Collegeville, Pennsylvania, USA
5 days ago
Quality Engineer II
As part of GSK’s ambition to “Supercharge our data capability”, the Onyx Research Data Platform organization represents a major investment by GSK R&D and Digital & Tech, designed to deliver a step-change in our ability to leverage data, knowledge, and prediction to find new medicines. We are a full-stack shop consisting of product and portfolio leadership, data engineering, infrastructure and DevOps, data / metadata / knowledge platforms, and AI/ML and analysis platforms, all geared toward: Building a next-generation, metadata- and automation-driven data experience for GSK’s scientists, engineers, and decision-makers, increasing productivity and reducing time spent on “data mechanics” Providing best-in-class AI/ML and data analysis environments to accelerate our predictive capabilities and attract top-tier talent Aggressively engineering our data at scale, as one unified asset, to unlock the value of our unique collection of data and predictions in real-time We are looking for a high performing and enthusiastic Quality Engineer who will work with stakeholders to drive the Onyx Quality agenda forward at pace. This is a key role in the Onyx Quality team that will work closely with the Director of Quality and the Senior Quality Manager to continue embedding the right quality culture in Onyx. Key responsibilities for the Quality Engineer include: Quality Framework Compliance: Partner with Onyx team members to facilitate documentation of Onyx-specific processes (focusing on the ‘how’) that aligns with the requirements of the ITMS and Onyx Quality Framework. Monitor deliverable quality, ensure quality standards are being met for products/ projects, programs or operations within their remit, following a risk based approach. Provide quality support and oversight during application development and maintenance Monitoring and analysis of different quality issues, incidents and risks. Support Internal / External audits – including Audit Readiness activities Support the authoring, implementation and maintenance of QMS operational processes and governance that are fit for purpose for Onyx, and that are aligned with GSK’s wider quality ecosystem. Support effective embedding of QMS process into Onyx’s engineering ways of working that fits modern agile software engineering practice, including supporting users in the implementation of the Onyx Quality framework. Build strong relationships with stakeholders within and outside of Onyx to allow for effective implementation of Onyx processes and activities to help embed the right quality culture. Initiate and fulfil administrative tasks such as but not limited to, maintenance of logs, coordinating training, authoring Quality documents, keeping Quality tasks updated. Risk Management Contribute administration of Risk management activities in Onyx Facilitate risk identification and risk discussions within the business unit, both operational risk and product/project risks as required. Enforce compliance within policies and procedures as required within Onyx Audit and Training Support Contribute to ensuring Onyx is ready to host external and internal auditors as required. Maintain and monitor a continuous training and education program to ensure ongoing awareness on new and updated Policies and Standards within Onyx. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree in Data Management, Biological science, Information security, Engineering or related fields. 3+ years of experience of working with Quality systems and/or in Quality Assurance Experience with MS tools and other electronic systems. Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong written and verbal communication capabilities, technical writing ability and concise language skills. Proven ability to review and assess technical information ensuring delivery of user focused, fit-for-purpose, simple content Team player with demonstrated ability to motivate and work collaboratively with a team of expert staff to deliver consistently high standards. Working knowledge of different electronic systems and tools such as Jira, Confluence is highly desirable. #GSKOnyx #LI-GSK #GSKTech1 Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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