Quality Assurance Specialist

Siemens Healthcare; Cranston (RI); On-site; USD 95,000 - 120,000; Full time

Job summary

Siemens Healthineers is seeking a Corporate Quality Assurance Specialist based in the United States. The role focuses on QA oversight for Radiopharma-related labs and teams, serving as the Quality System Officer and driving GMP investigations, CAPA, and change controls.

The ideal candidate has a scientific background and at least 3 years in radiopharmaceutical QA, with strong problem-solving and cross-functional collaboration skills.

Qualifications

• Bachelor's degree in a scientific field is preferred or equivalent experience.
• 3+ years of experience manufacturing radiopharmaceuticals.
• Experience in QA disciplines: problem-solving, root cause analysis, investigations and CAPA.
• Willing to travel 10%.

Responsibilities

• Provide Quality oversight of the Production Support Lab, Technical Support Team and Implementation Team.
• Act as the Quality System Officer (QSO) for the listed corporate teams.
• Assist GMP investigations, CAPA reviews, change controls and related documentation.
• Serve as SME on assigned topics, advising policies, procedures and decisions.
• Support audits and inspections to uphold Radiopharma QA oversight.

Skills

Quality oversight

Root cause analysis

CAPA management

GMP investigations

Training on GMP

Audits & inspections

MS Office

Radiopharma

Education

Bachelor's degree in a scientific field

Tools

MS Office

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Corporate Quality Assurance Specialist

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 a Corporate Quality Specialist.

This is a role well suited to an ambitious professional, looking for the next step in their career.

• You will provide Quality oversight of the Production Support Lab, the Technical Support Team and Implementation Team. These teams support US based sites that manufacture and distribute radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for Radiopharma.
• You will act as the Quality System Officer (QSO) for the listed corporate teams.
• You will assist the Corporate Quality group with root cause analysis and trend analysis of technical issues as needed (analytical equipment and manufacturing-related) to support GMP investigations and CAPA's.
• You will review GMP-related investigations, CAPA's, change controls, etc. as assigned to ensure any technical components are accurate.
• You will serve as the subject matter expert on assigned topics providing input on policies, procedures and decisions related to those topics.
• You will participate in continuous improvement and trend analysis projects as assigned.
• Additional responsibilities include review of qualifications and other documentation, providing GMP training to corporate personnel as needed, and supporting audits and inspections as needed to support Radiopharma's Quality oversight functions.

This is not a remote position; this position will be based in Knoxville, TN.

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 at least 3 years of experience manufacturing radiopharmaceuticals and at least 3 years of experience performing QC testing of radiopharmaceuticals.
• You are experienced 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 can coordinate between different departments to ensure that tasks are on track and compliance is maintained.
• You have completed studies in Microbiology and/or Analytical Chemistry or a similar technical discipline.
• You can proactively manage your schedule to ensure all assigned responsibilities are completed accurately and on schedule.
• 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. Can manage your own schedule efficiently to ensure all job responsibilities are completed on-time and with a high degree of excellence.
• 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%

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.