QA Specialist Job Description
QA specialist
provides internal and external customers with knowledge regarding Quality Assurance practices while following Good Manufacturing Practice (GMP) guidelines.
QA Specialist Duties & Responsibilities
To write an effective QA specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included QA specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Supports & GMP conducts GMP/ICH Q7a training as required
Maintain a database of the technical specifications, legal status, game engine and sdk’s of each build version
Provide access and maintain the technical and specification guides for developers, communicating and distributing these as they are updated
Maintain and distribute the up to date provisioning profiles
Provide advise and guidance to developers on technical and specification issues around the supply of builds and assets
Liaise with external suppliers maintaining an accurate record of quote and invoices
Develop and execute test plans, test cases and procedures, and test scripts, to include user acceptance testing
Review and approve cGMP records (e.g., electronic batch record, change controls, NC, CAPAs, design qualifications, SOP, ) ensuring compliance with appropriate documentation
Monitor the operations at the Contract Manufacturer
Assist with pulling and analyzing reporting to uncover potential errors/issues before they become revenue impacting
QA Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QA Specialist
List any licenses or certifications required by the position: ISTQB, ISO, ASQ, FSSC22000, GMP, ASNT, API, GIAC, CISSP, CISCO
Education for QA Specialist
Typically a job would require a certain level of education.
Employers hiring for the QA specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Science, Engineering, Education, Chemistry, Technical, Biology, Manufacturing, Computer Science, Pharmacy, Business
Skills for QA Specialist
Desired skills for QA specialist include:
SDLC
GMP
Current Good Manufacturing Practices
Performance and security vulnerability testing
Testing concepts
Microsoft Office applications
STLC
Excel
FDA / EMEA standards and quality systems
CGMPs
Desired experience for QA specialist includes:
Occasional use of Final Cut Pro to make edits and additions to video assets
A minimum of a B.S
Conducts internal audits and reviews/analyzes data and documentation for errors
Must be able to use multiple computer applications
Must be able to work independently on repetitive tasks and complete tasks within specific timelines
Ability to document, and report trends or potential training issues based on work reviewed
QA Specialist Examples
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QA Specialist Job Description
Job Description Example
Our company is growing rapidly and is looking for a QA specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for QA specialist
- Delivery and documentation of training which may include GMP modules, SOP’s, Gowning, General micro related training
- Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment)
- Adheres to and supports the company safety policy and safety programmers
- Engages in Site Credo initiatives
- Collaborating with relevant stakeholders in site Glostrup and Carpentaria concerning execution of daily tasks
- Secure and maintain relevant knowledge of Agile and BMS systems
- Keeping updated with relevant regulations and scientific knowledge within the area in Agilent quality system
- Improving knowledge and competencies by internal on-the-job training
- Working in accordance with quality management, ISO 13485 and 21CFR820 (FDA)
- Provide testing support for all applications with minimal direction and supervision
Qualifications for QA specialist
- Familiarity with ad-serving systems (FreeWheel, DFP-P)
- Minimum of 3-5 years' experience in QA/Compliance in pharmaceuticals or related industry
- Thorough knowledge of either EU GMPs and/or Medical Device Directives
- Computer literate essential including working knowledge of MRP system
- Expertise in specific compliance disciplines (non-regulated, GLP, GCP, PV or computerized systems) preferred
- Overnight travel, nationally and internationally, up to 40% .R&D
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QA Specialist Job Description
Job Description Example
Our innovative and growing company is hiring for a QA specialist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for QA specialist
- Define and track quality assurance metrics such as open defect counts, production defects, etc
- Supporting the establishment, periodic review and improvement of the DCIT Quality Management System (QMS)
- Executing audits in alignment with the audit program schedule, ensuring continued governance and improvement of the DCIT QMS
- Initial point of contact for Quality related issues identified on allocated programs/projects, ensuring escalation to the HoQ or delegate as required
- Identifying and capturing robust internal and external Customer requirements through the use of tools such as Quality Function Deployment (QFD)
- Increasing Quality awareness and building key working relationships with stakeholders
- Monitoring, analyzing and reporting of Key Performance Indicators (KPI) identified as part of the QMS
- Implementing preventive measures to reduce the severity and likelihood of product or process failure using tools such as FMEA, risk planning and peer reviews amongst others
- Generating Quality management plans in accordance with ISO 10005 guidelines
- Implementing the Corrective Action process and procedures using established Root Cause Analysis (RCA), 8D and 5-Whys tools
Qualifications for QA specialist
- A technical understanding of testing methodologies, tools, frameworks, and best practices
- Experience with a variety of testing and automation tools
- Demonstrate depth and breadth of knowledge when it comes to setting up and executing Test Cases on complex test beds
- Be able to analyze multi-dimensional problems by gathering relevant info and working with others (designers) to pinpoint root cause
- Expertise in developing test strategies and plans and producing test cases based on requirements documents
- Testing of application reliability, availability, accessibility, usability, and maintainability/support
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QA Specialist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of QA specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for QA specialist
- Manage document control process through MasterControl
- Experience with Test Driven Development and CICD practices
- Define and advocate required standards of sterility assurance for aseptic manufacturing areas
- Feedback microbiological data to the manufacturing floor to help improve awareness and to drive improvement in aseptic practices
- Ownership of, or providing support for, Continuous Improvement activities, Regulatory Compliance and Technical projects
- To fully utilise the environmental monitoring data in order to trend the sterile manufacturing performance and to identify key trigger points
- Undertake aseptic audits across the value stream
- Support process simulation/media fill activities where required
- Identify data anomalies and investigate their cause and effect
- Participate in the review of requirements
Qualifications for QA specialist
- Minimum 5-8 years work experience on food quality and safety area
- Experiences on customer complaint handling
- Familiar with ISO 9001, HACCP, ISO22000, FSSC 22000 quality &food safety system
- Quality and food safety audit skill
- Special training in QA and understanding of food hygiene and food safety systems
- Familiar about the main food safety, quality law, regulation and standard system of SEA
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QA Specialist Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of QA specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QA specialist
- Maintain relevant GxP training compliance requirements and support delivery of training courses and relevant learning material
- Approve all laboratory data generated by the BioCTL ensuring that these data have been generated using the correct procedures and systems
- Perform department’s self-inspection (L1) audits, maintaining associated schedules and documentation
- Assist in the preparation for and participation in regulatory agency inspections, corporate, customer and monitoring L2 audits including audit readiness assessments
- Collection, sorting and auditing of Anesthesia Data Forms (ADFs)
- Scanning paper forms to convert data into electronic format using Readsoft application
- Manual entry of clinical data into the Spectrum database
- Utilize mechanisms to update facilities on data, clinical outcomes and other relevant information to support clinical quality patient care
- Reporting of information including but not limited to CRNA data, Physician data, and various established clinical benchmarks including Nausea & Vomiting, ASA Physical Status, Critical Events, Time of patient stay, Abx/Incision time difference, & PACU reports including ready/discharge times, reasons for delay in discharge, & Nausea & Vomiting
- Troubleshoot Database and work with IT on maintenance/repair concerns (Spectrum Access-based database
Qualifications for QA specialist
- At least 1-3 yrs of experience writing test automation scripts (Java, C#, Ruby)
- Proficient in writing end-to-end user acceptance test cases and scenarios
- Third level Scientific degree and at least 3 years QA/Validation experience.Quality Assurance
- Ability to facilitate and negotiate between departments/divisions
- Ability to regularly exercises discretion and independent judgment the in performance of his/her job duties
- JBehave
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QA Specialist Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of QA specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for QA specialist
- Supports implementation activities by defining business requirements for internal business owners that will comply with regulatory and contractual obligations
- Collaborates with clinical operations, utilization management, and other functional departments to support regulatory or contractual obligations
- Develop and maintain positive relationships with key health plan operations
- Development of operational reporting, including building or refining reporting business rules as needed, and validation of regulatory reports for our delegated arrangements
- Provide support for regulatory or contractual submissions, such as Organizational Determination reports (ODAG) reporting
- Develop/maintain operational monitoring tools, including Regulatory Reporting Grid and Health Plan Reporting Calendar
- Act as operational lead for regulatory audits, including health plan, CMS, or state audits
- Prepare internal reports and presentations in support of Joint Operation Committee meetings and other related meetings
- Write and conduct validations (IQ/OQ/PQ) for manufacturing processess and equipment
- Review Device History Records (DHR) and Master Batch Records (MBR) and supporting documents
Qualifications for QA specialist
- Experience in testing game builds in a QA environment
- At least 1-3 yrs of experience in software testing utilizing automated testing tools (Selenium, Ranorex, Loadrunner)
- At least 2 years’ experience functional end-to-end testing, system testing, batch processing, user acceptance testing, and regression
- At least 2 years’ experience with project management methodologies, including Agile methodologies and supporting techniques
- At least 2 years’ automation scripting experience working on automation frameworks
- 3-5 years of experience in QA specialist / CSV role