Specialist QA Job Description
Specialist QA Duties & Responsibilities
To write an effective specialist QA job description, begin by listing detailed duties, responsibilities and expectations. We have included specialist QA job description templates that you can modify and use.
Sample responsibilities for this position include:
Specialist QA Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Specialist QA
List any licenses or certifications required by the position: ISTQB, ISO, ASQ, FSSC22000, GMP, ASNT, API, GIAC, CISSP, CISCO
Education for Specialist QA
Typically a job would require a certain level of education.
Employers hiring for the specialist QA 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 Specialist QA
Desired skills for specialist QA include:
Desired experience for specialist QA includes:
Specialist QA Examples
Specialist QA Job Description
- Troubleshoot day to day issues to ensure minimum downtime as a result of microbiological or environmental issues and lead Root Cause investigations in to Microbiological excursions
- Support/ consult with the necessary functions to ensure new policies/processes are successfully scoped and rolled out with measurable results against key metrics
- Participates/leads in customer calibration programs to identify customer needs and expectations
- Prepares appropriate documentation and executes release of acceptable product lots and vendor materials
- Reviews completed manufacturing, filling, and labelling records, and analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Audits production and other departments for quality system effectiveness
- Provide input to estimating models and refine factors as necessary
- Involve in supplier audit
- Suppot for inspection/testing plan/ /sampling plan/environment monitor plan setting and ensure implementation
- Carries out administration on SAP MRP
- Establishes effective partnerships with other individuals and departments so that quality systems and compliance activities are well understood and executed to a high standard
- Sound technical knowledge of Apple and Android device specifications
- Experience of deploying assets and builds to Apple and Android stores
- Excel, Word and PowerPoint efficiently for organizing information so that it can be presented it in a clear, concise manner
- Occasional use of Photoshop to make adjustments and additions to screen images
- Position is back-up to administrative assistant so must be available on a rotating schedule
Specialist QA Job Description
- Through requirements and design reviews, gain understanding of the functional and non-functional testing requirements, for applications being developed and ongoing maintenance of the software
- Participate in entire testing lifecycle, including test planning, test preparation, test execution and defect management
- Formulate and execute test cases to determine if the application under test is ready for production
- Conduct functional, system and regression testing activities for all business applications in support of corporate initiatives and development projects
- Facilitate the learning of non-exempt associates performing similar role and personnel at external suppliers through leading calibrations, writing reports
- Work with business points of contact for businesses being reviewed to resolve call capture issues
- Recommend, architect and implement appropriate automation frameworks to test multiple applications, architectures and technology
- Develop and execute test plans with the assistance of Programming staff and Business Analysts
- Identify test requirements from specifications, mapping test case requirements and designing test coverage plan
- Validate that deliverables meet functional and design specifications and requirements
- Internet savvy with a deep-seated passion for Video
- Understanding and experience with technical troubleshooting
- Fast learner who can grasp new material quickly
- Ability to effectively prioritize projects
- Advanced knowledge of the systematic approach for creating and executing test cases based on business-approved functional requirements
- A University or post-Graduate degree in Information Technology, Computer Science, Computer Engineering, or related field is preferable
Specialist QA Job Description
- Participate in root cause analysis for deviations, customer and service complaints as QA representative
- Ownership of quality systems, deviations, change controls
- Support QA compliance by providing metrics and report program trends on a periodic basis
- Analysis of incoming QA forms, review for accuracy & compliancy
- Create and Distribute reports to Facility Chairs, QA Cmte, routinely per scheduled expectations (monthly, quarterly and annual basis) requested ad hoc reports that may arise from staff or partnered facilities
- Training & cross-training of site personnel regarding the QA program, processes and expectations through on-site visits and phone/email communications
- Analyze trends and monthly usage of QA forms to efficiently manage source document inventory by facility
- On-Site visits to train personnel (as noted above) on QA Program
- Working with various facility departments and physicians at sites, including PACU, OB, & Anesthesia prepare/schedule/attend monthly AANC QA Committee
- Periodic reporting of factual Quality activity status to the HoQ or delegate for each Centre / Section or allocated programs/projects
- Proficient in database technology testing
- Ability to communicate both written and orally to all levels of management and across various cultural backgrounds· Previous experience in creation, implementation and maintenance of Customer Service Quality monitoring programs with proven qualitative results
- Strong Excel, Word, HTML or other technical skills are advantageous
- Superior judgments, diplomacy and tact
- Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug product manufacturing
- Degree in food Sciences or relevant work experiences (quality management, quality assurance, customer complaint or regulatory affairs)
Specialist QA Job Description
- Create detailed bug reports that allow Development to easily understand and correct the issue
- Work with Development to troubleshoot issues
- Provide project status to Project Manager
- Execute simple database queries
- Execute and interpret service calls
- Required to perform tracking and trending of the batch review process, CSP batch review data Incoming Quality Control data
- Supports Qualification Process for designated CSPs
- Provide administrative support to maintain required certifications and/or accreditations
- Due to the size of the site employees are required to flex into positions and activities outside their normally assigned duties as workload requires and as trained
- Reviewing of production documentation and assisting with batch release procedures • Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operations • Supporting the ongoing deviation / corrective action program • Liaising with other departments to allow closure of corrective actions • Participating in audits, together with follow up
- Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
- Adaptable and flexible, willing to work shift as needed
- Previous experience in Customer Service area with a background in a Quality Assurance role in a contact centre environment is preferred
- 3-5 years as a RN in Acute Care setting
- One year application testing and or equivalent application knowledge
- Basic understanding of test methodologies and testing processes
Specialist QA Job Description
- Review, revision and/or development of associated QA Program implementing procedures
- Participation in QA Audits and Surveillances
- Assist in the development of related QA program training
- Provide support in review and approval of deviation or laboratory investigations
- In collaboration with clinical leadership, development of new forms and redesign of existing forms
- Train/cross-train department personnel and adopt new processes and practices with MedSuite, Data Warehouse, Spectrum, Quantum and using existing databases in new ways
- Perform functional testing of the email (clicking links, confirming tracking data, ) to confirm accuracy
- Conduct audits, track progress, and trend results
- Monitors the Company’s internal operations to ensure compliance with regulatory and contractual obligations, defines and produces reporting to escalate risks and makes recommendations which will improve operational execution against requirements
- Participate in the definition and development of operational dashboards or scorecards to monitor compliance with contract requirements & support the development of improvement strategies, as needed
- Ability to aseptically gown
- 2 years directly applicable experience in the industry or equivalent combination of education and experience
- Proficient in the use of software (e.g., word processing, spreadsheets, database software ) is preferred
- Occasional bending, grasping, stooping, kneeling, crouching
- Technical) University or academic degree in Chemistry, Biology, Pharmacy or equivalent
- Educational Attainment Requirement