Now’s our time to inspire the future of healthcare together. Siemens Healthineers’ PETNET Solutions, a global PET radiopharmaceutical network, leads the way in industry expertise. Providing routine, reliable delivery of high-quality radiopharmaceuticals and services has established us as the trusted partner in PET imaging since 1996. With more than 47 locations around the globe, Siemens Healthineers PETNET Solutions is the largest supplier of positron emission tomography (PET) radiopharmaceuticals, delivering more than 1,000,000 doses to more than 2,800 imaging centers worldwide, each year. Since 1996 we have delivered more than 6,000,000 doses worldwide. Because we have the largest network of pharmacies, our pharmacies back each other up. This gives us a dose fulfillment rate of >99%. If you place an order with us, we are successful at dispensing the dose. That is confidence delivered. Check us out: https://www.siemens-healthineers.com/en-us/molecular-imaging/petnet Benefits for full time employees include medical, dental and vision insurance, 8% annual bonus plan, 100% matching 401K, 20 days of paid time off (vacation, sick and personal time) per year as well as and 5 floating holidays! Join our team now at Siemens Healthineers as a Quality Specialist This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Specialist, you will be responsible for: You will provide Quality oversight of a US based site that manufactures and distributes radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for PETNET Solutions. In your activities, you will focus on GMP Investigations and CAPA’s, change management, batch release and batch record reviews, site Quality audits and data integrity audits to support PETNET’s Quality oversight functions. You will provide on-site support for the purposes of training/mentoring, performing internal and 3rd party quality audits and to host/support FDA inspections. You will serve as the subject matter expert on assigned topics providing input on policies, procedures and decisions related to those topics. You may participate in continuous improvement projects. You will manage quality metrics at the site, including focusing on reduction of batch record corrections, investigations, failed batches due to operator error and other quality metrics as assigned. Additional responsibilities include internal form review, inventory management, observations of staff qualifications and facility inspection. This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers You have experience in the pharmaceutical industry (preferably sterile drug manufacturing) and/or PET radiopharmaceuticals per 21 CFR Part 212 and Part 11 and/or USP 825 You have experience in interpreting regulatory policies and guidance documents and can correctly apply them as appropriate to related activities. You are an expert in the quality assurance disciplines of problem solving, root cause analysis, investigation writing, and management of corrective and preventive actions. You can identify procedural gaps and product risk and where appropriate, recommend contingency plans, and strategies to mitigate compliance You have completed studies in Microbiology and/or Analytical Chemistry You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook) You are willing to travel and be flexible Required skills to have for the success of this role Bachelor’s degree in a scientific field (i.e., biology, chemistry, microbiology, pharmacy, etc.) is preferred or equivalent experience required Excellent attention to detail Be a creative problem solver with the ability to reprioritize multiple times per day while working at the speed of business and delivering results on time. Willing to travel 10% - 25% At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally. If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers. If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about. As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. #LI-AW1 PETNET Organization: Siemens Healthineers Company: Siemens Medical Solutions USA, Inc. Experience Level: Mid-level Professional Full / Part time: Full-time Equal Employment Opportunity Statement Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law Applicants and employees are protected under Federal law from discrimination. To learn more, Click here. 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