Quality Assurance Specialist - Cincinnati, OH

Siemens Healthineers AG; United States; Sur place; USD 89 000 - 123 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Résumé du poste

Siemens Healthineers AG in the United States is seeking a Quality Specialist to provide quality oversight for a PET radiopharmaceutical site. You will lead GMP investigations, CAPA, batch release, and audits, while supporting FDA inspections and mentoring staff.

The role requires 3–5 years of QA experience in regulated environments, a scientific degree, and the ability to travel 10–25%. You will contribute to continuous improvement and ensure regulatory compliance across quality metrics.

Qualifications

• Bachelor’s degree in a scientific field or equivalent experience.
• 3–5 years QA experience in a 21 CFR Part 211/212 regulated industry.
• Experience with GMP investigations, CAPA, change control, batch release and audits.
• Ability to train/mentor staff and support FDA inspections.
• Strong problem-solving and root cause analysis skills.
• Proficiency with MS Office; willingness to travel 10–25%.

Responsabilités

• Provide quality oversight of a US-based site manufacturing and distributing PET sterile injectables.
• Lead GMP investigations, CAPA, change management, batch release and batch record reviews; conduct site quality audits and data integrity audits.
• Offer on-site training/mentoring and host/support FDA inspections.
• Serve as SME on assigned topics and contribute to policies and procedures.
• Participate in continuous improvement projects and manage site quality metrics.
• Oversee form reviews, inventory management, and staff qualifications observations.

Connaissances

QA experience

GMP knowledge

Root cause analysis

Audits

Training & mentoring

MS Office

Travel readiness

Formation

Bachelor’s degree in a scientific field

Microbiology/Analytical Chemistry studies

Description du poste

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.

AtSiemens Healthineers, we operate the world’s largest PET radiopharmaceutical network — delivering over1 million doses annuallywith a>99% fulfillment rateand supporting more than 2,800 imaging centers worldwide.

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 ifyou 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 to travel 10% - 25%.
• Relevant QA experience for 3-5 years in a 21 CFR Part 211 or 212 regulated industry.

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

$89,220 - $122,672

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company’s plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement

Siemens Healthineers is an Equal Opportunity and Aff

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Reasonable Accommodations

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Export Control

"A successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations."

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