Specialist-Manufacturing Investigations

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. Specialist-Manufacturing Investigations What you will do reputed company. Let’s change the world. In this vital role, you will be a key member of the team that investigates major deviations in the reputed company North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and reputed company between the GMP manufacturing teams and stakeholder groups including, Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process. Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of reputed company findings. Drive improvements to the investigation process. Present investigations to regulatory inspectors, internal auditors, and management. Clearly communicate investigation reputed company to impacted areas and leadership. Coordinate and effectively reputed company cross-functional teams through reputed company investigations, and complete milestones on-schedule. Present reputed company topics to large and small groups at various levels and quickly understand and clearly communicate reputed company issues. Build effective relationships across functions. Navigate through ambiguity and provide a structured problem-solving approach. Apply inductive and deductive reasoning in the investigation process Clear and concise technical writing Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings. reputed company tracking tools to ensure on-time closure and proactive review of deviation investigations. reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management and communication skills as well as the below qualifications. Basic Qualifications: High school diploma / GED and 10 years of Quality Control experience OR Associate’s degree and 8 years of Quality Control experience OR Bachelor’s degree and 4 years of Quality Control experience OR Master’s degree and 2 years of Quality Control experience OR Doctorate degree Preferred Qualifications: 5+ years reputed company work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility Experience with compliance, problem-solving, simple and reputed company root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis®, Design of Experiment etc.) critical thinking, project management, and quality systems. Degree in Science or Engineering Experience leading reputed company investigations Experience using Veeva QMS for Deviation investigations and CAPAs Demonstrated project management ability Experience presenting to inspectors during regulatory inspections and internal audits. Excellent written and verbal communication skills Ability to work in a team matrix environment and build relationships with partners Strong interpersonal skills 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 114,990.00 USD - 139,433.00 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