Associate, QA Resume Samples

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D Dickens
407 Kutch Ports
+1 (555) 711 5969
407 Kutch Ports
p +1 (555) 711 5969
Experience Experience
10/2016 present
Philadelphia, PA
Associate QA Compliance Specialist
Philadelphia, PA
Associate QA Compliance Specialist
10/2016 present
Philadelphia, PA
Associate QA Compliance Specialist
10/2016 present
  • Maintaining electronic systems used for Change Control and Deviation Management
  • Actively participate in continuous improvement initiatives
  • Identify gaps in systems and develop feasible plans for correction
  • Quality Risk Management
  • Responsible for review and approval of the following types of documents, relating to area functions
  • Administration and oversight of site quality systems including but not limited to
  • Participates in quality risk assessments
04/2014 04/2016
Phoenix, AZ
QA Project Associate
Phoenix, AZ
QA Project Associate
04/2014 04/2016
Phoenix, AZ
QA Project Associate
04/2014 04/2016
  • Each employee is to practice teamwork and lateral service to create a positive work environment
  • Each employee will understand his or her work area and goals as established in the strategic plan
  • Create the Quarterly Quality Newsletter, providing updates on QTF and other quality initiatives
  • Manage Electronic Quality Initiatives, such as LIMS, EQMS, and MODA
  • Provide Quality Assurance related support to various departments
  • Managing multiple cross-functional project teams simultaneously and reporting projects status to management
  • All employees are to know their roles during emergency situations and are aware of fire and life safety response processes
12/2010 10/2013
Detroit, MI
Associate QA Analyst
Detroit, MI
Associate QA Analyst
12/2010 10/2013
Detroit, MI
Associate QA Analyst
12/2010 10/2013
  • Work in collaboration with the QA team to make continuous improvements to testing coverage and reduce testing cycle time
  • Manage the quality assessment of individual associates and recommend performance action plans for associates who are not meeting established standards
  • Manage Project Management Office sharepoint portal Administration of Workfront
  • Plan, create, execute and maintain automated test scripts for Regression testing, Smoke testing and Functional testing
  • Develop, document and maintain functional test cases and execute test scripts
  • Work with the development team to understand the effect of the project changes on automated test scripts and maintain scripts accordingly
  • Learn Project and portfolio Management tool Workfront and become the tool adminstartor
Education Education
Bachelor’s Degree in Life Sciences
Bachelor’s Degree in Life Sciences
Central Michigan University
Bachelor’s Degree in Life Sciences
Skills Skills
  • Strong attention to detail with good organization skills and ability to exercise independent judgment
  • Ability to initiate quick follow-up actions and to perform duties with a great deal of latitude for independent judgment
  • Support implementation of DevQA Quality Plan, track deliverables and assure owners meet implementation/deliverable deadlines
  • Highly proficient in Microsoft Word, PowerPoint, Excel, Adobe Connect, Sharepoint, Concur, Ariba and Outlook
  • Strong understanding of Novartis Organizational policies and procedures; and able to work with international colleagues
  • Able to deal with high-level contacts and exposure to sensitive information/
  • Collect, store and maintain all auditable documentation as per Novartis internal standards
  • Capable to handle multiple tasks concurrently with tight time schedules by appropriate self-prioritization of work with minimal supervision
  • Support data gathering and compilation of information for Quality Review Boards
  • Generate reports from AQWA Audit and AQWA Quality Events
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Cib-is QA-selenium, Unix-associate Resume Examples & Samples

  • Experience working in Agile, Incremental & Iterative, Scrum, XP, or Lean environment
  • Strong experience with use of Automated test tools (eg: Selenium, JBehave, Cucumber)
  • Performance and capacity testing experience a plus
  • Exposure to Test Driven or Behavior Driven Development a big plus

Cib-investor Services QA Usbd-associate Resume Examples & Samples

  • Provide end to end testing solutions to complex data migration initiative with tight deadlines
  • Effectively manage testing cycle for changes to complex suite of applications as part of migration project
  • Develops and implements test strategy, test plans and tools in tandem with requirements and industry standards
  • Test management and defect management using HP ALM
  • Strong knowledge on Software Testing Principles and understanding of testing methodologies
  • Strong Experience in Test management and defect management tools like HP ALM
  • Strong experience in preparing Test Strategy, Test Plans, Test cases, Test Execution Schedules, effort estimates, Test reports, Defect Reports and other artifacts as required for end to end test execution
  • Experience in Test Management Systems like Quality Center/ALM
  • Experience in banking/financial domain is a plus
  • Strong knowledge of Relational Database(Oracle) with ability to write complex SQL Queries independently
  • Strong Unix Shell scripting skills
  • Strong exposure to any of the job schedulers like Autosys/IBM Tivoli/ Control M
  • Experience in Testing ETL( Informatica workflows)
  • Experience in Business Objects reporting tool ( create adhoc/canned reports independently)
  • 6 - 8 years software quality assurance experience

QA Functional Test Engineer Associate Resume Examples & Samples

  • As subject matter expert of the T24 application, provide functional guidance to the team and ensure test cases are appropriately detailed and are scheduled in an efficient manner
  • Review and identify regression impacts of related functional changes and ensure that they are documented and incorporated in the automated regression test suite
  • Become SME for the T24 application, understanding the database and build out SQLXML repository to effectively exercise and validate the application
  • Excellent test analysis and design skills, with demonstrable experience in designing test conditions using coverage test techniques such as decision tables and pair wise testing
  • Demonstrable experience of using configuration management tools for managing test assets such as Subversion

QA Senior Automation Engineer Associate Resume Examples & Samples

  • Designing and building of automation scripts, writing complex SQL\XML queries and building and managing test data for interfaces and core functional processing of the T24 application
  • Implement, provide insights into best practice, maintainability and standards for the Rational Test Workbench automation suite for the T24 Application
  • Produce and deliver training and knowledge transition material for all joiners within the team
  • Become SME for the T24 application, understanding the database and build out SQL\XML repository to effectively exercise and validate the application
  • As subject matter expert, provide technical guidance on Rational Test Workbench and configuration management and data management techniques and best practice
  • Manage the automation test environment with AD, including the release scheduling, backup and restore and configuration changes
  • Must have 6+ expert automation experience of Greenhat Tester or IBM Rational Test Workbench automation test tool
  • Strong credentials in delivering data driven approach for automation for functionally complex message based applications preferably in the banking domain
  • Strong SQL Programming experience XMLSQL skills for interrogating CLOBBLOB xml payloads
  • A self learner who can quickly grasp and use this knowledge effectively in forwarding key automation deliverables
  • Strong configuration management skills and usage of products like subversion for managing all test automation assets and data
  • Experience of defect management process

QA & Methodology Associate Resume Examples & Samples

  • Experience of working in a global organisation
  • Qualified Accountant preferred
  • Financial Services experience preferred
  • Internal Audit experience preferred

Associate QA Resume Examples & Samples

  • The Quality Assurance Associate will be required to work closely with the line of business controllers, finance and operations areas to understand and evaluate the firm’s data quality and reporting processes
  • Perform substantive testing and evaluation of balances and other information (based on transaction nature and underlying client/contractual information) in support of the Quality Assurance agenda
  • Execution of Quality Assurance reviews across CCB specific deliverables including
  • Identifying and reporting on noted errors, logging issues for appropriate action plan development and resolution, providing recommendations and lessons learned
  • Experience & Skill Set

QA Senior Associate Digital Experience Center Hallandale Resume Examples & Samples

  • Designing, scoping, and facilitating test plans and test cases based on user requirements and functional specifications, including verification of functionality, performance, security, and scalability
  • Writing and executing user acceptance criteria, test plans, file bugs, and communicating with the team about issues, especially interacting with Project Managers and developers to triage inbound bug reports and reproduce reported issues
  • Continuously streamlining and improving the testing life cycle to establish that test planning, execution, and reporting are effective and coordinated, including end-to-end automated test coverage
  • Conducting functional and unit testing, as well as code writing and programming
  • Testing web services and consumer-facing web applications, utilizing Sitecore, Ektron, Adobe CQ5, TFS, and Selenium
  • Performing load and stress testing in .Net based infrastructure

Associate, QA Doc Resume Examples & Samples

  • Issue control documents for production and manufacturing
  • Participating in record lifecycle management and document archiving
  • Provide Quality Assurance representation and guidance at Technical Transfer meetings for manufacturing campaigns
  • Collaborating closely with manufacturing and production, rest of QA and QC organisation
  • Participating in ad-hoc departmental projects (process improvement projects, contributing to global corporate challenges)
  • Minimum 3-5 years’ experience in a regulated environment
  • Knowledge of Data Management System and Product Lifecycle Management System (eArchival/back up systems)
  • Experience with a transition process from a paper to an electronic documentation system (preferred)
  • Advanced IT skills and excellent verbal and written skills in English
  • Good Manufacturing Practices (cGMP) and Quality systems is an advantage as well as experience with project management and Lean Six Sigma

Senior Associate, QA Operations Resume Examples & Samples

  • Reviews batch records, QC testing records, and all supporting records
  • Provides technical assistance and training for personnel
  • 3+ years of relevant work experience in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilities

Associate Director, Development QA, Biologics Resume Examples & Samples

  • Member of CMC Development Teams providing Quality input from Phase 1 through late Development and Product commercialization
  • Partners with Technical Operations and Pharmaceutical Development to develop and implement the Pharmaceutical Development strategy for new drug candidates. Partners with Technical Operations and Pharmaceutical Development to identify and qualify manufacturing facilities for the Development, Manufacture, Testing and Packaging of Clinical product (Bulk Drug Substance and Drug Product), and ensures Quality Agreements are in place for Clinical Supply. Key member of the Quality Audit Team/partners with GMP Compliance Audit
  • Responsible for product change management through the development process to include impact assessments, tracking and implementation to ensure a compliant fileable product and process is developed
  • Track/Own ongoing regulatory updates to Health Authorities (e.g. IND/BLA) from a quality perspective including specifications, shelf life extensions, country specific trial approvals etc
  • Works with CMC Teams to conduct risk assessments for all aspects of the Development Process and Supply chain
  • Final Quality approver for all GMP documentation associated with the Development and Validation of the Product to include Manufacturing and Testing Methods, Specifications, Stability Protocol and Reports, and Validation Protocols and Reports
  • Responsible for Quality input for CMC sections of the IND/BLA and the final Quality Review prior to filing
  • Thorough knowledge of the Pharmaceutical Development Process as evidenced by bringing multiple INDs through to successful BLA approval
  • Knowledge of bulk biologic drug substance (monoclonal antibody, etc.) and Parenterals (cold chain liquid/lyophilized form) would be considered an advantage
  • Understanding of Health Authority expectations relative to CMC Development as well as Clinical Trial supplies
  • Extensive experience in the quality management of outsourced operations (i.e. contract manufacturing organizations)
  • Good Knowledge of CMC Regulatory Affairs for development
  • Scientific degree in life sciences and/or bio-engineering. Advanced degree in these fields would be considered a significant advantage

Senior Associate, QA-compliance Resume Examples & Samples

  • Maintains an efficient audit and corrective action tracking system and develops detailed audit plans
  • Conducts comprehensive internal and external audits in accordance with written procedures to verify the adequacy and effectiveness of procedures and processes. Prepares detailed written audit reports
  • Assists in developing recommendations for corrective actions/improvements and establishing timelines
  • Performs Corrective Action follow-ups ensure timely completion of corrective actions and evaluates the effectiveness of corrective actions
  • Hosts customer audits. Prepares document requests in accordance with customer audit agenda
  • Collaborates with internal departments to ensure effective customer audit responses/corrective actions are generated in a timely manner
  • Performs Corrective Action follow-ups to ensure that commitments to our clients are completed as agreed in the customer audit response
  • Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis
  • Conducts cGMP audits including audit preparation, execution of the audit, the audit report, and follow up to any findings
  • Writes detailed reports and analyzes quality data. Generates quality systems metrics for management review
  • Creates, revises, and reviews SOPs. Maintains GMP environment and follows SOP’s
  • Processes compliance documentation initiation, revisions, and deletions
  • Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
  • Performs logbook documentation audits for cGMP regulated logs and SOPs

Associate QA Analyst Resume Examples & Samples

  • Under the guidance of QA Manager
  • Develop Test Plan for small projects
  • Develop, document and maintain functional test cases and execute test scripts
  • Develop traceability between functional requirements to testing
  • Assist the QA Manager with creation of test metrics during SIT and UAT phases
  • Learn Project and portfolio Management tool Workfront and become the tool adminstartor
  • Manage Project Management Office sharepoint portal Administration of Workfront
  • Develop the bi annual IT newsletter
  • QA Tools (HP Quality Center & Unified Functional Testing Tool)
  • Assist the QA Manager with roll out of new tools/ processes
  • Assist QA Manager with setup activities for test automation
  • QA Auditing
  • Conduct Quality Audits for projects and report to the management
  • Assist the project manager and the team with Harman specific QA standards, practices and operating procedures
  • Collect all the testing related deliverables from the project and store them in a common repository for reuse
  • 1 year of work experience or internship in Software Testing/Project Management domain
  • Bachelors Degree in IT, Infomatics, Computer Science, Engineering, Communications, or other technology related program
  • Familiarity with QA Processes and concepts
  • Demonstrated communications skills
  • A global perspective with the ability to understand and work effectively in a culturally diverse organization
  • Ability to communicate in a virtual environment, in virtual teams, using both conference calling and Webex technology and effectively with stakeholders and IT leadership
  • Ability to creatively solve problems
  • Ability to organize and work effectively with cross-functional teams from various departments and international locations
  • Strong familiarity with collaboration and communication software, such as Microsoft SharePoint, Office, and Outlook
  • Strong knowledge of MS Excel

Senior Associate, QA Training Resume Examples & Samples

  • General site administrator and Subject Matter Expert in the ComplianceWire Learning Management System (LMS) application
  • Write / edit LMS procedures and job aids
  • Conduct training needs assessment to determine training requirements
  • Work with functional management to design training including job specific tasks, SOP training, FDA cGMP, Health and Safety, HR, leadership, interpersonal skills and general work skills as needed
  • Support technical new hire on-boarding from orientation through first 90 days by presenting orientation sessions as needed and assisting hiring supervisors with development of 30-60-90 day training plans
  • Facilitate classroom training including new hire and annual training
  • Support design and development of department on-the-job training
  • Develop qualifications / evaluations to ensure training effectiveness
  • Develop and maintain training items and curricula in the LMS
  • Facilitate meetings for annual department curriculum review
  • Review training records for accuracy and completeness
  • Provide formal and informal training and guidance on use of the LMS
  • Update and maintain the LMS application
  • Interface with auditors / customers regarding LMS
  • Track/monitor training and provide timely, accurate information including metrics to management for actions needed to ensure compliance
  • Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science; or
  • Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 3 years’ of related experience; or

Senior Associate / Associate QA Resume Examples & Samples

  • Review of executed production batch records, specifications, and SOPs
  • Conduct QA on the floor duties including but not limited to; line clearance, real time documentation reviews, spot audits
  • Represent QA on various projects and support activities associated with manufacturing, testing and release of product
  • Support activities related to qualification/validation of equipment and processes
  • Revise quality systems procedures as required to maintain a state of compliance with cGMP regulations
  • Participate in internal audits
  • Contribute and support site PAI and commercial readiness preparations
  • Ensures that the quality assurance programs and procedures are adhered to and followed to ensure compliance to cGMP regulations and ICH guidelines
  • Perform other QA responsibilities as assigned by management
  • 5+ years in the drug/device pharmaceutical industry in QA GMP functions preferably for combination aseptic products in clinical studies (Phase I to III) commercial
  • Leads by example and highly collaborative with the proven ability to work in a cross-functional team
  • Strong verbal, written communication skills and computer skills are required

QA / Client Service Associate Resume Examples & Samples

  • Provide client support with oversight from Leadership
  • Assist with product implementations and day to day client services of multiple accounts, removing roadblocks, direct client questions to the appropriate parties, managing conflicting priorities amongst customers, and coordinate implementation project plan as requested
  • Maintain positive client relationships at the appropriate levels
  • Assist in growing and expanding relationships as represented by significant revenue growth per year
  • Provide support in order to position both client and LN for strategic growth. Responsible, along with Leadership, for customer satisfaction
  • Assist in planning and the continuous improvement of development and project processes. May identify key service trends
  • Work hand in hand with sales to strategically assist and identify top customer needs
  • This role requires someone to be solution oriented and to make the customer's effort as seamless as possible
  • Bachelor degree in business, computer science or related field
  • 3-5 years of recent related experience in Customer Service, preferably within the healthcare industry
  • Knowledge of current IT tools and process disciplines preferred
  • Understanding of project management to include demonstrated project management skills
  • Understanding of technology directions and trends helpful
  • Ability to plan, manage and deliver tactical projects deliverables
  • Ability to built customer relationships and continually monitor customer satisfaction within designated accounts
  • Suggest opportunities for service improvement leading to increased customer satisfaction
  • Strong computer skills, Word, PowerPoint, Excel and Visio

Associate QA Analyst Resume Examples & Samples

  • Test from existing test cases
  • Write test cases against new functionality using acceptance criteria and user stories
  • Report defects with accuracy and detail
  • Work with the development team on resolving bugs
  • Meet project timelines
  • Learn Quality Assurance best practices
  • Adhere to testing formats and tools as set by Quality Assurance leadership
  • Proactively solve issues encountered while testing
  • Develop understanding of programming logic basics
  • Bachelor’s degree in computer science, engineering, or math or equivalent experience in testing and troubleshooting accepted
  • Knowledge of writing test plans, creating test cases, and debugging
  • Experience with object oriented software development and related paradigms
  • Experience working in an agile/scrum team
  • Knowledge of web and mobile device technologies

QA Complaint Specialist Associate Resume Examples & Samples

  • Receives complaint information from Corporate Quality Complaint Operations
  • Documents product complaint information employing good documentation practices and coordinates the investigations into the root cause of the complaint(s)
  • Transfers and tracks files (hard copy and electronic) both inside and outside department. Stores each completed complaint record for product manufactured at the Salt Lake
  • Facility, as required by FDA regulations
  • Receives customer complaint samples including controlled substances
  • Distributes the samples for evaluation by the appropriate department and tracks sample location as required by DEA regulations. Maintains complaint samples in a secure location for the required retention period and disposes of them in compliance with company and government policies
  • Creates and supports monthly, quarterly and yearly trending reports and other reports as required by SOP or as needed. Compiles, analyzes, and summarizes data from various databases, reports and other sources. Provides project support as needed
  • Working with departments such as Corporate Drug Safety, Corporate Quality Complaint Operations, ensures complaint investigations are correctly carried out to completion in a timely manner. Follow up on inquiries as needed to complete the investigation
  • Compiles and reports metrics such as Monthly complaint through-put and closure rate to site and corporate management
  • Monitors trends in complaint data through daily complaint handling. Because of the daily exposure to different complaints, plays an integral part in early identification of trends. Reports significant changes to management
  • Performs general office duties including: reports distribution, filing, memo creation, maintaining complaint file tracking system and complaint samples
  • Current Good Manufacturing Practices and Food and Drug Administration regulations and requirements
  • Business English usage, spelling, grammar and punctuation
  • Current Company policies, practices and procedures, including safety rules and regulations
  • Ability to identify trends in a given data set
  • Communicating clearly and concisely, both orally and in writing
  • Managing multiple projects, duties and assignments
  • Establishing and maintaining cooperative working relationships with others
  • Ensuring compliance with all Company policies and procedures, including safety rules and regulations

Senior Associate, QA Operations Resume Examples & Samples

  • Reviews ancillary facility and equipment records in support of GMP operations
  • Reviews assay qualification, equipment, and stability protocols
  • Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 3 years’ related experience; or

Associate Director West Point QA Resume Examples & Samples

  • Responsible for direct Quality Risk Management (QRM) Site deployment
  • Accountable for planning, leading and coordinating activities involved in the design/development, implementation and governance of a harmonized Quality Risk Management program including standards, business processes, tools and training for the Site
  • Responsible for partnering with customers across Site, key stakeholders and management, to communicate/escalate and ensure timely and adequate management of quality risks
  • Responsible for Site implementation of business processes for integration of Quality Risk Management into relevant elements of the Pharmaceutical Quality System (PQS)
  • Able to travel as needed to support understanding of Divisional deployment requirements
  • QRM Program Design input to Divisional Quality and West Point Site Deployment
  • Implement QRM program for the West Point Site
  • Develop and implement site QRM business processes in alignment with the QRM CoE program, including integration into QMS
  • Quality Risk Reporting and Communication to the Site and potentially above site
  • Manage site quality risk log/register & report site QRM metrics and status to the site, and appropriate global groups
  • Ensure Site Risk register is maintained
  • Develop and implement risk escalation model at the Site in alignment with the QRM CoE program
  • QRM Expertise & Facilitation
  • Provide leadership, QRM expertise and facilitation QRM activities at the Site
  • Accountable for execution/facilitation review/approval of site level QRM activities
  • Ensures schedule based risk reviews occur
  • QRM Training Program implementation at the Site
  • Ensures that all those involved in QRM activities are trained per the QRM CoE training plan
  • Use of and support of the QRM IT Tool Implementation at the Site
  • Fast learner and can be a change agent
  • On the floor manufacturing shop experience
  • Demonstrated self starter with capability to develop innovative solutions to challenges

Senior Associate, QA Resume Examples & Samples

  • Perform timely QA review and approval of batch documentation for drug substance through assessment of the process parameters, solution lots, and batch production records utilized during batch manufacturing
  • Perform review and approval of documentation, deviations, CAPA etc. in connection to batch disposition
  • Provide input to QA and LSM Manufacturing management regarding issues with the manufacturing process and/or batch documentation that could delay or prevent timely release of drug substance
  • QA and/or manufacturing experience from the pharmaceutical industry
  • Solid knowledge of GMP and quality systems
  • Strong English communication skills
  • Positive and pragmatic attitude with focus on priorities and delivery on time

Associate, QA Product Release Resume Examples & Samples

  • Review and approve executed manufacturing batch records
  • Reviews/audits all data obtained during quality assurance activities to ensure consistency with company policies and procedures (completed batch records, in- process test results, AQL attribute inspection, etc.) necessary to release batch
  • Investigate errors, and implement corrective actions
  • Review and/or approve lab test results (SQARs)
  • Initiates Hold Notification
  • Initiates NCR (Non-Conformance Report) and coordinates with Manufacturing, Warehouse and Material Management
  • Reviews investigations
  • Writes, reviews, approves company GMP-related SOPs
  • Prepare documents for shipment
  • Communicates with clients regarding batch release questions and documentation
  • Follow up with other departments (Technical Services, Manufacturing , Quality Engineer, Planning, etc.) for batch related questions

QA Analyst, Associate Resume Examples & Samples

  • Work with the project team to analyze project/product requirements and testing needs in order to create and execute a comprehensive test strategy including both functional and technical/system-level testing
  • Actively participate in software requirements, design, and code reviews to provide early and continuous quality feedback
  • Help troubleshoot and verify bugs and errors reported
  • Work effectively with members of the project team to ensure project success and champion high quality throughout the project

CPO Development QA IMP Associate Director Resume Examples & Samples

  • 10 or more years of experience in the pharmaceutical industry with direct experience with Compliance and Quality Systems
  • Experience in drug development, clinical, manufacturing, outsourcing and/or other relevant operational areas, but must include minimally 5 years in QA
  • Strong communication and leadership skills. At least 5 years’ experience leading teams in a highly regulated environment
  • Thorough knowledge of GMP requirements
  • Strong understanding of regulatory requirements for Quality Systems

QA Clearance Associate Resume Examples & Samples

  • GMP and Part 11 compliance knowledge preferred
  • Computer software skills including Microsoft Office
  • Skills: Database and spreadsheet creation and
  • Written and oral communication skills; listening skills
  • Independent and self-directed

Senior Associate QA SW Engineer Resume Examples & Samples

  • Expert knowledge in developing test scripts using TCL/TK,EXPECT / iTEST for L2/L3 protocols testing
  • Should be able to develop and maintain tools /scripts for automated regression testing for carrier class routers /switches
  • Work with SQA and development teams to capture and integrate automated Test Cases in to the test harness,
  • Run regression testing for major/minor releases and conduct failure analysis, isolate and fix script/harness issues
  • Real-time embedded platform bring up testing
  • Testing of 10/100/1000 and 10G Ethernet interfaces
  • Bridging/Spanning Tree, VLANs (all types), QoS (classification, modification, and policing), IEEE 802.1P, Access Control, Link aggregation, Mirroring, IGMP Snooping, and TCP/IP
  • Good working knowledge on MPLS/VPLS protocols including LDP, RSVP, VPLS, VPWS, MPLS-OAM, MPLS-FRR, MPLS Routing
  • Unicast and Multicast protocols and applications - RIP, OSPF, VRRP, IGMP, PIM, DVMRP, BGP, and IEEE 802.1W
  • Tools development and Test Automation: Tcl/Tk, Scripting
  • Traffic redirection based on L4/L7 port information (TCP, UDP, HTTP etc) or IP address range-both source/destination,
  • NAT, Server Load balancing and Streaming media applications

Associate QA Analyst Resume Examples & Samples

  • Meet with the clinical teams and subject matter experts to gather specifications and understand workflow that will be incorporated into the test scripts
  • Develop testing plans and testing documents, including use case development
  • Maintain the test scripts for unit, system, integrated, and end to end testing for new activations, configuration and build changes, and software upgrades
  • Develop and maintain a traceability matrix
  • Identify application enhancements and changes that require updating in existing test plans and perform those updates in a timely manner
  • Participate in all phases of application and interface testing
  • Assist in coordination of End to End and User Acceptance testing activities. Review test outcomes
  • Enter and update issues in the Issues database, and follow up to resolution
  • Provide 24/7 on-site support during activations and other activities as required
  • Minimum of one year experience with application testing and test script writing
  • Proficiency in using testing tools preferred
  • Experience with requirements analysis and clinical test case/script development
  • Strong communication skills and ability to interact with clients in a healthcare environment
  • Strong technical writing, analytical and problem solving skills
  • Healthcare background preferred
  • Ability to prioritize tasks within the project and work with minimal supervision or guidance
  • Knowledge of Allscripts Sunrise Clinical Manager a plus

Master Associate, QA Resume Examples & Samples

  • Identifies, classifies and reports deviations, as appropriate and typically works on Minor, less complex deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with cross functional team members to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations. Authorized to suspend any operation when the situation warrants and immediately notify Quality Management. Provides guidance and control directives regarding remediation activities required to continue production. Is required to escalate critical issues within area assigned to senior management team based on severity of the issue
  • Provides continuous improvement ideas in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI's Quality Systems. May attend project team meetings to provide QA guidance and oversight to such improvements
  • May be asked to serve as a Subject Matter Expert for internal matters. Participates in inspection readiness activities and is involved in inspections by regulatory agencies

Csdc QA Senior Associate Resume Examples & Samples

  • Assessing and appraising the full lifecycle of a defined Testing Methodology: Development Integration Testing, Automated testing using Selenium, Component/Feature Testing, System Integration Testing, SIT, User Acceptance Testing, UAT, and Production Acceptance Testing, PAT
  • Evaluating end-to-end integrated systems and recommending action plans
  • Providing testing recommendations
  • Providing team leadership and oversight; and,
  • Executing strategic business plans, requirements, and processes
  • Identifying and addressing of client needs: building solid relationships with clients; developing an awareness of Firm services; communicating with the client in an organized and knowledgeable manner; delivering clear requests for information; demonstrating flexibility in prioritizing and completing tasks; and communicating potential conflicts
  • Communicating in an organized, knowledgeable manner in written and verbal formats
  • Providing guidance and best practices to team members
  • Conducting quantitative and qualitative analyses of large and complex data; and,
  • Obtaining and leveraging various certifications-i.e., testing tools, Selenium, Quality Center, et al, SDLC methodology certification, ITIL, et al., Project Management, PMP, Certification and/or utilizing skills involving conducting functional and/or system tests, developing and reviewing test plans and scripts

Contract Associate QA Analyst Resume Examples & Samples

  • Plan, create, execute and maintain automated test scripts for Regression testing, Smoke testing and Functional testing
  • Assist in optimizing and improving QA processes for Test automation
  • Work with the development team to understand the effect of the project changes on automated test scripts and maintain scripts accordingly

Senior Associate QA-aml Resume Examples & Samples

  • Quality experience
  • Basic statistical mathematical skills
  • Basic knowledge of process and facility equipment
  • GMP knowledge with ability to interpret and apply in routine cases
  • Technical writing capability
  • Demonstrated skill in problem solving and providing solutions
  • Ability to interface effectively with various levels
  • Basic understanding of analytical methods used in support of facility process monitoring
  • Ability to work as a team player and/or independently
  • Ability to evaluate documentation/ operations according to company guidelines
  • Intermediate word processing, database, presentation and spreadsheet application skills
  • Skill in prioritizing and meeting deadlines
  • Good communication and presentation skills (both written and verbal)
  • Ability to seek outside resources as needed
  • Basic data trending

Senior Associate QA Resume Examples & Samples

  • QC Lab data authorization in LIMS
  • Perform review of non-conformances and change control records as part of product disposition process. Sampling, inspection, review and release of printed and non-printed packaging components. (Additional) Sampling and Inspection of materials or drug products as needed. Review temperature data of shipments received at ABR. Preparing samples for shipment to testing laboratories. Perform GMP compliance checks in Warehouse. Provide QA oversight for
  • Regulatory labeling in the WH
  • Issues upon receipt of components LDP/ IDP/ FDP/ NAMP
  • Destruction Authorizations
  • Cancelled Ship Confirmed Orders
  • Trainer for IQA related processes. Perform monthly Supplier Performance Monitoring and prepare metrics and own and maintain departmental performance boards. Maintain compliance against corporate SQM standards. Review and approve Packaging Component Specifications. Initiate and own material related class 1 NC’s

Associate, QA-large Scale Manufacturing Resume Examples & Samples

  • Responsible for the scientific documentation for Campaign Segregation and carry over between different drug substances
  • Reviewing documentation for compliance to internal procedures and applicable regulatory and corporate guidance documents
  • Reviewing validation documentation and additional test of protocols and reports

QA Development Associate Clinical Trials & Pharmacovigilance Resume Examples & Samples

  • Implement and maintain the local Quality System in the areas of GCP and GPvP, in accordance with the Novartis Quality Manual, the CPO Quality Plan, and the local regulatory requirements
  • In cooperation with local Regulatory Affairs and Patient Safety, keep abreast of regulatory requirements, and update local management and CPO QA on the possible ramifications of regulatory changes and impact to Clinical Development, MA and PV processes
  • Report monthly Key Quality Indicators (KQIs) related to development activities to CPO QA and monitor them and assure that gaps are addressed appropriately in order to mitigate risk
  • Partner with Pharma Development QA in the preparation, execution and follow-up of audits on clinical development activities. Coordinate answers of the auditees, provide guidance in determining country observations root causes and ensure that appropriate corrective and preventive actions are implemented on all major and critical audit findings
  • In cooperation with the local GMP QA Unit ensure analysis, assessment and resolution (including CAPAs where indicated) of issues with common interfaces
  • Ensure that deviations, incidents and HA inspection actions are properly managed in AQWA and that escalation is performed when required
  • Ensure, where appropriate, interface/communication with authorities for any GCP/GPvP related activity (e.g. local Health Authority [HA] inspections)
  • Ensure CPO readiness for GCP and GPvP regulatory inspections
  • Provide support prior to, during and after HA inspections of the CPO, investigational sites or external service providers, as applicable, together with the Novartis inspection lead. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant CAPAs have been completed/closed in due time
  • Together with Local Leadership Team members, ensure conduct of adequate training at the CPO for GCP and GPvP activities by defining, planning and supporting training activities
  • Ensure that the Clinical and PV computerized systems are assessed using Risk Assessment for GCP and GPvP relevance to enable their validation where required
  • Support Clinical Operations, Medical Affairs and Pharmacovigilance associates with quality related issues and provide guidance when necessary
  • Set up and execute quality assessments/self-inspection activities (TMF review, investigator site visits…) in the CPO/Investigator sites using a risk-based approach to improve quality of the overseen activities
  • Significant number of years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, registration, clinical development or a directly related area

QA Operations Senior Associate Resume Examples & Samples

  • Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science
  • Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 3 years’ related experience
  • Associate’s Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 4 years’ related experience

Associate, QA Document Control Resume Examples & Samples

  • Maintain, process, and shepherd all documents, production, training, equipment, and facility records for all GxP operations through their respective lifecycles on a daily basis as assigned and according to work instructions and SOPs
  • Create/issue/maintain controlled forms, logs, lot numbers, work instructions, log books, document numbers, labels, etc. (including but not limited to SOPs, protocols, methods, reports, batch records, specifications, drawings, validation plans, and maintenance logs)
  • Update templates and work instructions when necessary; proactively apply standards and ensure consistency across all controlled documentation
  • Meticulously track and file all controlled documentation using multiple linked trackers and pivot tables
  • Maintain QADC supplies and QADC equipment (reporting issues to IT, Facilities, etc)
  • Support all QMS activities (CAPA, DRs, OOS, etc) in hardcopy and electronically, including document control, training management, processes, and troubleshooting/user support
  • Scan all controlled document records and maintain up-to-date and accurate metadata in EDMS-ready PDFs; assist with the migration effort from paper to electronic systems, as required
  • Assist with the maintenance of secure on- and offsite record storage processes and procedures, including efficient and accurate retrievability and inventory controls
  • Good knowledge of US and EU regulations
  • At least 6 years of hands-on Document Control experience (a combination of manual and electronic systems is preferred)
  • Strong communication skills allowing for close, clear, and continuous communication (in person and via email) with interfacing departments
  • Strong attention to detail and expert editorial skills
  • Strong proficiency in MS Office suite (especially Word and Excel) and Adobe Acrobat Pro (skills test will be administered)

Investigations Associate QA Resume Examples & Samples

  • Initiate, track monitor, facilitate closure, and QA review of deviations, investigations, out of specification (OOS), and out of trend (OOT) reports for compliance to FDA regulations and other guides/guidelines
  • Author QA deviations/investigations
  • Provide cGMP guidance to functional groups such that all discrepancies are closed within defined timeframes
  • Issue reports of all open non-conformances and track completion/closure
  • Manage CAPAs to ensure timely closure of actions resulting from various types of investigations from the QC laboratories
  • Provide metrics to track/trend non-conformances and recommend additional actions to prevent reoccurrence
  • Assist during regulatory inspections or other audits as required
  • Provide training to function areas on compliance issues
  • Proficient with computer programs. TrackWise experience preferred

Associate QA Analyst, Business Systems Resume Examples & Samples

  • Familiarity on manual testing for any of Aptean products
  • Knowledge on full software development life cycle and software engineering best practices
  • Knowledge on Agile /Scrum team

Associate Call QA Specialist Resume Examples & Samples

  • Minimum of 1 year of recent and related direct customer service experience (call center) required
  • Experience with Windows-based software applications required
  • Recent and related phone quality monitoring experience preferred
  • Experience in providing constructive feedback and serving as a training resource, mentor and coach preferred
  • Experience with Verint call monitoring system preferred

QA Documentation Associate Resume Examples & Samples

  • Support QA Manager in a QA Documentation role by ensuring that the proper company SOPs are followed
  • Maintain adherence to SQF/HACCP standards and prepare regulatory documentation
  • Perform other tasks as required by QA Manager

Senior Associate, QA Change Control Resume Examples & Samples

  • Provide QA oversight of change control documentation including; review and approval of change requests, tracking of implementation requirements, and managing documents supporting the change control process
  • Ensuring all proposed changes adhere to company policies/procedures and GMP regulations and are reviewed by applicable stakeholders
  • Provide status reports, including relevant metrics, to department management and follow up on open change requests to ensure timely completion
  • Provide QA oversight of manufacturing product changeover and shutdown activities, which includes gowning required to enter manufacturing areas
  • Facilitate cross functional meetings to ensure proposed changes are communicated to and discussed by relevant stakeholders
  • Represent the change control program in internal/external audits and regulatory inspections
  • Ability to comprehend technical information related to changes and regulatory expectations
  • Working knowledge of United States and European regulatory requirements, guidelines, and recommendations for change control
  • Exhibited proficiency working within quality systems
  • Ability to lead cross-functional initiatives to completion
  • Ability to successfully communicate with representatives from all levels within the organization
  • 6+ years of experience in a GMP regulated environment
  • Exhibited proficiency working within change control systems
  • Understanding of Ex-US and European regulatory guidelines
  • Experience with TrackWise Quality Management System
  • Experience and proficiency with standard office software applications, including MS Word, MS Excel, MS Project, and MS Powerpoint

Associate QA Analyst Resume Examples & Samples

  • At least 1-2 years of QA experience, preferably in testing e-commerce websites, web-based projects and mobile projects
  • At least 1-2 years of experience in developing automation test scripts using Webdriver based frameworks
  • At least 1 year of experience with Javascript is required
  • Knowledge of version control system - GIT is required
  • Knowledge of behaviour driven testing (e.g. Cucumber) is an asset
  • Knowledge of bug tracking software (preferably JIRA) is required
  • Knowledge and experience in various types of testing (Functional, Regression, Browser compatibility, Integration, System, Configuration, Smoke, Accessibility, etc.) is an asset
  • Ability to work as part of a team with good work ethics

QA Project Associate Resume Examples & Samples

  • Organizing and leading all project communications/meetings, including recording meeting minutes, tracking action items, preparing meeting agendas, coordinating internal team activities and disseminating project information
  • Identifying issues that may delay project and recommending appropriate risk mitigation strategies, contingencies, and actions to be taken
  • Ensuring team members understand project objectives, specifications, deliverables, timelines and tasks through ongoing clear, concise communication & motivation of project team members
  • Collaborating with and providing ongoing project updates to Quality Management and Functional Directors to assure integration of project, company, and functional goals towards achieving project milestones and timetables
  • Managing multiple cross-functional project teams simultaneously and reporting projects status to management
  • Support update/review the associated SOPs related to QTF, as needed
  • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
  • Manage Electronic Quality Initiatives, such as LIMS, EQMS, and MODA
  • BS Degree in biological sciences or equivalent
  • Sound knowledge of aseptic processing and supporting technologies

Associate QA-incoming Resume Examples & Samples

  • Intermediate mathematical skills
  • Experience with lab equipment
  • Basic understanding of cGMPs
  • Clear, concise writing skills
  • Ability to interact constructively with peers
  • Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles
  • Ability to evaluate documentation and operations according to company procedures
  • Basic word processing, presentation and spreadsheet application skills
  • Demonstrate the ability to prioritize and meet deadlines
  • Good communication skills (both written and verbal)
  • Independently understand, follow and implement basic instructions
  • Demonstrate the Amgen Values

Associate QA Analyst Performance Testing Resume Examples & Samples

  • Performance Test Analyst will be part of the Automation Core team within the CoE
  • The position involves understanding performance testing approach, test plans and contribute in executing plans via test script creation and execution and maintaining status for projects
  • This Analyst will collaborate very closely with various cross-functional project teams to fulfill their performance test requirements
  • Understand and effectively analyze functional requirements
  • Understand test strategy, test plan and contribute in executing the same
  • Prior knowledge of Load Runner and Performance Center will be an added advantage
  • Work with cross functional project teams throughout the full test lifecycle i.e. getting performance requirements, writing scripts, reviewing scripts, executing scripts, analyzing result, test reporting and test closure
  • Coordinate with users/ application team for performance testing requirements
  • Design, develop and maintain effective reusable enterprise wide solutions for performance testing
  • Report status of performance testing engagements to relevant stakeholders and raise issues/risks in a timely manner
  • Support in defining processes and best practices for performance testing
  • Ensure effective utilization of the quality tools for performance testing, co-ordinate with other Testing Teams
  • Ensure compliance to Eaton standard processes
  • Bachelor’s degree in Engineering / Masters in Computer applications with about 2-4 years of QA experience in Performance Testing
  • Strong experience in using and maintaining various frameworks for performance testing,
  • Experience in performance engineering and tuning
  • Must have very good communication and interpersonal skills with experience of direct stakeholder involvement

Associate Director, Development QA Resume Examples & Samples

  • Member of CMC Development Teams providing Quality input from pre-clinical to NDA filing. Partners with technical SMEs to develop and approve the CMC strategy for new drug candidates
  • Final Quality reviewer/approver for GMP documentation; including analytical related documents (Testing Methods, Specifications, Method/Stability Validation Protocols and Reports)
  • Responsible for change control management through the development process to include impact assessments, tracking, and implementation. Also, responsible Quality member for oversight of all key Quality Systems associated with the development candidate including Change Controls, Deviations, CAPAs, and Complaints
  • Work with CMC Teams to conduct risk assessments, as required, for all aspects of the drug development process. Responsible for providing Quality risks to the CMC sections of the IND/NDA
  • Track/Own ongoing regulatory updates to Health Authorities (e.g. IND/NDA) from a quality perspective including specifications, shelf life extensions, country specific trial approvals etc
  • Thorough knowledge of the Pharmaceutical Development Process as evidenced by bringing multiple INDs through to successful NDA approval. Knowledge of multiple pharmaceutical dosage forms (Solids /Parenteral etc.) would be considered an advantage
  • Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH)
  • Recognized as a CMC expert (in relevant area) with an ability to introduce best practices into the CMC Development Process
  • Excellent investigational and QA problem solving skills. Analytical mind, ability to assess new situations in order to define and implement the appropriate QA action plan
  • Work independently, yet effectively in a team environment
  • Strong attention to detail, excellent verbal and written communication skills
  • Teamwork oriented and ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory)
  • Minimum of B.S. degree preferably in Chemistry, Pharmacy, or similar scientific field. An advanced degree in these or a similar scientific field will be an advantage
  • Minimum 15 years of experience in GMP environment of Rx Drug Development (CMC activities). Prior experience in Quality is preferred

Portfolio Management Analytics QA Equity Analytics & Optimization Validation Associate Resume Examples & Samples

  • Factor analytics
  • Portfolio construction (rebalancing, backtesting)
  • The candidate will also have responsibilities on a daily basis to a range of areas
  • Develop and extend independent validation tools which are used to ensure accuracy for all numbers produced by our analytics engines
  • Analyze and extend the analytics regression tests to ensure the complete and efficient coverage for all analytics engine statistics and asset types
  • Work with the Research and Analytics Development teams to evaluate manual and regression test differences, check requirements, and extend test case coverage
  • Ensure that all daily test processes are completed successfully and resolve problems with the assistance of the research and development teams
  • On the job experience with Matlab/R, Python
  • Some level of experience with other programming languages is a plus: Java, SQL, shell scripting
  • Familiarity with version control (Git) and issue tracking (JIRA)
  • Must be willing to work in a global team environment
  • Strong written and oral proficiency in English

Associate Director Clinical Operations QA Resume Examples & Samples

  • Collaborate with Business partners, other Global Development Quality (GDQ) groups and Country QA to ensure International Council Harmonization (ICH)/GCP requirements are fully met
  • Ensure identified quality and compliance gaps are addressed including but not limited to
  • Effective implementation of the new monitoring process (e.g. FOM@N, Risk-based monitoring, etc.)
  • Lead or Co-Lead Quality and compliance initiatives as required and assigned to GDD, (STRIDE, TMF Governance, RBM teams, etc.)
  • Clinical Development Quality Operations participation in respective EDO External Relationship Management Teams (ERMTs), based on functional QA expertise. Leads or Co-chairs the joint quality council
  • The design and implementation of quality/compliance activities and strategic process improvement
  • Contribute to and monitor the implementation of the Quality Plan pertaining to GDO deliverables and ensure delayed activities have a rational and appropriate escalation
  • Support inspection readiness activities, other GDD Quality groups, Country QA, and Group Compliance and Quality by maintaining a state of inspection readiness within GDO
  • Supports quality oversight/management of external service providers and their respective functions/ services. Participates in the oversight and governance of External Service Providers (ESPs) in External Relationship Management Teams (ERMTs) /EDO
  • Provide quality oversight by
  • Escalation of deviation/incidents to ensure adequate and timely escalation of issues to GDD, GDO, and GDQ
  • Providing functional Quality oversight for deviations/incidents ensuring robust investigations, root cause analysis and corrective actions
  • Liaise with GDQ Audit group for external audit planning and provide adequate support for audits and CAPA follow-ups
  • Supporting the business to implement a self-assessment/self-inspection process on defined Global Development Operations (GDO) activities
  • Participating in the development of respective training materials and their delivery in internal business functions
  • Identify ways to continuously improve quality and compliance with regulations & company policies/procedures through partnership with Global Drug Development (GDD) and Global Development Quality (GDQ) groups
  • Contributing towards lessons learned for external management based on audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics
  • At least 10 years of experience in clinical development and the pharmaceutical industry preferably with at least 3 years in Quality Assurance/ Compliance roles
  • Thorough knowledge of international GCP regulations including Food and Drug Administration (FDA)/ European Union (EU) GCP, ICH, pharmacovigilance, new drug regulations, other key Health Authority (HA) guidances, and current industry practice
  • Excellent negotiation and conflict resolution skills
  • Resolves issues with minimal supervision and understand when to escalate 6. Excellent problem solving and decision-making skills. Skilled at conflict resolution / negotiation
  • Excellent multi-disciplinary project management skills
  • Flexibility to react to changing priorities in a dynamic business environment 9. Considerable organization awareness (e.g. inter- relationship of departments, business priorities)

Senior Associate QA Resume Examples & Samples

  • Real-time Manufacturing Procedure (MP) and Electronic Batch Record (EBR) review and closure
  • Provide QA support for all GMP activities, including on-the-floor triage, act as QA contact on nonconformances, and CAPAs
  • Support routine GMP documentation review and approval, including revisions of MPs, EBRs, SOPs, and Logs/Logbooks to ensure compliance
  • Perform comprehensive quality review of deliverables in support of batch disposition, including verification of LIMS data
  • Escalation of significant quality issues to quality management in a timely manner
  • Bachelor’s degree and of 2 years of Quality and/or Manufacturing experience, OR
  • Associate’s degree and 6 years of Quality and/or Manufacturing experience, OR
  • High school diploma / GED and of 8 years of Quality and/or Manufacturing experience
  • Ability to interpret and apply cGMP and GDP
  • Quality Assurance or Manufacturing experience in the pharmaceutical or medical device industry
  • Good written and verbal communication

QA Senior Catalog Associate Resume Examples & Samples

  • Conduct regular audits of activities related to the functional area
  • Contribute to root cause analysis in escalation management
  • Create and update SOP/flow of processes
  • Identify process improvement opportunities (enhancements and pain points) at process/ function level
  • Demonstrate the ability to handle small-scale process-improvement projects
  • Leverage / demonstrate expertise in handling end-to-end processes and related tools; use them to identify operational issues
  • Train & mentor new hires on process tasks and provide feedback to the training team to customize training modules, if applicable
  • Responsible for achieving the predetermined targets for the new tasks on boarded
  • Perform audits and quality checks of tasks completed by junior associates and reports quality metrics
  • Measure catalog quality from process aspects and trigger the defects patterns for Systemic fix
  • Communicate the problem statement with data on operational processes for internal and external stakeholders
  • Create standard defined reports, i.e., weekly reports
  • Identify issues and proactively reports operational challenges
  • Managing CAPA for the quality issues
  • Strong written and oral communication skills in both English and Spanish or English and Italian
  • Bachelor’s degree or at least 3 years combination of education and work experience
  • Exceptional interpersonal skills, ability to build relationships and influence others without authority
  • Strong written and verbal communication skills, with an ability to communicate effectively at all levels of an organization
  • Strong organizational and project management skills, including prioritizing, scheduling, and time management
  • Proactive attitude, detail-oriented, and a team player
  • Proficient in Excel
  • Experience in 7 QC Tools
  • Experience in creating excel macros

Development Clinical QA Operations Associate Resume Examples & Samples

  • Operations meeting support for Global Head Onc Dev Clinical QA (ODQA) and Head Clinical Quality Operations (CQO). Lead operational meeting organization and planning for Global Heads
  • Responsible for meeting documentation, including agenda, minutes, actions and follow-up, for standing, off-site, and global team meetings, QRBs, and monthly activity reports
  • Administration for Oncology/Pharma/CQO QA finances and budget
  • Review internal costs on a monthly basis
  • Identify inaccuracies and variances, follow-up to assure adherence to budget targets
  • Track travel and other costs and report quarterly to Global Head ODQA and CQO
  • System management support for ODQA/Pharma/GCO QA
  • Support implementation of DevQA Quality Plan, track deliverables and assure owners meet implementation/deliverable deadlines
  • Support data gathering and compilation of information for Quality Review Boards
  • Generate reports from AQWA Audit and AQWA Quality Events
  • Support CAPA follow-up process and monitor planned and conducted audits in AQWA to ensure data quality and timely closure of open actions
  • Handling confidential personnel and regulatory documents
  • Inspection and audit readiness
  • Responsible for health authority inspection and audit operations, including back room support, document retrieval and logistics
  • Support inspection and audit readiness activities, including generation and compilation of regulatory relevant documents
  • Collect, store and maintain all auditable documentation as per Novartis internal standards
  • Communications and website administration
  • Draft departmental memos and email communications on behalf of Global Heads; send for approval and distribute
  • Maintenance of the Oncology/Pharma Dev CQA webpages and SharePoint sites. Regularly check sites for accuracy, update information, and compile new content as required
  • At least 5 years administrative experience, preferably in a pharmaceutical/scientific environment
  • Highly proficient in Microsoft Word, PowerPoint, Excel, Adobe Connect, Sharepoint, Concur, Ariba and Outlook
  • Strong understanding of Novartis Organizational policies and procedures; and able to work with international colleagues
  • Demonstrated history of providing executive level support and interaction with all levels of management
  • Capable to handle multiple tasks concurrently with tight time schedules by appropriate self-prioritization of work with minimal supervision
  • Ability to initiate quick follow-up actions and to perform duties with a great deal of latitude for independent judgment
  • Must be proactive, efficient, customer-focused and able to work under pressure with tight timelines
  • Strong attention to detail with good organization skills and ability to exercise independent judgment
  • Able to deal with high-level contacts and exposure to sensitive information/

QA Investigation Associate Resume Examples & Samples

  • Final review and quality evaluation of investigations of deviations from standard operating procedures, sterility test failures, out of specification and out of trend results
  • Review and evaluate investigations of product complaints
  • Evaluate and incorporate training programs to enhance root cause training and investigation writing
  • Review R&D Technical Transfer documents for completeness prior to acceptance for product/process validation at the manufacturing site

QA Operations Associate Resume Examples & Samples

  • To be responsible for the individual batch record review and release by supervising the activity of pre-contract review (SOW) and the review of manufacturing and QC test data
  • To support operations in inspecting equipment, releasing equipment’s, releasing incoming materials, reviewing data and generally any support task that Operations require to continue Production
  • To ensure, together with QMS Manager that procedures and processes are followed in line with Catalent Micron Technologies Ltd.’s Quality Manual
  • To ensure that the services provided meet all regulatory requirements and also client quality technical agreements
  • To support, assure and advice New Product Introduction into the facility in line with cGMP’s requirements
  • To safeguard the quality of materials and data handled or processed in accordance with regulatory and cGMPs requirements
  • Ensure all facilities, systems, equipment, operations and data etc. are all time validated in accordance with GMP standards
  • To conduct investigations relative to complaint, liaise with the customer, participate in the CAPA implementation
  • To conduct investigations relative to a deviation and OOS and identification of appropriate CAPAs
  • To assure trending and management of complaints, deviations, CAPAs and other metrics affecting product quality when required
  • To support completion of the internal audit

Associate, QA Systems Resume Examples & Samples

  • Responsible for the process of document control, including managing drafts, editing, approval, change control, distribution and archiving, of all controlled documents (e.g. Standard Operating Procedures (SOPs), Batch Production Records, Stability Protocols, Qualification Protocols, Specifications, Equipment Records, etc)
  • Edits Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and reports independently and accurately
  • Manages and distributes SOPs and other controlled documents
  • Assists with document retrieval during customer audits
  • Performs other related quality tasks as assigned, which may include data review
  • Associate’s Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum two years’ related experience

QA Senior Associate Resume Examples & Samples

  • Manage the risk management system, including:developing risk management tools; generate and providing training; generating metrics; leading continual improvement activities
  • Manage the data integrity system, including:assisting staff with performing data integrity assessments; providing training on using the assessment tools; leading continual improvement activities
  • Support quality systems such as change management, deviations, CAPA and training, as needed, including:processing records, sending notifications, collecting metrics, etc
  • Support product recall activates and participate in continual improvement activities
  • Represent Quality Assurance on cross-functional teams participating in various operational programs such as risk management activities and other continuous improvement activities
  • Write/revise quality procedures or other department operating procedures
  • Provide support for audits and inspections, as needed
  • Supervise and mentor entry-level associates
  • Bachelor's degree and 8+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry
  • Working knowledge of cGMP is required, including ability to understand and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
  • Able to integrate learning from industry conferences or guidance documents into company procedures
  • Excellent written and oral communication skills required
  • Able to organize information in a consistent and readily retrievable manner
  • Enthusiasm for the work and ability to proactively implement continual improvements desired
  • Strong team player that can also work independently to achieve objectives

QA Document Control Associate Resume Examples & Samples

  • Manage document requests from staff throughout the facility (laboratory, manufacturing, management, etc)
  • Assign, track and reconcile GMP documentation
  • Ensure documents meet company standards and regulatory requirements
  • Manage and maintain document archive program
  • Make recommendations to operating departments on procedural or documentation changes/improvements
  • Assist with the improvement of quality compliance by recognizing issues and bringing them to the attention of QA
  • Assist with maintenance of quality systems including deviations, quality investigations, environmental monitoring trending, quality control activities, etc
  • Minimum Associates degree in science with 3-4 years experience in GMP regulated environment
  • Preferred Bachelor’s degree in science with 1-2 years experience in a GMP regulated environment
  • Experience with ensuring compliance of documentation in a regulated environment
  • Experience with good documentation practices
  • Must have experience with Microsoft Word and the ability to utilize formatting, editing, styles, etc
  • Must have good communication skills and the ability to escalate issues to management when necessary

QA Batch Review Associate Resume Examples & Samples

  • Evaluates the impact of deviations and adverse events to product quality
  • Supports most quality functions and potential issues for assigned clients
  • Conducts cGMP audits including audit preparation, execution of the audit, the audit report, and follow up to any findings. Assists in the writing of detailed reports and analyzes quality data
  • Creates, revises, and reviews SOPs including compliance documentation initiation, revisions, and deletions. Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
  • Assists in the training of new employees and other technical personnel
  • Performs Line Clearances for cGMP processes
  • Creates cGMP labels, and reviews and reconciles cGMP label generation
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices

Senior Associate QA Resume Examples & Samples

  • Perform routine incoming QA disposition for incoming materials and cell banks
  • Provide quality oversight for supplier quality management (SQM) and contractor management which may include
  • 2-4 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry, biopharmaceutical production experience preferred
  • Should have good understanding of GMP pharmaceutical operations
  • Good communication skills (technical writing and verbal communication/presentation)
  • Interact effectively with variety of communication and working styles and ability to work well in teams
  • Ability to manage multiple simultaneous activities in a rapidly changing environment
  • Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to incoming quality and supplier quality management

QA Clearance Associate Resume Examples & Samples

  • Reviews completed Device History Records (DHR)/Master Batch Records (MBR) for completeness and accuracy prior to product release
  • Releases/clears products in electronic inventory system
  • Interacts with other departments to coordinate the completion of necessary corrections to the Device History Records and related documents
  • Performs other independent non-product clearance activities as assigned by the department manager (i.e., TrackWise activities, internal audits, Departmental Training Coordinator, and special projects)
  • University degree with two to five years industry experience. One to three years of QA/QC experience preferred
  • Familiarity with regulated manufacturing processes and life sciences required
  • Database and spreadsheet creation and maintenance; filing, organization, record keeping and planning skills; ability to manage multiple projects concurrently; time management skills

Associate Specialist, Food Safety & QA Resume Examples & Samples

  • Carry out basic and advanced microbiological testing and related activities including, but not limited to
  • 6 months to 1 year of experience in a microbiological laboratory setting required
  • Strong understanding of aseptic technique and advanced microbiological analysis including PCR
  • Proven ability to work independently with little to no supervision
  • Knowledge of Good Laboratory Practices (GLPs)
  • Laboratory safety experience
  • Computer literate (knowledge of Microsoft Word, Excel, Outlook)
  • Good interpersonal, communication, and organizational skills
  • Ability to work well independently and in a team based environment
  • Able to handle multiple tasks in a timely manner
  • Ability to be flexible with shifting priorities

QA Senior Associate Resume Examples & Samples

  • Assess employee performance via recorded call, monitored calls, e-mails or other documented forms of customer contact for ABC / RBC purposes
  • Measure process performance (gaps) identified in contacts
  • Assist with development of the call center training, QA process, and process improvement
  • Input and distribute grades to appropriate department for review
  • Interact with Work Leaders, Supervisors, and Managers
  • Experience in a Quality Assurance environment in a call center or electronic toll collection industry
  • Stable work record and job history
  • Minimum of two (2) years of customer service experience
  • Ability to handle multiple tasks at a time
  • Work with a high sense of urgency in a deadline driven environment
  • Effective and efficient working in a team environment

Associate QA Test Specialist Resume Examples & Samples

  • Assist with coordination activities for all test cycles, including: project initiation tasks, script edits, binder creation, setup, and status tracking
  • Organize documentation and archiving of test materials
  • Complete ad-hoc testing in supplement to application teams
  • Assist QA Team as needed, in an effort to advance knowledge

Associate Software QA Analyst Resume Examples & Samples

  • May create test plans from specifications
  • Executes test plans and test cases and compiles results
  • Assessing and managing strategic risks:ability to seize opportunities in a complex environment

Senior Associate, QA Systems Resume Examples & Samples

  • Maintains and enhances effectiveness of the Quality System by monitoring and managing the electronic systems use to track deviation, change control and training compliance
  • Accountable for the compliance of deviation and change control system
  • Writes, edits, and reviews procedures and job aids associated with electronic systems
  • Develops and maintains training items and curricula in the LMS
  • Manages the administration and compliance of change controls in TrackWise®
  • Serves as local TrackWise® and ComplianceWire® Subject Matter Expert performing administrative functions for both systems
  • Tracks/monitors training and provides timely, accurate information including metrics to management for actions needed to ensure compliance
  • Provides formal and informal training and guidance on use of the electronic systems for the QMS at Catalent
  • Maintains data integrity and ensure compliance with company SOP’s, specifications; as well as cGMP, ICH, FDA, EMA regulations or guidelines
  • Maintains and enhances effectiveness of the Quality System. Files and maintains controlled documents
  • Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 3 years’ of related experience
  • Associate’s Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum 4 years’ of related experience

Associate QA Resume Examples & Samples

  • Academic and HBO (higher education) in biochemistry, biology or a pharmaceutical degree, and depending on education, 5 to 7 years relevant working experience in a GMP environment
  • You have a great sense for quality and excellent analytical abilities
  • You can make well motivated decisions on your own
  • You have an excellent proficiency in English both in word and in writing
  • You have strong oral and written communication skills
  • Experience in methods such as Process Excellence, Co Think and Kepner-Tregoe is recommended.1700174307W

Associate QA Compliance Specialist Resume Examples & Samples

  • Customer Complaints
  • Quality Risk Management
  • Change control documents
  • Maintaining electronic systems used for Change Control and Deviation Management
  • Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements
  • Provision of monitoring and trending metrics associated with site quality systems
  • Participates in regulatory and customer audits
  • Participates in quality risk assessments
  • Requires BSc/BEng in scientific discipline or related field. 1-3 years of relevant work experience in pharmaceutical or related industry desirable