Quality Assurance Analyst I - PDQA (Bangalore, India)

POSITION SUMMARY

Staff-level position responsible for implementing Quality Assurance Software Change Control policies and programs. In support of the clinical product software, the Quality Assurance Analyst I will work to ensure that the product meets specified requirements, working as an essential member of the QA team. The QA Analyst I will write and update test cases. The QA Analyst I will work as a member of a cross-functional team including clinical staff, product analysts, software engineers, and QA analysts, so effective communication, collaboration, and teamwork are essential for success. The QA Analyst I will execute the quality assurance and software change disciplines as directed by the QA Team Manager or Director of QA.

PERSONAL QUALITIES

• Professional
• Adaptable
• Strong teamwork building capabilities
• Excellent time management skills
• Strong communication skills to articulate complex technical issues
• Self-starter
• Must be able to work in project-oriented team environment.

RESPONSIBILITIES

• 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.
• 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.
• Helps ensure overall product quality.
• Effectively collaborates and communicates with others.
• Becomes an expert of their product features/functionality.
• Ensures that related test plans are run for all changes made to the system.
• Assists in the identification and resolution of program, system and subsystem deficiencies.
• Enters into, maintains and closes software-related issues in Quality Center.

SKILLS NEEDED

• Good interpersonal, organizational, communication, presentation and reporting skills are required.
• 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.

QUALIFICATIONS NEEDED

• Technical Bachelor’s degree preferred. Equivalent combination of education, training and experience will be considered.
• 0 – 2 years of work experience in the software quality assurance field.
• Experience working within an SDLC process.
• Clinical software experience strongly preferred.
• One or more certifications strongly desired: Certified Quality Assurance Specialist.
• Will be knowledgeable of software quality assurance and change control concepts, practices and procedures and have experience and judgement in planning, implementing and accomplishing related goals. Must be familiar with structured models and methodologies.
• Have technical experience to include but not limited to Microsoft SQL Server Database and Quality Center.
• Should be familiar with Quality Assurance in FDA regulated industry.
• Familiarity with Bio Pharmaceutical experience preferred.
• Clinical trial experience is a plus.
• Knowledge on Automation is a plus.

The Department Head has the discretion to hire personnel with a combination of experience and education which may vary from the above listed qualifications.

Please submit resume and cover letter to: India-OpenReqs@AnjuSoftware.com