, environment support resources, etc
  • Works to secure test environments for all applications involved in end-to-end testing
  • Escalate testing defect, problems, and issues to Project Manager for timely resolution
10

Experience For Senior Quality Assurance Specialist Resume

  • Provide Roll Up testing metrics to program
  • Facilitate forums for continuous monitoring of QMS metrics
  • Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration
  • Evaluates complaints for adverse event reporting as applicable. Verifies decisions for “Vigilance report not required” determinations
  • Within complaint system, acts as Safety Officer for adverse event reporting purposes
  • Based on assessed risks, coordinates the escalation to Medical Reviewer(s) for decisions regarding the potential for serious injuries

List of Typical Skills For a Senior Quality Assurance Specialist Resume

1

Skills For CT Senior Quality Assurance Specialist Resume

  • Strong computer skills including word processing, spreadsheets, and presentations
  • PC/Computer skills & experience with ERP Shop Floor software
  • Prior experience functioning within a manufacturing or testing facility
  • Advanced skills in coordinating subsystem and/or system testing activities with programs and other organizations
  • Experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience
2

Skills For Senior Quality Assurance Specialist Resume

  • Utilize MS Excel to effectively communicate information (e.g. pivot tables, complaint and CAPA trending, Pareto Charts, etc.)
  • Familiarity with Good Laboratory Practice standards and experience working in a GLP/GMP regulated research environment
  • Demonstrates solid understanding of industry methodology standards
  • Applies decisive thinking skills and strategies to lower barriers, raise support, and align collective actions towards successful outcomes
  • Excellent working experience with IS0 9001 and basic knowledge of GxP regulations, GAMP 5 and 21 CFR Part 11
  • Demonstrated ability to meet deadlines while managing multiple projects and prioritize work
3

Skills For CT Senior Quality Assurance Specialist Resume

  • Successful teamwork experience and demonstrated leadership abilities are desired
  • Strong experience with HP ALM
  • Communicate effectively with CMOs and assess information provided
  • Work both independently and ability to collaborate effectively with subject matter experts in a cross-functional team environment
  • Able to influence and engage effectively with all levels at retail/distribution, vendor and office locations
  • Prioritize and the flexibility to adapt to changing priorities
  • Computer skills: working knowledge of Internet, MS Word, Excel, Outlook, and PowerPoint
4

Skills For Senior Quality Assurance Specialist Resume

  • Experience with SAP, Trackwise or similar systems – STRONG PREFERENCE
  • Batch / product release experience - STRONG PREFERENCE
  • Planning and organizing; good at time management
  • Experience working in Quality Assurance supporting the manufacturing / packaging of drugs, biologics, or devices - required
  • Experience leading testing for Online and Mobile Banking solutions
  • Strong proficiency in system testing including black box, functional, end-to-end, regression, manual and automation testing
  • Strong proficiency in system testing including black box, functional, end-to-end, regression, accessibility, manual and automation testing
5

Skills For CT Senior Quality Assurance Specialist Resume

  • Experience interfacing with regulatory bodies and working on regulatory submission
  • Experience working directly with CMO's to resolve significant compliance deficiencies associated with downstream processing of biological products
  • Experience of leading or managing people to complete tasks/projects
  • Good working knowledge of US cGMPs, EU cGMPs and familiar with other International GMP standards (e.g. including but not limited to EU, ICH, PIC/S, Japan)
  • Experience in engineering, quality assurance, manufacturing, field service, or plant operations
  • Good knowledge about Windows operating system. Knowledge in MAC operating system would be an advantage
  • Develop test cases, prior to the testing timeframe identified in the testing schedule
6

Skills For Senior Quality Assurance Specialist Resume

  • Collaborate with project team resources to understand and prioritize system testing efforts
  • Creates discrepancy reports and performs integration regression testing to verify/validate incorporated fixes to software, components, subsystems and systems
  • Navigate multiple projects with changing priorities and to execute project timelines in a fast-paced environment
  • Related work experience in food manufacturing environment
  • Experience in testing as an analyst or engineer
  • Diploma in Operations Management, Quality Management, or other related education by training or by work experience
  • Retail Lending- Mortgage Loan experience
  • Experience producing overall Test Strategy and Test Plans
7

Skills For CT Senior Quality Assurance Specialist Resume

  • Test automation experience using industry tools such as HP UFT, SoapUI, Eggplant, Selenium, etc
  • Experience working with HP ALM (QC)
  • Experience related to customer complaint handling and corrective/preventive action activities within the medical device industry
  • Experience processing large amounts of technical data (manuals)
  • Possesses a solid understanding of the SDLC and Quality Assurance concepts, metrics analysis, methodologies and documentation standards
  • Strong proficiency in black box, functionality, end-to-end, integration, regression, manual and automated testing
8

Skills For Senior Quality Assurance Specialist Resume

  • Possesses 5 years of banking industry experience
  • Experience in Software Engineering Development
  • Technical experience in test automation and in design and development of automation frameworks covering different technology and application platforms
  • Deep understanding & experience of automation development tool sets (e.g., Selenium, Cucumber, SOAPUI, TestNG, NUnit,UFT)
  • Knowledge of FDA and EMEA regulations, equipment qualification and cleaning, computer and process validation
  • Excellent understanding of quality systems, cGMPs and regulatory agency guidance as applicable to drugs or biologics
  • Experience testing Web-based software applications in a SaaS architecture and on mobile devices
  • Practical experience for at least 7 years in the Pharmaceutical Industry in manufacturing/technical/QA or QC role(s)
9

Skills For CT Senior Quality Assurance Specialist Resume

  • Demonstrate success in working in multifunctional teams
  • Knowledge of FDA and EMEA regulations, process validation, and a working knowledge of statistical analysis and root cause analysis is required
  • Has experience analyzing code coverage of automation tests
  • Strong capabilities and knowledge in software development (requirement specification, code implementation and testing) as well as agile development
  • Experience in aseptic or sterile processing in cleanrooms or microbiological lab analyses with high focus on pharmaceutical environment
  • Provide guidance and coaching for the areas of responsibility as defined in items 5 for less experienced individuals within the plant
  • Experience interpreting quality system requirements
10

Skills For Senior Quality Assurance Specialist Resume

  • Proficiency with Computers (MS Office, especially Microsoft Excel – data analysis); Good working knowledge of Internet
  • Review production change notice for accuracy; confirming all materials listed are valid and accurate
  • Experience with test automation tools and frameworks such as Selenium, Appium
  • Experience of analytical method/technical transfer to contractors
  • Experience & knowledge of vender (DP, DS etc) audit. 3

List of Typical Responsibilities For a Senior Quality Assurance Specialist Resume

1

Responsibilities For CT Senior Quality Assurance Specialist Resume

  • Effectively utilizes applicable computer applications, including Laboratory Information Management System, Microsoft Word, Excel, and Access
  • Experience working in a regulated environment in Quality in the biotech industries
  • Previous GMP, Root Cause Analysis, and technical writing experience
  • Support validation activities related at the CMO’s
  • Experience in Quality
2

Responsibilities For Senior Quality Assurance Specialist Resume

  • QA experience required
  • Performs Quality Assessment on all validation documents
  • Experience with formal test methods and quality assurance programs in an Internet, software or media development environment
  • Experience, or familiarity with Front End development
  • Writes and reviews Product Validation, Qualification and Assessment Documents
  • Writes and reviews Computerized System Validations and Assessment Documents
  • Working knowledge of delinquency and foreclosure servicing, adjustable rate mortgage servicing, escrow accounting, payoff processing, and assumption processing
  • Working knowledge of mortgage banking regulations (HUD, FNMA, FHLMC, GNMA, VA, USDA, 184 and State and Federal laws)
3

Responsibilities For CT Senior Quality Assurance Specialist Resume

  • Leading or QA representative on CMO projects
  • Working knowledge of loss mitigation requirements to include HAMP, HAFA and other programs as dictated by the investors
  • Working knowledge of MSP / Blackknight software
  • Assists with identifying and reporting on quality trends, as well as works on resolving gaps
  • Manual testing using different test types and platforms
  • Create automation scripts using Selenium Web Driver, Appium/ ExperiTest, Jenkins and Maven and perform regression testing
  • Support customer project and programs by assisting in or leading in routine and non-routine administrative tasks such as
  • Conduct planned and random audits of manufacturing processes and products during and after the production processes
4

Responsibilities For Senior Quality Assurance Specialist Resume

  • Prepare written QC reports on mortgage servicing reviews, using a standardized, consistent and objective format
  • Seek out and complete online or offsite investor training as it relates to the job function. Attend industry conferences/training classes as required
  • 75%: QA contact for North Reading and Belmont warehouse operations
  • Work with the development team to understand how changes in the software product affect maintenance of test scripts and the QA automated testing environments
  • Ensure enterprise automated defect management and tracking is used
5

Responsibilities For CT Senior Quality Assurance Specialist Resume

  • Plans and conducts test planning, status and Exit Gateway meetings
  • Coordinates application teams with other interfacing applications to resolve issues
  • Assist other functions ensuring QMS is up to date and relevant to business needs
  • Management of Quality Assurance activities of external packaging partners
  • Senior Lead - Available as a resource to other Quality Assurance Specialists reviewing assign sample loans in their designated specialty of complex loans
  • Review samples of commercial loans for SOX, FHLB pledge, SBA reporting and other multiple functions for accuracy
  • Manage the retrieval of reverification information. Monitors all outstanding re-verifications to ensure responses are received and appropriately recorded
6

Responsibilities For Senior Quality Assurance Specialist Resume

  • Coordinate and assist with writing department's procedures
  • Create automation test framework using open source tools like Selenium
  • Manage customer communication and problem solving, which includes general program inquiries
  • Confirm that USPS mailing guidelines are followed; scan barcodes for readability
  • Proactively drive product and process improvement activities using PPI
7

Responsibilities For CT Senior Quality Assurance Specialist Resume

  • Environmental monitoring excursions
  • Assist in troubleshooting systemic GMP issues
  • Assist SR QA Specialist in process mapping and system analysis
  • Assist in “on the floor” activities (line clearances, product inspection, interim problem solving, etc.)
  • Assist in conducting GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations
8

Responsibilities For Senior Quality Assurance Specialist Resume

  • Reviews, writes, and maintains up-to-date SOPs for QA unit and assists in the updates of standard operating procedures
  • Conducts GLP training programs for technical laboratory personnel
  • Leads or facilitates 8D and 4D Problem solving events for special requirements or high profile failures
  • Responsible to implement the Hanover On-Line Problem Solving Tool at the plant level
  • Conducts on-going updates and maintenance to the system as needed
  • Work with Release Leads with objective of refining release process
  • Continually research and evaluate new testing tools, techniques, and technologies
9

Responsibilities For CT Senior Quality Assurance Specialist Resume

  • Ensure all status reporting is accurate and timely
  • Escalate any testing environment concerns and issues
  • Performs the internal and external audits according with the regulatory and corporate requirements
  • Responsible for cGMP compliance of assigned manufacturing operations / areas
  • Interface with the Customer’s Quality Assurance Representative and other authorities whose mandate is the Assurance of Quality
  • Prepares/manage all 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
  • Maintain in compliance with Shire’s record policies completed Gap Analysis
  • Review and approve change control documents
10

Responsibilities For Senior Quality Assurance Specialist Resume

  • Participate in the elaboration of local SOPs and execute quality activities such as Change Controls, CAPAs, Deviation Investigations, Mock recall, Complaints, etc..
  • Validation / Revalidation activities
  • Experience, or familiarity with, one or more Web development language and/or tool(e.g. JavaScript, HTML,Selenium) is an asset
  • Process improvements / Global Pharm Tech support
  • Analyzes end user requirements and customer reported defects to design and execute manual or automated test strategies across a variety of architectures and cutting-edge technologies

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