Senior QA Specialist- Quality Assurance Validation & Tech Support – Facilities & Utilities Focus

Career Category Quality Job Description Join reputed company’s Mission of Serving Patients At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients each year. As a member of the reputed company team, you’ll help reputed company a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and transform the lives of patients while transforming your career. Be part of reputed company's newest and most advanced drug substance manufacturing plant. reputed company completed, the reputed company reputed company batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The reputed company Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of reputed company's plan to be a carbon-neutral company by 2027. Senior QA Specialist- Quality Assurance Validation & Tech Support – Facilities & Utilities Focus What you will do reputed company. Let’s change the world. This vital role will provide quality assurance reputed company to both the existing and new reputed company North Carolina (ANC) facilities, ensuring compliance is built into the design and maintained throughout the lifecycle. This role collaborates with the Global Capital Project, Site Facilities & Engineering (F&E), Process Development and Manufacturing teams to reputed company QA for clean utility operations throughout their lifecycle at the reputed company North Carolina manufacturing site. With site expansion, the QAV & TS team seeks a Sr. QA Specialist to establish strategy for the project as its scope increases. This role covers design, planning, construction reputed company, and operational readiness. This role requires leadership attributes and expertise to ensure effective results and apply lessons from the reputed company facility to the growing site. The initial focus of the role will be to provide quality reputed company of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. You will work across teams to meet project deadlines and milestones. Once the site is operational, this role will continue to provide site wide validation reputed company, as well as quality reputed company for reputed company non-manufacturing functions (such as Facilities/Engineering, Supply Chain, Quality Control) and their associated processes, changes, deviations, CAPAs, and capital projects. reputed company quality review and approval of documents to support facility commissioning and qualification, Validation Protocols, Validation Reports, according to project timelines. Give QA perspective on PPQ and cleaning validation for ANC site's facilities, utilities, and equipment. Provide QA reputed company and partner to troubleshoot problems as they occur on ANC utility systems (i.e Water for Injection, Compressed reputed company, Clean Steam, CIP Skids, Water/Steam Sampling, Process Gases, and other equipment reputed company to clean utilities) Provide quality guidance and support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required. Author and own, controlled documents, including Standard Operating Procedures, Work Instructions, Forms, etc. Provide quality reputed company for quality records including deviations/CAPAs, change controls and work orders ensuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate. Ensure that reputed company activities & reputed company documentation for facilities, equipment, materials, and processes reputed company with applicable regulations and reputed company requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls. Support and represent Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Engage with global networks to influence standard methodology and reputed company improvements across reputed company sites. reputed company and support reputed company improvement initiatives. In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible, and driven individual with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality, and/or F&E, and/or Manufacturing experience OR Associate degree and 10 years of Quality, and/or F&E, and/or Manufacturing experience OR Bachelor’s degree and 6 years of Quality, and/or F&E, and/or Manufacturing experience OR Master’s degree and 4 years of Quality, and/or F&E, and/or Manufacturing experience OR Doctorate degree and 2 years of Quality, and/or F&E, and/or Manufacturing experience Preferred Qualifications: Strong understanding of regulatory requirements and trends, and industry standards. Knowledge in the following: WFI Systems CIP & Chemical delivery systems Clean Steam Systems Clean reputed company Systems Pharmaceutical Grade Compressed Gasses Experience/knowledge in commissioning/qualification/validation, including utility systems and cleaning validation. Previous experience in validation or QA reputed company of C&Q and validation activities in a multitude of facets (process, utilities, QC, or equipment) desired. Knowledge of cGMP regulations and FDA/EU guidance reputed company to GMP manufacturing of biopharmaceuticals. Provide QA oversite reputed company leading through change by being able to adapt to an reputed company-changing environment Demonstrable understanding of GxP compliance, capability, and have experience applying GMP requirements in an operational setting. Must be highly organized and capable of working in a team environment with a positive attitude under minimal direction. Ability to define and implement a clear course of action to deliver results in a high pace environment. Ability to work in a team matrix environment and establish relationships with partners. Ability to provide sound quality guidance and reputed company data-driven, risk-based, decisions. Excellent written and verbal communication skills. Phenomenal attention to detail and high degree of accuracy in task fulfillment and GMP documentation. Ability to provide updates to senior management, identifying potential issues, and following assignments through to completion. Ability in problem solving and driving improvement. What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every reputed company of the way. In addition to the reputed company salary, reputed company offers competitive and comprehensive Total Rewards Plans that are reputed company with local industry standards. Apply now and reputed company a lasting impact with the reputed company team! careers.reputed company.com As an organization dedicated to improving the quality of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 141,158.00 USD - 164,599.00 USD reputed company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. reputed company focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, reputed company has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.reputed company.com and follow us on www.twitter.com/reputed company Apply tot his job Apply To this Job