Quality Assurance Specialist - Cincinnati, OH

Siemens Healthineers AG; Au; On-site; INR 900,000 - 1,600,000; Full time

Job summary

Siemens Healthineers AG seeks a Quality Specialist to oversee quality for a US-based PET radiopharmaceutical site, ensuring compliance with 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPAs, batch release reviews, site audits, and data integrity audits, while mentoring staff and supporting FDA inspections.

Strong regulatory interpretation, problem-solving abilities, and travel readiness are essential to succeed in this role within our Radiopharma Quality team.

Qualifications

• Excellent attention to detail.
• Creative problem solving and ability to reprioritize quickly.
• Willing to travel as required.

Responsibilities

• Provide Quality oversight for a US-based site manufacturing radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825.
• Focus on GMP investigations and CAPAs, change management, batch release and batch record reviews.
• Conduct site quality audits and data integrity audits to support Radiopharma's quality oversight functions.
• Provide on-site support for training/mentoring, conducting internal and third-party audits, and supporting FDA inspections.
• Act as SME on assigned topics, contributing to policies, procedures and decisions.
• Participate in continuous improvement projects.
• Manage quality metrics at the site, including batch record corrections, investigations, and failed batches.

Skills

Attention to detail

Creative problem solving

Willing to travel

Education

Bachelor’s in science

Microbiology/Analytical Chemistry studies

Tools

MS Office (Word, PowerPoint, Excel, Outlook)

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.

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.

Join the global leader shaping the future of PET imaging.

At Siemens Healthineers, we operate the world’s largest PET radiopharmaceutical network — delivering over 1 million doses annually with a >99% fulfillment rate and supporting more than 2,800 imaging centers worldwide.

Responsibilities

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:

• Providing Quality oversight of a US based site that manufactures and distributes radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for Siemens Healthineers - Radiopharma.
• Focusing on GMP Investigations and CAPA’s, change management, batch release and batch record reviews, site Quality audits and data integrity audits to support Radiopharma's Quality oversight functions.
• Provide on-site support for the purposes of training/mentoring, performing internal and 3rd party quality audits and to host/support FDA inspections.
• Serve as the subject matter expert on assigned topics providing input on policies, procedures and decisions related to those topics.
• Participate in continuous improvement projects.
• 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.

• 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.
• Experience in interpreting regulatory policies and guidance documents and can correctly apply them as appropriate to related activities.
• Are an expert in the quality assurance disciplines of problem-solving root cause analysis, investigation writing, and management of corrective and preventive actions.
• 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
• Experience with MS Office software (Word, PowerPoint, Excel and Outlook)
• Flexibility to travel.

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