QUALITY ASSURANCE ANALYST LEVEL II

Position Summary:

Professional Quality Assurance Analyst II will possess strong project leadership skills. In support of the clinical product software, the QA Analyst II will work to ensure that the product meets specified requirements, working as an essential member on QA team. The QA Analyst II will write and update test cases. QA Analyst II will work as a member of a cross functional team including clinical staff, product analysts, software engineers, and QA analysts. Therefore, effective communication, collaboration, and team work is essential for success. The QA Analyst II will execute the quality assurance and software change disciplines as directed by the QA Team Lead.

DIRECT REPORT TO: QA Team Lead
INDIRECT REPORT TO: QA Manager and Director of QMS

PERSONAL QUALITIES:
Professional; adaptability; possess strong teamwork building capabilities; excellent time management skills; strong communication skills to articulate complex technical issues; self-starter with ability to lead projects from design to delivery through all quality phases of development lifecycle. Must be able to work in a project oriented team environment.

POSITION RESPONSIBILITIES
As an example of some of the major responsibilities of the position:

• Produces well-structured, documented and maintainable test cases and/or scripts for manual testing that support the verification test cycle in accordance with current SDLC processes.
• Executes test cases and/or scripts and documents results in Quality Center accordance with defined test plans and procedures.
• Creates clearly documented bug reports for anomalies found during test procedures.
• Responsible for ensuring the software complies with the requirements set forth in the FDA guideline 21 CFR Part 11.
• Produces clear concise documentation of the results of execution of test cases in conjunction with the execution of test phases during product qualification, including Migration Release Summaries, and Risk assessments.
• Leads medium to high level projects
• Adheres to established test methodologies for validation and verification of product releases.
• Works to perform tasks according to needs and schedules as driven by business and customer needs.
• Estimates work tasks to ensure delivery by agreed timescales
• Performs tasks at the highest level of integrity.
• Develop a detailed understanding of how and why clients use the application
• Help ensure overall product quality
• Effectively collaborate and communicate with others
• Become an expert her/his product features/functionality
• Ensure that related test plans are run for all changes made to the system.
• Assist in the identification and resolution of program, system and subsystem deficiencies.
• Enter into, maintain and close software related issues in Quality Center.
• Ability to identify process improvements.
• Assemble client specific software validation packages.

REQUIREMENTS:

KNOWLEDGE/SKILLS/ABILITIES

• Excellent problem solving skills.
• Good interpersonal, organizational, communication, presentation and reporting skills are required.
• Will be knowledgeable of software quality assurance and change control concepts, practices and procedures and have experience and judgment in planning, implementing and accomplishing related goals. Must be familiar with structured models and methodologies like: Six Sigma, CMMI, ISO9001, GAMP5, GCP, GMP, IEEE, etc
• Have technical experience to include but not limited to .Net framework, Microsoft SQL Server Database, Quality Center, Test Director, QTP
• Should be familiar with Quality Assurance in FDA regulated industry.
• Experience working within an SDLC process

MINIMUM PHYSICAL/VISUAL/HEARING ABILITIES

• Ability to perform light lifting in the handling of work materials and equipment.
• Requires visual skills necessary for reviewing a considerable amount of written materials for the accurate maintenance of information and records.

EDUCATION/TRAINING /EXPERIENCE

• Clinical software experience strongly preferred
• Bachelors degree in Engineering, Computer Science or Technology discipline is preferred
• Ideally, will have minimum of 4-7 years commercial software testing experience within the Clinical industries.
• Technical 4+ degree preferred. Equivalent combination of education, training and experience will be considered.
• One of more certifications strongly desired: Six Sigma, Belt Certified, SQA, SCE, CQE, Certified Clinical Data Manager, Certified Clinical Project Manager, Certified Quality Assurance Specialist
• Familiarity with Bio Pharmaceutical experience preferred
• Clinical trial experience is a plus.