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Job Req ID: 27816 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing company among the Silicon Valley Top 50 technology firms. Our unprecedented global expansion has provided us with the opportunity to offer a large number of new positions to the technology community. We seek talented, passionate, and committed engineers, technologists, and business leaders to join us. Job Summary: Supermicro is seeking a talented Software QA Engineer with great attention to detail and strong problem-solving ability to join our software team. You will be responsible for examining all aspects of the products/applications, performing tests. If you are a forward-thinking engineer who can bring software quality improvement ideas and new strategies to lead the company forward, we would love to talk to you. Essential Duties and Responsibilities: Execute software automation. Perform IPMI, Redfish, BIOS, and software tools validation. Perform software user interface, functional, and stress testing. Provide feedback to the design team to improve product quality. Utilize analytical skills to validate and verify software/system issues. Create comprehensive test plans, procedures, and evaluation reports. Perform ad-hoc testing on Gold SKU and OEM systems. Participate in issue review sessions with cross-functional teams including PMs, FAEs, service teams, and customers. Ensure continuous testing coverage for top-priority projects through global team collaboration. Enforce software quality control standards. Qualifications: Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, Information Systems, or a related field. 5-7+ years of software quality assurance experience is preferred. Familiarity with SQA requirements and methodologies. Ability to adapt quickly and excel in a fast-paced environment. Creative thinker with a strong passion for quality. Experience with shell scripting and Python is a plus. Experience or familiarity with networking, switch validation, or related test environments is a strong plus. Ability to adapt quickly and work effectively in a fast-paced and dynamic environment. Excellent communication, documentation, and collaboration skills. Salary Range $100,000 - $135,000 The salary offered will depend on several factors, including your location, level, education, training, specific skills, years of experience, and comparison to other employees already in this role. In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation, such as participation in bonus and equity award programs. EEO Statement Supermicro is an Equal Opportunity Employer and embraces diversity in our employee population. It is the policy of Supermicro to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status or special disabled veteran, marital status, pregnancy, genetic information, or any other legally protected status. Job Segment: Cloud, Testing, Quality Assurance, QA Engineer, Embedded, Technology, Engineering

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. About the Job At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: Early Phase Quality Assurance is accountable for GMP Quality dedicated to the PR&D Early Phase Team. This position is responsible for providing technical leadership to the Early Phase Quality Unit and as well as providing day to day Quality oversight to the Early Phase teams and external partners in support of executing the portfolio of both early phase development assets within PR&D, SMDD and BRD. Key Objectives/Deliverables: Support delivery of early phase Pre-Commercialization Information and Materials within the Early Phase portfolio (typically through Phase II); ensuring quality expectations/requirements are consistently met. Ensure appropriate execution of the Early Phase Quality System to sustain compliance with regulatory requirements and good manufacturing practices Review and approve manufacturing documentation Disposition API, in-process materials, dosage forms and finished drug product to be used in Clinical Trials including management and review of GMP documentation, analytical results and regulatory commitments. Coordinate deviation and complaint investigations, as needed Review and approve deviations, change documents, and specifications for Early Phase materials Provide QA input to CM&C Development Plans as part of Early Phase deliverables. Ensure contract manufacturers and packagers, testing laboratories, vendors, and suppliers are qualified to assure compliance and integrity of the supply chain and oversee partner activities within a manner that optimizes compliance as well as efficiency. Collaborate with internal business and quality partners (SMDD, BR&D, PD, ELECTS) to ensure appropriate Lilly oversight of Early Phase activities at external partners Maintain and execute a Quality System aligned with LQS, GQS, and PR&D QS commensurate with Early Phase scope and phase of development. Provide on-site support at partners/CMO's for manufacturing, packaging and labeling activities of investigational medicinal products, and materials used to produce IMPs as necessary. Provide on-site support for internal manufacturing, packaging, labeling and distribution activities of investigational medicinal products, and materials used to produce IMPs as necessary. Identify opportunities for, and participate in, continuous improvement Ensure inspection readiness through site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems and provide support for internal and regulatory site inspections Influence PR&D QA management via identification and/or implementation of process improvement opportunities for external party governance within PR&D Early Phase. Actively monitor changes to global compliance environment, and industry developments, assess impact/compliance of Early Phase Quality system and quality strategy, and implement necessary changes. Mentor, coach and develop Early Phase QA Team Members. Minimum Requirements: Demonstrated relevant experience in global clinical trial cGMP regulations Breadth of technical and quality knowledge including API, drug product manufacturing, clinical trial packaging, analytical laboratories. Demonstrated expertise of cGMP and Quality Systems with a minimum of 5 years internal Lilly and external experience in any of QA, QC, Manufacturing MS&T, or Regulatory Ability to interpret/apply phase-appropriate GMP standards Proficiency with applicable computer systems. Demonstrated strong oral and written communication skills. Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills. Demonstrated attention to detail. Additional Preferences: Proven ability to work independently or as part of a team to resolve an issue. Previous experience in QA, QC, Operations, TS/MS, Engineering, or Regulatory is desirable. Knowledge of PR&D Quality Systems and/or CT Operations is preferred Experience in cGMP Auditing Education Requirements: Bachelor's degree in Science-related field or Engineering, or equivalent years of experience. Other Information: Travel US and OUS (including India and China) is required (15-25%) for collaboration partner oversight, training, conferences, etc. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Industry/Sector Not Applicable Specialism Managed Services Management Level Manager Job Description & Summary At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice, and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively. As a risk management generalist at PwC, you will provide advisory and practical support to teams across a wide range of specialist risk and compliance areas. Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and values in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: Analyse and identify the linkages and interactions between the component parts of an entire system. Take ownership of projects, ensuring their successful planning, budgeting, execution, and completion. Partner with team leadership to ensure collective ownership of quality, timelines, and deliverables. Develop skills outside your comfort zone, and encourage others to do the same. Effectively mentor others. Use the review of work as an opportunity to deepen the expertise of team members. Address conflicts or issues, engaging in difficult conversations with clients, team members and other stakeholders, escalating where appropriate. Uphold and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements. Minimum Degree Required Bachelor's Degree Minimum Year(s) of Experience 5 year(s) Demonstrates extensive knowledge and/or a proven record of success in the following areas: Quickly and agilely learn client HCP and HCO engagement processes and ways of working, analyzing for opportunities to optimize, develop, update, and govern team playbooks, SOPs, and process documentation to ensure operational consistency and compliance; Develop and maintain training plans for both new and existing team members; Designing and delivering training curricula for new hires and ongoing development for existing team members; Keeping training materials current with process changes, client requirements, and industry/regulatory updates; Managing and delivering structured onboarding programs for new hires to ensure smooth integration and readiness; Providing coaching and skills development opportunities to build functional expertise across the team; Partnering with leadership to identify training gaps and address them proactively; Designing and executing quality monitoring frameworks to evaluate managed services team delivery accuracy, compliance, and timeliness of deliverables; Conducting regular quality reviews of outputs (e.g., tiering assessments, contracting, payment processing); Tracking and reporting quality performance metrics; identify root causes of recurring errors and define corrective actions; Partnering with leadership to implement corrective training and process refinements; Leading process improvement and optimization; Serving as a key SME in continuous improvement initiatives, contributing to best practices across global operations; Mentoring junior team members; Supporting the process design and implementation of new client or new markets ensuring a high-level of customer engagement, quality, timeliness, and service-readiness across all regions; Managing deliverables on or ahead of deadlines and reporting any issues/risks beforehand; Experience in life science meetings & events, pharmaceutical device or healthcare setting working with HCPs, HCOs or Patients; Identifying opportunities for efficiency, automation, and standardization within the managed services delivery model; Working closely with the client-dedicated operations team to streamline processes while maintaining quality and compliance; Communicating with senior leadership and senior client stakeholders; Delivering "white glove" customer service; Ability to work in a fast-paced environment, with a strong emphasis on quality and accuracy; Monitoring and managing other responsibilities not necessarily listed but logically inherent to the role; Leading teams of individuals with a positive attitude; Strong English language reading comprehension and writing skills. Travel Requirements Up to 40% Job Posting End Date Learn more about how we work: https://pwc.to/how-we-work PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy . As PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all. Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: https://pwc.to/us-application-deadlines The salary range for this position is: $99,000 - $232,000. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. All hired individuals are eligible for an annual discretionary bonus. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link: https://pwc.to/benefits-at-a-glance

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist II/III as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Schedule: Wed-Sat, 1st Shift Key Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Support manufacturing activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs) Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. Support batch review & material release in SAP for In-house reagents. Support Floor Spot-check, audit trail review. Strive to reduce non-conformances in supported areas by proactively driving compliance. Support Investigations team by providing quality and compliance input for continuous improvement and remediations. Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor. Utilize multiple electronic quality systems, batch records and SAP. Work in a team based, cross-functional environment to complete tasks required to meet business objectives. Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time. Responsibilities will include but not limited to tasks mentioned above. Support regulatory inspections and audits as needed. Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements. Other duties will be assigned, as the need arises. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses Color Perception both eyes 5 slides out of 8. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning Requirements Bachelors degree required in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy. Experience with quality support in clinical manufacture is preferred. Flexible to work on weekends, as needed. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Is frequently required to communicate with coworkers. While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms. Ability to lift 20 lbs. Report to work on-time. Duties are required to be performed on-site at manufacturing facility. Perform other duties as assigned. Attend departmental and other scheduled meetings. Practice good interpersonal and communication skills. Demonstrate positive team-oriented approach in the daily execution of procedures. Promote and work within a team environment. Learn new skills, procedures and processes as assigned by management and continue to develop professionally. Support and contributes to projects. Assist in troubleshooting issues related to manufacturing. Technical knowledge within functional units Demonstrate an understanding of the process in order to properly perform the assigned tasks. Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems. Utilizes tools within MS Office and other systems to improve business effectiveness. Read and interpret documents such as safety rules, operating instructions, and logbooks. Review and provide feedback for SOPs. Interpret a variety of instructions furnished in written, oral, or diagram. Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals, Aseptic processing in ISO 5 clean room and biosafety cabinets. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #LI-BG1 #LI-Onsite The anticipated base pay range is $75,972-$99,713 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles. We offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes vacation days, personal days, sick time, 11 company holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Job Overview Wargaming is looking for а QA Engineer to work on World of Warships: Legends in our Belgrade office. World of Warships: Legends is a cross-platform gaming project in release on PS and XBOX consoles and in soft launch on mobile devices. The R&D team focuses on improving new players' experience as well as delivering fun and unique in-game events. Reports to R&D Team Lead What will you do? Design test plans, test cases, and prepare the test environment; Perform manual functional, regression, and acceptance testing on various platforms; Create and maintain errors in the bug tracker; Launch automated tests, analyze their results and prepare respective reports; Create and maintain up-to-date test documentation; Participate in planning new features for the project, analysis of new documentation, and interaction with development teams. What are we looking for? 2+ years of QA experience; Knowledge of testing methods and techniques; Experience in developing test scenarios (test cases and checklists); Experience with version control systems (Git, SVN); Experience with bug tracking systems; Experience with Testrail, Allure, or others; Understanding of performance testing Knowledge of JSON and XML; English Language B2 or higher; Readiness for full-time office work. What additional skills will help you stand out? Knowledge of SDLC; Understanding of client-server communication; Experience in GameDev; Experience in mobile/console games testing. Work mode Hybrid (2-3 days of work from the office) Benefits Benefits and perks are tailored to the local market and culture. Our benefits in Belgrade include: Additional vacation days based on years of service at Wargaming: up to 5 days on top of the statutory minimum Additional paid time off (5 Personal Days, Birthday Leave, Marriage Leave, Compassionate Leave) Sick Leave Compensation, Maternity Leave Benefits Premium Private Health Insurance Career development and education opportunities within the company English clubs and platform for learning languages Mental well-being program (iFeel) Commuting allowance Company events FitPass membership Discounts for employees Personal Gaming Account Coffee, fruits, and snacks in the office On-site canteen with subsidized prices for food and drinks Seniority Awards Referral program - you can recommend the best talents to the Company and receive a reward Please submit your CV in English to ensure smooth processing and review. About Wargaming Wargaming is an award-winning online game developer and publisher headquartered in Nicosia, Cyprus. Operating since 1998, Wargaming has become one of the leaders in the gaming industry with 15 offices worldwide, including studios in Chicago, Prague, Shanghai, Tokyo, and Vilnius. Our diverse and multicultural team works together to deliver a top-class experience to millions of players who enjoy Wargaming's titles across all major gaming platforms. Our flagship products include free-to-play hits World of Tanks, World of Warships and World of Tanks Blitz. Please see Wargaming Candidate Privacy Policy for details on how Wargaming uses your personal data.

Job Description Summary: We are seeking an outstanding individual to fill the position of Quality Assurance Coordinator at Aviagen's GGP Hatchery in Elkmont, AL. This role is a critical part of the Hatchery team to ensure Aviagen's quality objectives are maintained and to verify conformance of activities to quality assurance standards. This position will work closely with the GGP Hatchery and production teams and will report directly to the GGP QA and Regulatory Manager. Job Description: The ideal candidate should have the following experience, skills, and attributes: Bachelors of Science or equivalent preferred. Strong computer skills including Microsoft Excel (with Pivot Tables), PowerPoint, and Word. Must be able to perform occasional physically demanding aspects of the job. Able to work flexible hours and weekends. Above average math skills and problem-solving abilities, with an emphasis on data collection and analysis. Knowledge of hatchery and poultry operations preferred. Knowledge and familiarity with sampling procedures to include bacterial and mold monitoring. Detail oriented, professional, strong organizational skills, and self-motivated. Preferred understanding of ISO 9001:2015 or equivalent. Preferred knowledge of hatchery and poultry operations. Key Responsibilities: The following duties will vary according to the needs of the organization. Normal duties will include, but are not limited to, the following: Quality assurance checks on day old chicks and eggs. Assist in revising and updating the quality assurance manual and procedures. Observe and ask employees questions pertaining to job functions. Maintain strong communication with the GGP Hatchery management team, and interact and communicate with all levels of facility personnel. Read processing information such as worker logs, product processing sheets, and specification sheets to verify that records adhere to quality assurance specifications. Aptitude to determine appropriate corrective actions and root cause analysis. Perform routine facility monitoring, tests, and sample collection. Interact and communicate with all levels of hatchery personnel. Recognize problems and opportunities for improvement that may affect quality, and aid in coming up with and implementing solutions (determine appropriate corrective actions and root cause analysis). Write and submits report to hatchery supervisory personnel and QA Management team. Maintain and upload paperwork in a timely manner. Follow policies and procedures related to animal welfare, biosecurity, and compartmentalization. Other duties as determined by QA Management team. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Who You Are At least 3 years of experience as a Manual QA Engineer and Automation developer for enterprise products. B.Sc. in Computer Science or other relevant fields Experience in requirements analysis, test plan writing and execution. Experience with any of these programming languages: JavaScript / TypeScript / Java / Python / C# Familiarity with UI Automation frameworks (Selenium, Cypress, Playwright) Knowledge of common testing frameworks (Jira based) Ability to find and analyze system and software problems quickly and accurately Familiarity with SQL and/or NoSQL DBs Excellent spoken and written English Strong analytical skills Financial knowledge is an advantage Experience with the Cucumber open-source tool supporting Behavior-Driven Development is an advantage Responsibilities: Responsible for the quality of the functionality of Capitolis products Execute Tests for existing and new features of Capitolis products Represent the QA discipline in a scrum team, create, review and execute manual and test plans Writing STD/STP Testing of UI, web services Analyze and validate clients' issues Working in a fast paced agile environment Plan and create high-quality automated end-to-end test cases Execute, analyze and maintain automated tests Work closely with Developers, QA, Product and DevOps The target annual base salary range for this position is $130,000 - $140,000 and is dependent on a variety of factors, including, but not limited to, job-related experience, qualifications, knowledge, and skills. In addition to base salary, the compensation package for this role includes an annual discretionary bonus and company equity. This role is also eligible to participate in company-sponsored benefits and perks.

Position Overview: We are looking for a self-motivated Senior Software QA Engineer to be a part of the testing effort related to product development and product modifications. The position is responsible for ensuring that the design changes for on-market and new products is effectively and efficiently verified and validated prior to its release and that these designs effectively meet their requirements. Software quality assurance efforts are lifecycle oriented, beginning during product requirements development and continuing throughout its lifetime. Responsibilities: Designs, develops, tests and documents embedded system software for new and existing Insulet products. Ensures that their design is in compliance with Company policies, and that software activities are appropriate for the design and maintenance of medical products. Collaborate with Development, QA and IT teams Work closely with the software development team to identify and correct defects. Participate in product design reviews. Perform other duties as required Education and Experience: Minimum Requirements: BS in Software Engineering, Computer Science or similar field; 10+ years of experience in software design and software testing. Master's degree preferred. Experience with medical device software development. A minimum of 5+ years work experience in Software Quality Engineering within an FDA, ISO or other regulated environment Experience on processors like ARM, TI and MSP (or similar Embedded Systems/Microcontrollers) is required. Experience with software design V&V, computerized systems validations, and process validations. Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.). Experience with software development lifecycles with emphasis on the software quality engineering aspects Hands-on experience with Embedded Systems is required. Self-motivated, proactive and quick learner Skills/Competencies: Preferred Skills and Competencies: Demonstrated working knowledge of software design. Experience developing software for embedded microcontrollers. Knowledge of I2C, SPI, Flash, EEPROM and/or USB preferred. Familiarity with communication systems and/or wireless protocols will be a plus. Medical device experience is preferred. Able to work independently with minimum supervision. Able to be responsible for designing, implementing, and maintaining a section of a design. Detail oriented, with effective verbal and written communication skills. Able to communicate with candor and trust at multiple levels of the organization. Demonstrated abilities to leverage creativity in order to overcome obstacles and work with a sense of urgency. Strong software engineering development skills. In-depth Object oriented programming is useful. Familiar with reading electrical schematics is a plus. Able to organize and judge multiple priorities. Agile or other software development life cycle concepts is a plus. Knowledge of Wireless protocols like Bluetooth Low Energy (BLE) is a plus. Physical Requirements: General office environment, may sit for long periods of time. Able to work effectively in a high-stress, high-energy environment. NOTE: This position is eligible for hybrid working arrangements (requires on-site work from our Acton, MA office; may work remotely other days). #LI-Hybrid Additional Information: The US base salary range for this full-time position is $94,725.00 - $142,087.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights)

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist II/III as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Schedule: Wed-Sat, 2nd Shift Key Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Support manufacturing activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs) Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. Support batch review & material release in SAP for In-house reagents. Support Floor Spot-check, audit trail review. Strive to reduce non-conformances in supported areas by proactively driving compliance. Support Investigations team by providing quality and compliance input for continuous improvement and remediations. Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor. Utilize multiple electronic quality systems, batch records and SAP. Work in a team based, cross-functional environment to complete tasks required to meet business objectives. Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time. Responsibilities will include but not limited to tasks mentioned above. Support regulatory inspections and audits as needed. Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements. Other duties will be assigned, as the need arises. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses Color Perception both eyes 5 slides out of 8. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning Requirements Bachelors degree required in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy. Experience with quality support in clinical manufacture is preferred. Flexible to work on weekends, as needed. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Is frequently required to communicate with coworkers. While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms. Ability to lift 20 lbs. Report to work on-time. Duties are required to be performed on-site at manufacturing facility. Perform other duties as assigned. Attend departmental and other scheduled meetings. Practice good interpersonal and communication skills. Demonstrate positive team-oriented approach in the daily execution of procedures. Promote and work within a team environment. Learn new skills, procedures and processes as assigned by management and continue to develop professionally. Support and contributes to projects. Assist in troubleshooting issues related to manufacturing. Technical knowledge within functional units Demonstrate an understanding of the process in order to properly perform the assigned tasks. Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems. Utilizes tools within MS Office and other systems to improve business effectiveness. Read and interpret documents such as safety rules, operating instructions, and logbooks. Review and provide feedback for SOPs. Interpret a variety of instructions furnished in written, oral, or diagram. Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals, Aseptic processing in ISO 5 clean room and biosafety cabinets. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #LI-BG1 #LI-Onsite The anticipated base pay range is $75,972-$99,713 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles. We offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes vacation days, personal days, sick time, 11 company holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist." Why Join Diasorin? Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world. Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry. Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive. Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward. Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact! Job Scope Responsible for evaluating and optimizing manufacturing, and CAPA processes to improve product consistency ensure regulatory compliance and increase productivity. Responsible for end-to-end validation lifecycles for new and existing products while applying strong business acumen to balance quality requirements with operational efficiency. Supports all applicable regulations including but not limited to FDA, ISO13485. Responsibilities and Duties Review of design, manufacturing, purchasing, and test documentation to ensure quality requirements are fulfilled. Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis. Provide leadership in and employ advanced quality planning techniques (FMEA, Capability Studies, Measuring and Test Equipment Studies, Product Validation and Reliability Test) Assist in determining process/equipment capabilities. Assist in the development of process flow diagrams and perform gap analyses on current controls versus required controls. Investigate the root cause of external and internal non-conforming products. Drive corrective and preventive actions and verifications of effectiveness such as actions for customer complaints, internal audits, and internal and external suppliers non-conformance. Perform assessments of process-related risks, bridging the gap between technical quality requirements and business goals to support strategic decision-making. Assist in the development of inspection procedures and justified sample plans. Develop and maintain systems to collect, analyze, and report data reflecting status of product and process and provide recommendation to improve. Represent quality on new product development teams for design transfer with guidance from more senior quality engineers or management. Apply project management principles to lead continuous improvement and Lean initiatives. Perform other duties as assigned. Education, Experience and Qualifications Education: Bachelor's Degree and/or equivalent experience in a Life Sciences discipline (Biochemistry, Chemistry, Microbiology, etc.) or Engineering discipline (Mechanical, Electrical or Industrial Engineering). Experience: 2+ Years related experience in IVD, medical, pharmaceutical, or other related industry. Proven experience in Process, Product, and/or Method Validation is required. Licenses and Certifications ASQ Certified Quality Engineer preferred. Training and Skills Must have a thorough understanding of statistical quality control, statistical process control, Corrective Action Process, and their application manufacturing as a problem identification and resolution tool. Proficient in Advanced SPC, Quality Analysis Tools (Taguchi, Fishbone) & DOE. FDA Process Validation Techniques preferred Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department. Nearest Major Market: Austin

In the Technology division, we leverage innovation to build the connections and capabilities that power our Firm, enabling our clients and colleagues to redefine markets and shape the future of our communities. This is a QA Engineering III position at Director level, which is part of the job family responsible for devising test strategies, conducting and/or coordinating tests, and identifying defects to maintain high standards of performance and reliability. Morgan Stanley is an industry leader in financial services, known for mobilizing capital to help governments, corporations, institutions, and individuals around the world achieve their financial goals. Interested in joining a team that's eager to create, innovate and make an impact on the world? Read on. As a Test Automation Engineer you will manage QE teams delivering both manual and automated quality testing for financials and securities trading front-end applications. Your understanding of security financial data and securities trading, your experience leading testing of front-end web applications, and your collaborative yet firm approach to getting things done will be critical to your success in this role. This is an individual contributor role requiring hands-on experience in test automation, mobile and API testing along with leadership capabilities to guide and collaborate with offshore teams. What you'll do in the role: Design, develop, and execute manual and automated test cases for web, mobile and API applications Ensure end-to-end quality by implementing testing strategies, automation frameworks, and best practices Work closely with developers, product and business stakeholders to align testing efforts with project requirements Act as a bridge between onshore and offshore QA teams, ensuring smooth coordination, knowledge sharing and timely issue resolution Drive and mentor QA team providing technical guidance and ensuring best QA practices are followed Collaborate in Agile environments, actively participating in sprint planning, stand-ups and retrospectives Continuously improve testing processes, identify gaps and implement automation where feasible. Ensure production roll testing staffing and attend production rolls as needed Coordinate tool enhancement needs with infra/tools team Communicate on team's behalf to both technical and non-technical audiences Work in an agile environment with various scrum teams, using test management tools such as JIRA / XRAY What you'll bring to the role: Bachelor's degree or equivalent combination of technical education and work experience 7+ years of experience in information technology/software development with a proven ability to ensure high quality results and with expertise in test automation, agile methodologies and QA best practices. Strong hands-on experience in Java Selenium for UI automation Demonstrated knowledge of Financials and securities trading instruments offered on Morgan Stanley/E*TRADE Solid knowledge of QA methodologies, test planning, system dependencies, and product integration phases Ability to lead teams in a fast-paced environment with short sprint cycles Exposure to the Atlassian tool sets, Bitbucket, JIRA, Confluence, etc. Experience in mobile testing and API testing using tools like postman, Rest Assured Excellent communication and coordination skills, with the ability to collaborate effectively with onshore and offshore teams Preferred Qualifications: BS or MS degree in Computer Science, Information Systems, or Engineering Experience with Jenkins, Git, BitBucket, Perfecto, SauceLabs cloud, Java, Selenium WHAT YOU CAN EXPECT FROM MORGAN STANLEY: We are committed to maintaining the first-class service and high standard of excellence that have defined Morgan Stanley for over 89 years. Our values - putting clients first, doing the right thing, leading with exceptional ideas, committing to diversity and inclusion, and giving back - aren't just beliefs, they guide the decisions we make every day to do what's best for our clients, communities and more than 80,000 employees in 1,200 offices across 42 countries. At Morgan Stanley, you'll find an opportunity to work alongside the best and the brightest, in an environment where you are supported and empowered. Our teams are relentless collaborators and creative thinkers, fueled by their diverse backgrounds and experiences. We are proud to support our employees and their families at every point along their work-life journey, offering some of the most attractive and comprehensive employee benefits and perks in the industry. There's also ample opportunity to move about the business for those who show passion and grit in their work. Morgan Stanley's goal is to build and maintain a workforce that is diverse in experience and background but uniform in reflecting our standards of integrity and excellence. Consequently, our recruiting efforts reflect our desire to attract and retain the best and brightest from all talent pools. We want to be the first choice for prospective employees. It is the policy of the Firm to ensure equal employment opportunity without discrimination or harassment on the basis of race, color, religion, creed, age, sex, sex stereotype, gender, gender identity or expression, transgender, sexual orientation, national origin, citizenship, disability, marital and civil partnership/union status, pregnancy, veteran or military service status, genetic information, or any other characteristic protected by law. Morgan Stanley is an equal opportunity employer committed to diversifying its workforce (M/F/Disability/Vet).

Automation Tester (Software Quality Assurance) We are currently searching for a dynamic software quality assurance automation engineer with experience in Node.JS based Automated testing tools like Playwright/Cypress/ WebDriver IO, and a strong understanding of SDLC to join our team here at Rooms To Go. You will be responsible for ensuring software quality through the development and execution of software test scripts by way of verification procedures based upon software and system specifications. Responsibilities: Automate regression, Smoke tests and other repeatable tests Document/ report bugs Qualifications: At Least 4-6 yrs of Automation Experience (can be any tool, with at least 2 or more years of experience working with Node JS based tools) Exposure to automation framework designing Experience with Playwright tool Experience with Java script Experience with Automation Frameworks Strong Analytical & Problem-Solving skills Should be ready to adapt to new technology and improve skills as needed Should be a good communicator Founded in 1991, Rooms To Go is one of the largest and fastest growing furniture retailers in the US with over 250 stores in ten southern states, eight distribution centers and an e-commerce business. Rooms To Go offers a collaborative work environment within a supportive culture. Rooms To Go Benefits: Medical, dental, and vision insurance 401(k) with company match Associate discounts including furniture Company paid life and disability insurance Paid time off Employee Assistance Program Wellness Programs And more! Rooms To Go is an equal opportunity employer. We do not discriminate in hiring or employment against any individual on the basis of race, color, gender, national origin, ancestry, religion, physical or mental disability, age, veteran status, sexual orientation, gender identity or expression, marital status, pregnancy, citizenship, or any other factor protected by anti-discrimination laws Applicants must be authorized to work in the U.S.

SUMMARY/JOB PURPOSE: The Senior Operations QA Clinical GLP Manager is accountable for assisting in the development, implementation and maintenance of end-to-end QA processes and activities, including GLP operations. Provide Operations QA oversight of day-to-day end-to-end (Drug Substance, Drug product, Finished Goods) GMP Operations at the Contract Manufacturing Organizations (CMOs) that manufacture and test Exelixis development and clinical products, including batch record review, assessment, rapid escalation and issue resolution, release per supply plans, and managing product complaints. Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions, internally or externally, and QA, to provide and ensure delivery on the company core goals and pipeline deliverables. Manages Exelixis partnerships, collaborations. audits, forges strong relationships to maintain performance and continuous improvement. Demonstrates a high level of independent quality judgment and acumen, and knowledge and experience with GLP regulations, biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape. ESSENTIAL DUTIES/RESPONSIBILITIES: Represent QA as the QA Partner (Primary Point of Contact) (vendors, CMOs, development collaborators for contracts, validation, change management, GMP and GLP issues). Develop, implement, and continuously improve QA programs, policies and procedures to ensure GMP and GLP compliance of clinical trial material, and onsite labs. Perform record review, and batch disposition for commercial and clinical trial material, including comprehensive Quality assessment, and review of GLP documents and records. Oversee CMOs and GLP vendors, as applicable: Issue/deviation management, CAPAs with vendors and cross-functional teams to resolve potential product quality issues, rapidly escalate and resolve issues. Generate, review/approve internal and external GMP records (MBR and EBR (master and executed batch records), stability reports/protocols, specifications, deviations, change controls, testing and labeling/packaging records, development/CMC documents submitted to regulatory agencies, GLP documents and records, etc.) Responsible for developing, tracking and managing periodic management reports, including key GMP and GLP compliance and QA metrics, as applicable. Maintain and report CMO metrics and Operations QA metrics. Evaluate and generate data to support KPIs (Key Performance Indicators). Identify and rapidly mitigate risk. Independently determines approach to complex compliance issues and rapidly escalates reports findings, with recommendations for resolution, and verifies that appropriate CAPAs were implemented and documented. Contribute to APQR (annual product quality review) as applicable. Support implementation of quality systems, departmental and corporate procedures, to ensure compliance with cGMPs and GLP. Partners with Regulatory Affairs, Clinical Pharmacology, Translational Medicine, PSC, PSC Analytical, and R&D as it pertains to GLP, etc., regarding compliance issues, provides compliance guidance to all audited parties. Maintains knowledge of current regulation requirements; informs stakeholders of potential impact on the organization. Deliver per supply plans, drive results. SUPERVISORY RESPONSIBILITIES: No supervisory responsibilities. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience; or, Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience; or, PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience; or, Equivalent combination of education and experience. Experience: A minimum of 8 years of related QA experience or the equivalent combination of experience and education/training. Experience in the biotech or pharmaceutical industry, and clinical packaging/labeling activities is preferred Two years' experience managing Contract Manufacturing Organizations preferred Five years general experience in biotech/pharmaceutical industry. Experience in development of metrics and continuous improvements is preferred Knowledge, Skills and Abilities: Demonstrated knowledge of the drug development processes Demonstrated GLP audit conduct and management experience is required. Working knowledge of supporting GLP preparation and submission activities for global regulatory filings. Working knowledge of the end-to-end commercial and clinical manufacturing and quality processes, including US/EU regulations affecting the pharmaceutical industry, and ICH guidelines. Proven experience in a virtual manufacturing environment or relevant industry/profession. Requires a broad range of knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, laboratory practices and tox studies, and understanding of the international regulatory landscape. Small molecule, oral solid form, biologics technical knowledge required. Uses broad expertise or unique knowledge and skills to drive meeting company core objectives and principles, and to achieve goals in creative and effective ways. Implements technical solutions within quality requirements to complex problems. Interprets, executes and recommends modifications to companywide policies and/or divisional programs. Great attention to detail. Applies strong analytical and business communication skills. Evaluates and generates data to support departmental metrics. Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization. Excellent MS Office, Word, Excel and PowerPoint skills. Work Environment/Physical Demands: This is an onsite position Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. This position requires up to 5% travel. #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $165,000 - $235,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Company: NICO National Indemnity Company Want to work for a company with unparalleled financial strength and stability that offers “large company” benefits with an exciting, friendly, and “small company” atmosphere? Our companies, as members of the Berkshire Hathaway group of Insurance Companies, provides opportunities for professionals interested in just that. Software Quality Assurance Specialist Directs and participates in designing, creating, testing, and implementing automated testing to reduce risk and time to value for software products. Acts as a team lead for technical questions related to testing coverage and practices involving product interactions, complex work orders, and functionality of new features within software products. Champions testing and quality mindset within the team. This position will be with National Indemnity Company in Omaha, NE with a hybrid 50% in the office work environment. This position is not eligible for employer visa sponsorship. #LI-Hybrid / #LI-Onsite What will you do? Plan testing (e.g., regression, functional, data validation, system integration, load, or performance tests) for new and existing functionality. Works closely with teams to design testing strategies and integrate testing into the software development lifecycle to execute on test plans. Identifies opportunities to reduce testing time and effort by automating repeatable tests. Executes and implements test cases, working with engineers, product partners, and business stakeholders. Documents and analyzes test results and recommends corrective action. What are we looking for? Bachelor's degree in computer science, information-technology or related field, or equivalent experience. Minimum 3+ years related work experience. Knowledge of Agile methodologies (Scrum, Kanban, etc.) Knowledge of software development practices and procedures Experience working with Selenium, C#, Postman, and related technologies Who would excel in this role? Someone with familiarity with continuous delivery and continuous integration Someone with strong interpersonal skills including conflict resolution skills Someone with insurance industry and product knowledge Experience with application performance monitoring and observability tools. Strong knowledge of agile practices and experience with agile planning tools (e.g. Azure DevOps). We want you to be involved! We offer Employee Resource Groups for volunteering, connecting with others, social gatherings, and professional development. We also regularly seek employees input through companywide surveys. We care about your health and wellbeing! Our Wellness program is integrated into the Company culture with an online wellness portal that offers a year-round, one-stop-shop to manage and track all areas of health, our Omaha office boasts a complimentary state-of-the-art onsite fitness center, and a robust wellness program. Benefits, Perks and more! We offer retirement and savings plan with immediate enrollment with 100% employer match up to 5%, Medical, Dental and Vision for regular, full-time employees and eligible dependents, a dedicated Learning & Development program for employees to grow personally and professionally, 100% upfront Educational Reimbursement program, subsidized downtown parking, competitive time off policies including parental leave, an Employee Assistance program and much more!

Prysmian is the world leader in the energy and telecom cable systems industry. Each year, the company manufactures thousands of miles of underground and submarine cables and systems for power transmission and distribution, as well as medium low voltage cables for the construction and infrastructure sectors. We also produce a comprehensive range of optical fibers, copper cables and connectivity for voice, video and data transmission for the telecommunication sector. We are 30,000 employees, across 50+ countries. Everyone at Prysmian has the potential to make their mark; because whatever you do, wherever you are based, you will be part of a company that is helping transform the world around us. Make Your Mark at Prysmian Group- Join Us Comprehensive Benefit Package including Medical, Dental, Vision and Life Insurance. 401K Savings Plan with Company Matching Contributions, Paid Holidays and Vacation. Overview: The QA Lab Tech ensures product compliance at the point of production, laboratory testing, data analysis, and support for root cause investigations. This role is key in maintaining quality standards and driving continuous improvement on the manufacturing floor. Compensation: $25.80/hr Schedule: 2-2-3 12-hour shift (day/night shift available) Training Hours: Mon-Fri 7am- 3pm Job Duties: Support production by being a QA presence at production lines. Interact with operators and helpers to ensure standard work is done consistently. Provide technical support for lab operations. Select and test products at various production stages. Perform destructive and non-destructive testing. Collaborate with management and engineering on standards. Follow safety and procedural guidelines strictly. Record and evaluate test data, noting deviations. Input data into analysis systems. Execute routine tasks accurately and timely. Serve as a quality contact for operators and helpers. Conduct and document production audits. Maintain a quality presence in production areas. Perform other reasonable tasks as assigned. Key Job Requirements: Results-driven with manufacturing experience. Adaptable to fast-paced environments. Detail-oriented with big-picture awareness. Skilled in multitasking under pressure. Strong communicator and motivator. Critical thinker with analytical skills. Proficient in written and verbal communication. Strong planning, leadership, and computer skills. Desired Background: 2-4 years in wire and cable or related industry. Experience with various software systems. Project management and Lean Manufacturing familiarity. Work Environment and Physical Requirements: Ability to stand for extended periods of time (up to 8-10 hours per shift). Ability to walk long distances within the plant and between workstations. Ability to lift and carry up to 40 pounds occasionally. Manual dexterity and ability to handle small tools and lab equipment. Ability to bend, stoop, reach, and perform repetitive motions as needed. Tolerance to working in varying environmental conditions (e.g., heat, noise) Prysmian, as an Equal Opportunity Employer, aims to attract and recruit individuals with diverse backgrounds, skills, and abilities. We strongly believe that diversity brings significant value at all levels of the organization, increasing the possibility of capturing market opportunities and maximizing value for our customers and stakeholders. With Diversity, Equity, and Inclusion (DE&I) as part of our Social Ambition 2030 and a strategic pillar of our Company culture, Prysmian is committed to the development of an organization that prioritizes talent, where people feel respected, included, and free to fully express their potential just as they are. All Managers and HRs in Prysmian are responsible for ensuring DE&I policies are respected during the recruiting process, as well as recognizing and mitigating unconscious biases that must not influence our selection processes. All persons will be considered for employment without regard to their race, ethnicity, religion, nationality, origin, citizenship status, socio-economic status, age, sex, gender identity or expression, sexual orientation, marital status, disability, military service or veteran status, pregnancy, parental leave, medical conditions, or any other characteristic protected by applicable federal, state or local laws. Prysmian will endeavor to make a reasonable accommodation for any disclosed physical or neurological condition or disability of a qualified applicant unless the accommodation would impose an undue hardship on the operation of our business. Visit our DE&I Page to learn more about Prysmian's commitments. Your application data will be treated according to our Data Protection Policy. If you believe you require assistance to complete this form or to participate in an interview, please contact us at talent.mobility@prysmiangroup.com. https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf https://www.dol.gov/sites/dolgov/files/OFCCP/regs/compliance/posters/pdf/22-088_EEOC_KnowYourRights.pdf https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ. Role Overview The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide quality oversight for technical teams. Key Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities. Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations. Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol-driven activities such as tech transfer and process validation. Assist in the development of process, operational, and quality improvements for manufacturing. Assist in the review and development of process-related protocols and documentation. Provide technical quality oversight for electronic batch records. Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems. Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations. Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions. Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities. Ability to work independently perform assigned tasks. Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. May support CSV activities as needed. May support equipment qualification activities as needed. Drive continuous improvement. Requirements A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required. 5+ years relevant work experience or equivalent. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A portion of the 5 years must include quality assurance experience. Strong knowledge of cell therapy processes strongly preferred. Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred. Experience with Computer System Validation (CSV) is a plus. Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience reviewing/auditing GMP documentation. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and make critical decisions with limited information. Ability to work independently and escalate to management when required. Detail-oriented and able to follow procedures closely. Ability to identify and assess possible gaps and work collaboratively to address such issues. Must be highly organized and capable of working in a team environment with a positive attitude. Strong proficiency with using Microsoft Office applications. #Li-RP1 #Li-Onsite The anticipated base pay range is $75,972-$99,713 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles. We offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes vacation days, personal days, sick time, 11 company holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Position Overview:We are looking for a self-motivated Senior Software QA Engineer to be a part of the testing effort related to product development and product modifications. The position is responsible for ensuring that the design changes for on-market and new products is effectively and efficiently verified and validated prior to its release and that these designs effectively meet their requirements. Software quality assurance efforts are lifecycle oriented, beginning during product requirements development and continuing throughout its lifetime. Responsibilities: Designs, develops, tests and documents embedded system software for new and existing Insulet products. Ensures that their design is in compliance with Company policies, and that software activities are appropriate for the design and maintenance of medical products. Collaborate with Development, QA and IT teams Work closely with the software development team to identify and correct defects. Participate in product design reviews. Perform other duties as required Education and Experience: Minimum Requirements: BS in Software Engineering, Computer Science or similar field; 10+ years of experience in software design and software testing. Master’s degree preferred. Experience with medical device software development. A minimum of 5+ years work experience in Software Quality Engineering within an FDA, ISO or other regulated environment Experience on processors like ARM, TI and MSP (or similar Embedded Systems/Microcontrollers) is required. Experience with software design V&V, computerized systems validations, and process validations. Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.). Experience with software development lifecycles with emphasis on the software quality engineering aspects Hands-on experience with Embedded Systems is required. Self-motivated, proactive and quick learner Skills/Competencies: Preferred Skills and Competencies: Demonstrated working knowledge of software design. Experience developing software for embedded microcontrollers. Knowledge of I2C, SPI, Flash, EEPROM and/or USB preferred. Familiarity with communication systems and/or wireless protocols will be a plus. Medical device experience is preferred. Able to work independently with minimum supervision. Able to be responsible for designing, implementing, and maintaining a section of a design. Detail oriented, with effective verbal and written communication skills. Able to communicate with candor and trust at multiple levels of the organization. Demonstrated abilities to leverage creativity in order to overcome obstacles and work with a sense of urgency. Strong software engineering development skills. In-depth Object oriented programming is useful. Familiar with reading electrical schematics is a plus. Able to organize and judge multiple priorities. Agile or other software development life cycle concepts is a plus. Knowledge of Wireless protocols like Bluetooth Low Energy (BLE) is a plus. Physical Requirements:General office environment, may sit for long periods of time.Able to work effectively in a high-stress, high-energy environment. NOTE: This position is eligible for hybrid working arrangements (requires on-site work from our Acton, MA office; may work remotely other days). #LI-Hybrid Additional Information: The US base salary range for this full-time position is $94,725.00 - $142,087.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. ( Know Your Rights )

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are You bring a wealth of Quality Assurance knowledge to the table and are eager to build and grow a QA team around you. You're able to pivot at a moment's notice between utilizing your individual expertise and mentoring or developing a member of your team. The Associate Director, QA Engineering will provide advanced support and subject matter technical expertise and utilize industry best practices to maintain cGMP compliance for UTC combination products, clinical materials supply, and new product development of active pharmaceutical ingredients (API), drug substances, drug products, and combination product/medical devices. This role will manage and support the new product development activities through product and process development and improvement, implementation of product/process verification, validation activities, and commercialization. Responsibilities for this role also include oversight and leadership of the Change Control, Quality Event, and CAPA programs and supporting management during regulatory agency(ies) inspections, third-party partners, and customer audits. Work independently and as part of a multi-functional team to manage, lead, and prioritize workloads, complex projects/tasks, departmental initiatives, and deadlines Manage quality engineering input and provide advanced technical expertise to processes and manufacturing documentation, including complex data analysis, material specifications, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested and that compliance to quality systems procedures, regulations, and standards are achieved Support the trending and reporting of CAPA activities. Lead investigations and serve as an internal expert for Risk Assessments, Quality Events, Investigations, Out of Specifications (OOS), Change Controls, Exceptional Conditions, and Corrective and Preventive Action (CAPA) processes for GxP events Interact regularly with peers and senior management across multiple functional groups (e.g., Research and Development, Manufacturing, Validation, Regulatory Affairs, etc.). Negotiate and manage expectations across functional groups for project timelines and quality requirements Lead and manage quality engineering activities and provide SME support for project start-up and the technology transfer of new products or methods into existing manufacturing operations. Responsible for evaluating new technologies against applicable guidance, and industry practices Provide support during external, internal, and health agency audits Author, collaborate, analyze, and approve cGxP related documents (i.e., product/ design specifications, computerized systems, validation protocols and reports (IOQ/PQ), analytical/microbiological method validations, stability protocols, operational protocols and reports, Site Master Files, DHF, DMR, etc.) for accuracy, completeness, and compliance with cGMP and UTC policies, procedures, and requirements Participate in supplier selection process and specification reviews as necessary Participate in, and/or lead, quality system, process and product-related decisions. Recommend and manage changes to policies and establishes procedures affecting immediate function/group Collaborate with different members of the QA/RA departments working on special projects Manage, lead, and support quality system project initiatives and continuous process verification. Through continuous oversight, identify gaps and coordinate resolution, and quality improvement initiatives Coordinate and lead internal mock audits in preparation of the site readiness for health agency inspections Mentor peers on technical information on projects, mock audits and recalls, and other areas of expertise Direct and manage team to include responsibilities for goal setting, performance reviews/management, coaching, mentoring and career development For this role you will need Minimum Requirements Bachelor's Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline or Master's Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline 12+ years of experience in quality assurance, quality engineering and management in the FDA regulated environment or a related industry with Bachelor's degree or 10+ years of experience in quality assurance, quality engineering and management in the FDA regulated environment or a related industry with Master's degree 5+ years of experience leading multi-discipline engineering projects with previous participation in regulatory inspections Ability to manage, mentor, and/or provide technical guidance to other engineers/project team members Clear understanding and application of QA and cGMP principles, concepts, industry practices, and standards Able to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines Demonstrated expertise with FDA Quality System regulations and cGMP, ISO 13485, ISO 14971, ISO 10993, IEC 60601, IEC 62304, 21 CFR Part 11, 210, 211, and 820 Clear understanding of US FDA, EU, and JP GMP regulations Knowledge of software validation practices and data integrity initiatives Familiarity with pharmaceutical operations (i.e., aseptic filling, etc.), solid oral dose, biologics operations, medical devices, and combination products Strong technical writing skills Strong experience in regulatory inspections Strong computer skills and demonstrated competence to include MS Office applications, database applications, and spreadsheet in a network environment Able to work independently with occasional to no need for guidance Strong organizational skills and strong attention to detail Preferred Qualifications Strong experience with validation and facility qualification Experience in process development activities for manufacturing/ assembly operations Knowledge of Laboratory Information Management System (LIMS), Systems Application and Product (SAP), MasterControl, MiniTab, Trackwise, and Empower software systems Continuous Process Validation experience Knowledge of software validation practices and data integrity initiatives Job Location United Therapeutics requires this candidate to be 100% on-site at our Durham, NC locations. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.

Principal Software QA Engineer This role has been designed as ''Onsite' with an expectation that you will primarily work from an HPE office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live and work. We help companies connect, protect, analyze, and act on their data and applications wherever they live, from edge to cloud, so they can turn insights into outcomes at the speed required to thrive in today's complex world. Our culture thrives on finding new and better ways to accelerate what's next. We know varied backgrounds are valued and succeed here. We have the flexibility to manage our work and personal needs. We make bold moves, together, and are a force for good. If you are looking to stretch and grow your career our culture will embrace you. Open up opportunities with HPE. Job Description: As a Principal QA Engineer at HPE, you will be the quality champion for customer-facing networking solutions, ensuring that every feature-from telemetry to routing protocols-delivers exceptional reliability, performance, and user experience. Your work directly impacts how customers monitor, manage, and scale their networks with confidence. The Principal QA Engineer at Hewlett Packard Enterprise (HPE) is a technical leader in quality assurance, responsible for driving test strategy, automation, and validation for networking platforms. This role focuses on telemetry systems, routing protocols (BGP, OSPF, MPLS), and platform-level testing to ensure reliability, scalability, and security across HPE's Juniper networking solutions. Lead the test automation strategy; evaluate and integrate new tools to improve efficiency and coverage Collaborate closely with product, development, support, and platform engineering teams to ensure full lifecycle quality coverage Provide technical leadership and mentorship to QA engineers and partners across teams Contribute to design reviews with a QA lens to ensure testability and risk mitigation Technical Expertise 16+ years of hands-on Networking and QA experience, including: Designing and building test automation frameworks from scratch Non-functional testing (scale, reliability, performance, security) Strong coding skills in Python; experience with Pytest Deep understanding of: Microservices, Containers (Docker, Kubernetes) Linux/VM environments, Storage, Compute, Networking REST APIs, JSON, SQL/NoSQL Experience with virtualization technologies like KVM or VMware Familiarity with performance and load testing tools Exposure to cloud-native testing challenges in private cloud environments Leadership & Collaboration Strong analytical and troubleshooting skills Excellent verbal and written communication Proven experience mentoring junior team members and driving cross-functional collaboration Knowledge/Skills Knowledge of complete SDLC and experience in software testing methodology, tools, developing test strategy, test planning and test execution. Strong automation background to be able to own automation strategy and tools required to build a test framework. Strong troubleshooting and analytical skills. Self-motivated with excellent verbal and written communication skills. Ideal candidates will have at least 13+ years of relevant experience in developing and supporting automation test frameworks from ground up. Proficiency in programming in Python & Golang. Experience in the following areas/technologies: IPv4, IPv6, MPLS, LDP, BGP, OSPF, ISIS, LLDP, STP, ACL, QoS, Policer, Multicast, Security; SRX-4600 and JunSOS Space Test Automation using Pytest Python, Spirent and IXIA Test/Traffic generator equipment Detailing of Network Designs and Implementation JNCIE preferred Docker, , Containerization, Kubernetes CI/CD, Git/Gitlab, Jenkins LINUX/VM environments Networking background KVM Additional Skills: Cloud Architectures, Cross Domain Knowledge, Design Thinking, Development Fundamentals, DevOps, Distributed Computing, Microservices Fluency, Full Stack Development, Security-First Mindset, Solutions Design, Testing & Automation, User Experience (UX) What We Can Offer You: Health & Wellbeing We strive to provide our team members and their loved ones with a comprehensive suite of benefits that supports their physical, financial and emotional wellbeing. Personal & Professional Development We also invest in your career because the better you are, the better we all are. We have specific programs catered to helping you reach any career goals you have - whether you want to become a knowledge expert in your field or apply your skills to another division. Unconditional Inclusion We are unconditionally inclusive in the way we work and celebrate individual uniqueness. We know varied backgrounds are valued and succeed here. We have the flexibility to manage our work and personal needs. We make bold moves, together, and are a force for good. Let's Stay Connected: Follow @HPECareers on Instagram to see the latest on people, culture and tech at HPE. #unitedstates #networking Job: Engineering Job Level: TCP_05 "The expected salary/wage range for this position is provided below. Actual offer may vary from this range based upon geographic location, work experience, education/training, and/or skill level. United States of America: Annual Salary USD 172,000 - 349,000 in California The listed salary range reflects base salary. Variable incentives may also be offered." Information about employee benefits offered in the US can be found at https://myhperewards.com/main/new-hire-enrollment.html HPE is an Equal Employment Opportunity/ Veterans/Disabled/LGBT employer. We do not discriminate on the basis of race, gender, or any other protected category, and all decisions we make are made on the basis of qualifications, merit, and business need. Our goal is to be one global team that is representative of our customers, in an inclusive environment where we can continue to innovate and grow together. Please click here: Equal Employment Opportunity. Hewlett Packard Enterprise is EEO Protected Veteran/ Individual with Disabilities. HPE will comply with all applicable laws related to employer use of arrest and conviction records, including laws requiring employers to consider for employment qualified applicants with criminal histories. No Fees Notice & Recruitment Fraud Disclaimer It has come to HPE's attention that there has been an increase in recruitment fraud whereby scammer impersonate HPE or HPE-authorized recruiting agencies and offer fake employment opportunities to candidates. These scammers often seek to obtain personal information or money from candidates. Please note that Hewlett Packard Enterprise (HPE), its direct and indirect subsidiaries and affiliated companies, and its authorized recruitment agencies/vendors will never charge any candidate a registration fee, hiring fee, or any other fee in connection with its recruitment and hiring process. The credentials of any hiring agency that claims to be working with HPE for recruitment of talent should be verified by candidates and candidates shall be solely responsible to conduct such verification. Any candidate/individual who relies on the erroneous representations made by fraudulent employment agencies does so at their own risk, and HPE disclaims liability for any damages or claims that may result from any such communication.