Specialist QA Resume Sample
Lauriane Wiegand
4583 Clint Meadows,
New York,
NY
+1 (555) 686 4902
Work Experience
Specialist QA
06/2015
-
PRESENT
Los Angeles, CA
- Career Gap Analysis
- Leads a project team of other software quality assurance engineers and internal and outsourced development partners to develop reliable and cost-effective testing and quality assurance solutions for assigned applications portion or subsystem
- Identify and document test cases for multi-component systems from requirements
- Coordinate and communicate with developers on bug fixes and required modifications
- Execute test cases and document software defects
- Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI’s excellent reputation in the community
- Good written and communication skills, strong investigative skills required as the position involves investigation involving various products and various departments
Senior.specialist QA
03/2010
-
01/2015
Detroit, MI
- Has sound decision making skills along with ability to take quick actions and excellent attention to detail
- Demonstrated understanding of GMP's, root cause analysis, compliance requirements, and regulatory requirements to assess product, procedures, and recommended improvements to make quality decisions
- Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product
- Develop and execute Quality Assurance test plans and test cases to thoroughly test the business applications based on the clients’ requirements and the development release documents
- Work closely with all other technical teams to ensure effective cross-team coordination during the testing process
- Identify, log, report and track defects found in the release. Prepare clear and concise written reports on defects found during QA process
- Asset Management experience would be beneficial however is not required
- Knowledgeable and experience working with Quality Assurance methodologies in particular Agile SCRUM is beneficial
Specialist, QA
08/2006
-
01/2010
Dallas, TX
- Self-motivated, strong initiative, flexible and excellent time management skills
- Enthusiastic, team-building attitude and able to work with little guidance
- Serves as ‘Quality on the floor’ to assist and support manufacturing staff in detecting and solving compliance errors in real time
- Manage the quality of raw material suppliers to ensure Amgen’s requirements are met, changes and issues are addressed, and a cycle of continuous improvement is driven between Amgen and the suppliers
- Internal Audit Program
- Assists with planning, scheduling, and maintaining the internal audit program at the site, with the approval of this individual’s management
- Create and route product specification documents, following MAA/BLA/CTA/IND/IMPD filings provided by Regulatory Affairs, in BioMarin’s controlled document system
Education
Arkansas Tech University
2002 - 2006
Bachelor's Degree in Computer Science
Professional Skills
- Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent
- Excellent presentation skills, including written and verbal communication skills
- Highly effective verbal and written communication skills, strong interpersonal skills
- Critical analytical skills, strong verbal and communication skills
- Critical analytical skills, strong verbal and communication skills
- 2 – 5 years of experience in strong understanding of GMPs is required, manufacturing and/or packaging experience required
- Excellent English grammar and writing skills are required for success in writing SOP’s, reports, memos, proposals, etc. required
How to write Specialist QA Resume
Specialist QA role is responsible for interpersonal, training, english, analytical, manufacturing, retail, integration, database, auditing, security.
To write great resume for specialist qa job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Specialist QA Resume
The section contact information is important in your specialist qa resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Specialist QA Resume
The section work experience is an essential part of your specialist qa 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 specialist qa responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular specialist qa position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Specialist QA resume experience can include:
- Excellent communication skills: oral/written and listening
- Excellent problem-solving, verbal and written communication skills
- A team player with excellent verbal, written and interpersonal communication skills
- Proven interpersonal, collaborative and organizational skills
- Excellent implementation and customer service skills
- Excellent organizational skills and ability to multi-task essential
Education on a Specialist QA Resume
Make sure to make education a priority on your specialist qa resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your specialist qa 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 Specialist QA Resume
When listing skills on your specialist qa 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 specialist qa skills:
- Good coaching and on the job training skills required
- Excellent verbal communication and listening skills are required for success required
- Strong mature leadership and interpersonal influencing skills
- Possess strong communication & decision-making skills
- Can effectively back-up supervisor to address technical or business issues with little prior instructions
- Demonstrated prior experience in a QA project leadership role
List of Typical Experience For a Specialist QA Resume
1
Experience For Specialist, QA Resume
- Sound knowledge of Quality Assurance principles, Good Manufacturing Practices and Good Distribution Practices
- Review protocols and reports for validation activities. Perform periodic reviews and remediation activities on validated systems
- Perform compliance reviews of Validation Protocols and Final Reports in support of validation efforts
- Solid knowledge of qualification/validation principles and their practical applications
- Investigational and problem solving skills
2
Experience For Specialist, QA Operations Resume
- Acquired practical experience in Good Manufacturing Practice (GMP) over at least 2 years
- Prior experience with US and EU pharmaceutical regulations, ISO standards
- Provide QA oversight and/or review during the validation process for both Manufacturing/Process functions and QC Analytical lab equipment and methods
- Thorough knowledge of cGMP in the pharmaceutical industry. Good understanding of drug development process
- Experience in a Quality Assurance role supporting GMP operations
- Experienced with installing software builds
- Experience within QA functions in pharmaceutical industry
- Support the Validation Team in evaluating all tests needed to qualify critical equipment, utilities, and processes
3
Experience For Specialist QA Engineer Resume
- Practical knowledge of QC lab equipment, methods and method validation
- Provide Quality support to QC department in method transfer or validation activities and LIR review and approval
- Approve process validation protocols and reports for manufacturing processes
- Experience in a pharmaceutical company or other related industry
- Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person)
4
Experience For Senior Specialist, QA Resume
- Manufacturing Batch Record Review of Biologics (DS, sterile DP, and secondary packaged clinical supplies)
- Managing diverse relationships
- Interpreting GMP regulations
- Act as the Training System ‘expert’ for all day-to-day issues concerning Training and Development
- Develops training plans and trains others, including training outside of area of responsibility
5
Experience For Specialist / Senior Specialist, QA Release Resume
- Prepares reports by collecting, analyzing and summarizing data; makes recommendations
- Assists in developing, customizing, and/or monitoring a department/unit QA action plan to meet each account’s needs
- Exercise judgment within defined Quality Assurance and Manufacturing procedures to determine appropriate action for resolution of manufacturing issues
- Provide quality oversight of the manufacturing, testing, and release of Amgen products at CMOs
- Develops sampling plans by applying attributes
- Assess incoming product lots for compliance to cold chain temperature requirements
- Internal Quality Assurance support for creation and revision of GMP procedures and record generation, including document review, approval, and archival
6
Experience For Senior Specialist, QA Center of Excellence Resume
- Oversee and maintain site inspection readiness program and for Hosting of inspections(self-inspection and regulatory/corporate inspections)
- When necessary, facilitate communication regarding deviations, change controls, complaints and batch disposition between the CMO and Amgen staff members
- Representation at Amgen product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required
- Decision to approve the initial CMO/ testing Lab status
- Comfortable working with regulatory agencies
- Confident in making decisions for minor issues
- Review and approve manufacturing investigations
- Ensure control of systems, processes and product through supporting review and approval of change notices and change control
7
Experience For Training Specialist, QA Compliance Resume
- Assess global standards/policies and emerging regulations
- Responsible for issuing site metrics for compliance and adherence to global requirements
- Deputize for the Snr. Manager, Quality operations during holidays and occasion of absence as required
- Provide status reports, including relevant metrics, to department management
- 2 Responsible for participating in investigation meetings with responsible department and any required support group(s)
- Consistent reporting and communication
- Have a testing mind-set with a passion for quality
8
Experience For Health System Specialist QA Pi Resume
- Used Selenium or equivalent UI testing tools
- Proficient with database use, including data input, archival, and query retrieval
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
- Minimal travel, for training
- Author, edit and review Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and reports independently
9
Experience For International Support Specialist QA Resume
- Lead technical calls for own and overall projects as well as discussions regarding investigations or other issues
- Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies
- Knowledge and application of GMP principles, and working in an FDA regulated environment
- Work independently in conducting quality system and process audits
- Proficient in SAP and Technical Writing
- Knowledge of mobile automation testing tools like Appium and Protractor
10
Experience For Specialist QA R&T Compliance Resume
- ISTQB (or) MTA in Software Testing Fundamentals certification
- Responsible for the supervision and management of personnel within the QAPI program including Infection control, Safety, and the Hospital Liaison
- Preparation for, hosting and management of customer and regulatory inspections
- Develop, execute, and maintain functional test scripts using automation tools and analyze the results of automated tests
- Develop, execute, and maintain regression tests, utilizing both automated and manual test cases
- Identify potential areas for automation of test cases; and edit existing automated tests in accordance with test automation best practices
List of Typical Skills For a Specialist QA Resume
1
Skills For Specialist, QA Resume
- Excellent interpersonal, verbal, and written communication skills with the ability to communicate across all levels of an organization
- Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and adhering to good documentation practices
- Interpersonal skills: team building, consensus building, conflict resolution
- Experience working with Databases, writing SQL queries for data validation
- Interpersonal skills: team building, consensus building, conflict resolution
- Good knowledge of current Good Manufacturing Practices and Sterility Technology
- Min. 5 years experience in Quality, Technical Operations, related Business Operations or GMP regulated environment, experience in sterile manufacturing
- Min. 5 years’ experience in Quality, Technical Operations, related Business Operations or GMP regulated environment, experience in sterile manufacturing
2
Skills For Specialist, QA Operations Resume
- Management skills for management of a team of experts,
- Experience with front-end (UI) and back-end testing (data validation)
- Working experience of test management tool ALM
- Experience developing, and maintaining relevant test metric reporting
- Experience driving decision making by using DAI principles
3
Skills For Specialist QA Engineer Resume
- Experience of training in a GMP, high paced, manufacturing environment
- Experienced with automatically generating data for testing
- Experienced in creating and executing automated test cases (based on Selenium) for web applications
- Experience in aseptic processing including cell culture and protein purification
- Experience working in Agile environment that employs continuous integration processes and automated testing
- Relevant experience in dealing with Quality systems such as Non Conformances, CAPA’s and Change Control,
- Relevant experience in dealing with Quality systems such as Non Conformances, CAPA’s, Change Control, Complaints, Internal and External audits
4
Skills For Senior Specialist, QA Resume
- Relevant experience related to interaction with regulatory bodies, including but not limited to for example IGZ, EMA, FDA, etc.
- Experience with accessibility testing like JAWS, voice-over
- Experience with mobile-first / devices testing
- Experience working with test driven development (TDD/ATDD)
- Demonstrate ability to work in a fast paced agile scrum environment. Work closely with team lead for project planning and execution
- Experience with performance testing tools like WebLoad and Test Runner
5
Skills For Specialist / Senior Specialist, QA Release Resume
- Experience with testing tools
- Experience writing SQL statements
- Experience testing in an Agile software development environment
- Experience interacting with stakeholders
- Experience testing web services, APIs and third-party applications
- Demonstrated ability to coordinate and drive improvement in processes supporting Quality Systems or Quality operations
- Demonstrated success records in auditing and improvement processes
- Strong knowledge of cGMP and guidelines (FDA/EU/WHO)
6
Skills For Senior Specialist, QA Center of Excellence Resume
- Experience of manual/automation test management
- Professional experience in pharmaceutical environment
- Previous experience with quality system transactions (SAP, SM-LIMS, Trackwise, Documentum)
- Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry
- Product related knowledge and experience
- Proven ability to identify, influence and drive process improvement
- Operate efficiently in a complex matrix organization and international environment
7
Skills For Training Specialist, QA Compliance Resume
- Relevant work experience required
- Operate computers/office machines/lab equipment
- Experience with Selenium web browser automation
- Demonstrated ability to learn a new domain rapidly
- Biotech or pharmaceutical industry experience
- Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
- Experience with the “variation management” process
8
Skills For Health System Specialist QA Pi Resume
- Experience as QA engineer
- Strong knowledge of QA practices and policies
- Experience in cGMP manufacturing facility required
- Experience owning deviations, CAPAs, and Change Controls is required
- Selenium/C# test automation experience
- Perform compliance reviews of all applicable Deviations, Investigations, and CAPAs related to qualification and validation
- Review project, validation and change control documentation for the site's QMS (Document Management/Compliance Modules) to assure compliance
- Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with parenteral drug manufacture and medical device production
- Leading / managing cross-functional teams
9
Skills For International Support Specialist QA Resume
- Understanding of aseptic manufacturing processes
- Responsible for scheduling and execution of the site internal auditing program assuring CAPAs are completed in a timely manner
- Problem solving – making complex decisions
- Further technical training in the areas of problem solving, risk assessment would be an advantage
- Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio
- Personal Competencies: Self-awareness, integrity, judgment, vision, adaptability, decision making, and coaching
10
Skills For Specialist QA R&T Compliance Resume
- Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio
- Knowledge of facilities, equipment, and critical utilities supporting the qualification of a pharmaceutical manufacturing facility
- Conduct evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion
- Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process
- Complete daily/ongoing QA auditing of product (slot checks, inter branch, retail and distribution checks)
- Solve a variety issues, following cGMP regulations and company standards
- Develop and explain the test approach in a test strategy meeting to the Business and Project team and get signoff
- Proactively engaging with all areas of the business to ensure full end to end satisfaction of requirements is met
- Support Manufacturing on related process Automation activities
List of Typical Responsibilities For a Specialist QA Resume
1
Responsibilities For Specialist, QA Resume
- Develops a schedule for project completion that effectively allocates the resources to the activities
- Experience: 5-8 years of experience in Quality or Project Management related field
- Strong partnership/relationship with CMO
- Perform batch documentation review, management of changes, complaints, deviations, validations and product annual reviews related to College Park operations
- Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
- Advocate for quality coding and testing
- Perform gap analysis of MPU (manufacturing performance unit) processes with c’GMP and GSK Vaccines Belgium Quality management System
- Contribute to the development of reporting systems for all levels of the customer journey
- Lead and conduct Continuous Improvement processes through analysis of issues coming from the field
2
Responsibilities For Specialist, QA Operations Resume
- Monitor, evaluate and execute required changes to ensure organization’s success in managing Nonconformances and CAPAs
- Subject matter expert in one or more products; owning related test artifacts (e.g. test plans and test cases)
- Detailed requirements analysis, clarifying uncertainties with business stakeholders
- Pro-active investigation/verification of production defects and continuous improvement of regression tests; able to recognize underlying problems and patterns
- Work with internal stakeholders to coordinate user acceptance testing
3
Responsibilities For Specialist QA Engineer Resume
- Provides support to Quality group ensuring consistent application of quality techniques
- Establishes statistical confidence by identifying sample size and acceptable error
- Aids in maintaining Quality systems and other communication tools for Quality group
- Confident in making decisions for non-routine issues
- Defect resolution, including use of statistical methods, and control of material throughout the plant site
4
Responsibilities For Senior Specialist, QA Resume
- Maintains an awareness of QA updates and industry conditions including internal and external to the accounts and districts
- Responsible for preparation and implementation of specific development and training specific plans for QA success
- Active member of the QA Finished Product team ensuring on-time disposition of Alexion finished product
- Supports the business through coordination of day to day operations and change management relating to Quality e-Systems such as TrackWise
- Generation, development and communication of Site Quality Metrics and measurements to support the on-going development of site compliance
- Advanced understanding of pharmaceutical laboratory and / or production operations
- Ensure QA compliance in its QC department (Biochemistry and Physicochemistry),
- Representation in meetings : intra and inter department
5
Responsibilities For Specialist / Senior Specialist, QA Release Resume
- QA spokesperson for the quality system department
- QA representative of quality improvement projects
- Prepare and lead weekly deviation meetings
- Review and challenge the QC deviations and CAPA of its QC department
- Ensure the implementation of CAPA
- Manage and follow-up of the major and transversal CAPA
- Review at least on monthly basis the quality system status of its QC department (UE, CP, changes …)
- Report any major event to its QA manager
- Ensures deviations, complaints, change controls, OOS investigation, maintenance and calibration plans are reviewed and handled in a timely manner
6
Responsibilities For Senior Specialist, QA Center of Excellence Resume
- Acts as QMS subject matter expert (= knowledgeable of the QMS standard related to the area of expertise, ensure all requirements of the standards are cascaded in SOP’s, accountable for gap analysis and related action plans)
- Ensure customer’s satisfaction in complaints and minimize legal claims
- BS/MS in a related scientific discipline
- Knowledge and application experience with batch record review, product disposition/release, change control, SOP review, contractor management, qualification and validation review, technology transfer, management notification processes
- Professional integrity and maturity are required
- 3) Compliance Systems: Implements and maintains the activities for development batch record review, SOP review, contractor management, qualification/validation review, and technology transfer, in compliance with cGMPs, SOPs, good documentation practices and in accordance with corporate, regulatory and project timeline expectations
7
Responsibilities For Training Specialist, QA Compliance Resume
- 4) Vendor Contacts: Communicates as required, with outsourced manufacturing, packaging/labeling and/or testing service providers regarding quality assurance issues noted during reviews
- 5) Communications: Proactively communicates, works with and provides timely services to staff and internal colleagues in QA, QC, AR&D, Investigational Materials Supply Chain (IMSC), Information Systems, Metrology, Facilities and Training groups
- Conduct regulatory surveillance to maintain current regulatory expectations and devise and provide GXP training to the facility, as applicable
- Perform Quality on the floor responsibilities during production
- Review Standard Operating Procedures in document management system
- Review and oversees execution FAT, SAT, and Commissioning of Equipment
- Lead or participate in inspection readiness plans and activities and serve as subject matter expert in quality assurance systems
- Product and Material Release
8
Responsibilities For Health System Specialist QA Pi Resume
- Independently review and perform disposition of raw materials, components and cell banks
- Oversee reference standard and retention program
- Provide QA representation on projects with clients
- Support Lot Release Activities
- SAP Quality Management of Quality data
- Develop and revise applicable SOPs and provides compliance oversight and support to other departments upon request
- Perform compliance reviews of change control requests and serves on Change Control Board
- Review and suggests continuous improvements to current validation practices, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies
9
Responsibilities For International Support Specialist QA Resume
- Experience in the start-up and validation of a cGMP facility for FDA approval
- Proficient in the use of Microsoft Office and the ability to learn other programs
- Provides support and compliance oversight to MFG, QC, and Attribute Science staff in the execution of their processes, procedures, and use of quality systems
- Internal Quality Assurance support for GMP warehouse and inventory management operations
- External Quality Assurance support for Logistics Service Provider problem reports, temperature excursions, facility changes, audit reports, etc
- Internal Quality Assurance support for Distribution functions in establishment and maintenance of specific product transportation lanes and modalities, including shipper qualification and management
- Support investigations/deviation reports (Clinical Temperature Excursion Tracking System and Nonconformance)
- Manage QA product reserve sample inventory
- Perform all activities in compliance with Amgen safety standards and SOPs
10
Responsibilities For Specialist QA R&T Compliance Resume
- Write, review and approve SOPs in accordance with Amgen Policies
- Participate in site activities associated with QMS programs(e.g., Validation, Complaints, Change Control)and provide active input into shaping the future direction of these systems
- Establish and track key metrics
- Assures final drug products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements
- Provide oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements
- Accountable for the system performance/continuous improvement/compliance of deviation system. Presents and answers questions about deviation systems and processes to Catalent Management, regulatory inspectors and customers
- Provides guidance and appropriate oversight for the commissioning and qualification of new equipment, instruments, including major capital projects and computer systems
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