Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as Senior Quality Specialist (Microbiology Professional)
This is a role well suited to an ambitious
professional, looking for the next step in their career. As a Senior Quality Specialist (Microbiology
Professional), you will be
- You will serve as a subject matter expert for the PETNET Sterility Assurance and Environmental Monitoring programs
- Monitor environmental monitoring data from assigned PETNET sites and propose action items to identified trends
- Review, approve, and facilitate environmental monitoring investigations from assigned PETNET sites
- You will serve as a leader on the Sterility Assurance Team
- Serve as a primary investigator and reviewer of sterility investigations
- Evaluate and approve proposed SOP changes and validation protocols/reports related to sterility assurance and environmental monitoring
- You will lead continuous improvement projects as assigned
- Perform/support internal audits as assigned
- Assist with supplier audits for sterile material suppliers and microbiological laboratories as assigned
- Support regulatory inspections as needed
- Other quality/regulatory related duties as assigned/needed
This position may suit you best if you are familiar
with what is below, and would like to do develop your career with
- You are a microbiologist experienced in and focused on environmental monitoring and sterility assurance in the pharmaceutical industry (21 CFR Part 211) and/or PET radiopharmaceuticals industry (21 CFR Part 212)
- Experienced in the review and analysis of microbiological data
- Experience with regulatory (FDA, Boards of Pharmacy, etc.) and third party audits
- Experienced in developing and implementing remediation strategies as well as new processes/procedures
- You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
- Ability to interpret Regulatory policies and guidance documents and correctly apply them as appropriate to related activities
- You can identify procedural gaps and product risk and where appropriate, recommend contingency plans and strategies to mitigate compliance risks
- Willingness to travel and flexibility is expected
- You are organized and an excellent communicator
Required skills to have for the success of this role
- Bachelor of Science degree in Microbiology/Biology or equivalent experience
- Master of Science degree in Microbiology/Biology is preferred
- Minimum of 5-8 years of Microbiology related experience; preferably in a pharmaceutical related industry
- Willing to travel up to 40%
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date.
(Note: Accommodations may be requested for certain medical or religious reasons)
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for all new hires by their start date. (Note: Accommodations may be requested for certain medical or religious reasons).
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.
Organization: Siemens Healthineers
Company: PETNET Solutions, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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