Programming Language: Python, Shell script, and SQL; - Operating systems: Windows, UNIX or Linux; - Database: Oracel, My SQL, and Post Gre SQL; - Hypervisor Platforms: VMware ESX, KVM and Hyper-V; - Cloud Applications: AWS, Azure and Google Cloud Platform; - Network protocols and technologies: SNMP, WMI, - Testing Tools: Py Charm, Postman, Selenium, Mantis, Testlink.
Salary Range: $226,325 to $271,325 per year Email resume to, must reference job title and code: Sr. Manager, Software Development QA [231201TS]. [#LI-DNI]
1 Visa : Only US citizens and Greencard holders JOB DESCRIPTION: our vision is creating future cell therapy miracles together.
We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products.
We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality
Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs.
He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. ESSENTIAL FUNCTIONS AND RESPONSIBILITES: Schedules batch record process for all floor associates in accordance with kitting schedule. Facilitates internal training on quality assurance requirements, processes, and procedures. Provides
technical expertise to the client services team on tech transfer activities.
Provides supportive documents to investigators and/or compliance team. Conducts final verification of batch records prior to archiving; sends records to document control; Review of executed APS reports/ batch records. Draft SOPs, WIs, and Forms for revision. Supports QA teams with continuous improvements initiatives to enforce quality culture. Initiate change control as required. Assist gathering information for internal and external (e. g. c GMP, client, regulatory agencies) audits. Support walk thru in preparation for internal and external (e. g. c GMP, client, regulatory agencies) audits.
Other duties as assigned. Supervisory Responsibilities Indirectly supervises QA Associates I and II within the Quality Assurance department Team lead for 2-3 QA Associates 1 & IIQUALIFICATIONS: Bachelor of Science in biological sciences or other relevant field of study Minimum 5 years experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics. Working knowledge and technical understanding of aseptic manufacture of biologicinteractionperience in both clinical and commercial manufacturing is preferred. Experience in authoring, reviewing, and /or approving c GMP/c GTP related documents (validation/qualification reports, SOPS.
Etc. Experience in organizing teams for effective and timely completion of projects. Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc. Experience participating in or hosting health authority inspections and/or client audits. ADDITIONAL QUALIFICATIONS: Relevant computer skills (Microsoft Office, Outlook)Detail-oriented and organized Analytical and problem-solving skills Good written and oral communication skills Ability to multi-task and be adaptable Flexible and able to adapt to company growth and evolving responsibilities Ability to work independently and with a team Strong Project Management and organization skills.
Minimum Required Training to Be Completed within the first 90 Days of hire GXP training SOP & WI training Safety Training Working Environment Must have the ability to work in a team-oriented environment and with clients Must be able to work during the weekend, holidays and as required by the company May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc.
Understanding of quality system applications Must be able to handle the standard/moderate noise of the manufacturing facility. Physical Requirements Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear The employee is frequently required to lift and/or move up to 30 pounds. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.
Duties, responsibilities, and activities may change at any time with or without notice.
with advanced programming skills? who can create automation testing tools and frameworks to assist the manual testing process. Working? as an individual contributor you will analyze product development design, articulate expected testing? approaches, build and maintain test scripts, execute functional and regression tests using both manual?
and automated test suites, and collaborate with other functional teams on aspects of the feature or? sub-system. Assist in driving quality and excellence through a detailed approach to automation. Responsibility of a Software Developer Engineer in Test (SDET)? Being a part of an Agile team, reviewing and contributing to user stories to identify acceptance
criteria, while building test scripts (manual and automated) to validate criteria. Serve as the voice of the customer in evaluating the quality of our software, which entails offering input into the product design and process to improve our overall delivery.
Debugging software products using systematic test design to develop, apply, and maintain quality standards for company products. Developing, modifying, and executing software test plans, automate scripts and programs for testing. Installing, configuring and maintaining automated testing framework. Implementing, executing, and debugging automated UI and API level test scripts using various technologies and tools. Conducting all phases
of software testing including test planning, functional, integration and?
regression testing. Contributing along with fellow QA automation engineers on test automation best practices. Collaborating with product owners, and software engineers to understand requirements and business use cases. Ensuring that validated deliverables meet functional and design specifications and requirements. Setting up and tearing down environments for internal and external testing as needed including the creation of common use case configurations for internal testing and customer integration. Ability to set up test framework environments and test beds.
Palo Alto, CA location to work in product, cross functional or testing team with special focus to quality assurance and test related tasks within the product creation process. Expectations and Tasks: Define quality and test strategies for products respecting defined process and product standards.
Analyze, define, implement and execute quality and test related activities according to this quality and test strategy. Create a detailed test design including test system landscape definition and product standards, prepares tests (customizing and master data), authors and executes manual and/or automated tests. Analyze test results (issues) and takes appropriate follow-up actions. Subject matter
expert for teams in terms of quality assurance and test related processes, methods and tools. Initiate process or tool improvements. Education and Qualifications/Skills and Competencies: Bachelor's degree or foreign equivalent in Computer Science, Engineering, Mathematics or a related field of study and 6 years of progressive post-baccalaureate experience in the job offered or a related occupation.
The Company will also accept a Master’s degree or foreign equivalent in Computer Science, Engineering, Mathematics or a related field of study and 4 years of experience in the job offered or a related occupation. Work Experience: Experience must involve 4 years in the following: Test landscape
and the automation tools used in testing automation scripts, including Selenium, JUnit, and JMeter and REST API testing.
Experience to include each of the following : Programming in Object Oriented Programming languages; Programming in Java; Database technology, including SQL; Orchestration tools, such as Jenkins; and Computer science algorithms and data structures. Travel: N/A. Telecommuting permitted. This position is eligible for the Employee Referral Program subject to the eligibility criteria outlined in the SAP Internal Employee Referral Policy. Internal use only: reference code lhrs4262 SAP: SAIL Compensation Range Transparency: The annual base salary for this position is $226,325.
Please reference this link for a summary of SAP benefits and eligibility requirements: SAP North America Benefits. We build breakthroughs together SAP innovations help more than 400,000 customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has evolved to become a market leader in end-to-end business application software and related services for database, analytics, intelligent technologies, and experience management. As a cloud company with 200 million users and more than 100,000 employees worldwide, we are purpose-driven and future-focused, with a highly collaborative team ethic and commitment to personal development.
Whether connecting global industries, people, or platforms, we help ensure every challenge gets the solution it deserves. At SAP, we build breakthroughs, together. We win with inclusion SAP’s culture of inclusion, focus on health and well-being, and flexible working models help ensure that everyone – regardless of background – feels included and can run at their best. At SAP, we believe we are made stronger by the unique capabilities and qualities that each person brings to our company, and we invest in our employees to inspire confidence and help everyone realize their full potential.
We ultimately believe in unleashing all talent and creating a better and more equitable world. SAP is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to the values of Equal Employment Opportunity and provide accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with SAP and are in need of accommodation or special assistance to navigate our website or to complete your application, please send an e-mail with your request to Recruiting Operations Team: xyz X@.
EOE AA M/F/Vet/Disability: Qualified applicants will receive consideration for employment without regard to their age, race, religion, national origin, ethnicity, age, gender (including pregnancy, childbirth, et al), interactionual orientation, gender identity or expression, protected veteran status, or disability. Requisition ID: 384952 Work Area: Software-Design and Development Expected Travel: 0 - 10% Career Status: Professional Employment Type: Regular Full Time Additional Locations: #LI-Hybrid