Pharmacy Quality Specialist (Jacksonville, FL)

Now's our time to inspire the future ofhealthcare together.

SiemensHealthineers' PETNET Solutions, a global PET radiopharmaceutical network, leadsthe way in industry expertise. Providing routine, reliable delivery ofhigh-quality radiopharmaceuticals and services has established us as thetrusted partner in PET imaging since 1996.

Withmore than 47 locations around the globe, Siemens Healthineers PETNET Solutionsis the largest supplier of positron emission tomography (PET)radiopharmaceuticals, delivering more than 1,000,000 doses to more than 2,800imaging centers worldwide, each year. Since 1996 we have delivered morethan 6,000,000 doses worldwide.

Becausewe 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 orderwith us, we are successful at dispensing the dose. That is confidencedelivered. 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 bonusplan, 100% matching 401K, 20 days of paid time off (vacation, sick and personaltime) per year as well as and 5 floating holidays!

Joinour team now at Siemens Healthineers as a Quality Specialist

Thisis a role well suited to an ambitious professional, looking for the next stepin their career. As a Quality Specialist, youwill 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.

Thisposition may suit you best if you are familiar with what isbelow, and would liketo 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%

AtSiemens Healthineers, we value those who dedicate their energy and passion to agreater cause. Our people make us unique as an employer in the med-techindustry. What unites and motivates our global team is the inspiration of ourcommon purpose: To innovate forhealthcare, building on our remarkable legacy of pioneering ideas thattranslate into even better healthcare products and services. We recognize thattaking ownership of our work allows both us and the company to grow. We offeryou a flexible and dynamic environment and the space to move beyond yourcomfort zone to grow both personally and professionally.

Ifyou want to join us in transforming the way healthcare is delivered, visit ourcareer site at https://usa.healthcare.siemens.com/careers.

Ifyou wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

As anequal-opportunity employer we are happy to consider applications from individualswith disabilities.

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PETNET

Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

Experience Level: Mid-level Professional

Full / Part time: Full-time

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