Quality Assurance Specialist

Siemens Healthcare; United States; Vor Ort; USD 101.000 - 139.000; Vollzeit

Benefits dieser Stelle

Medical insurance

401(k) retirement plan

Paid time off

Dental insurance

Zusammenfassung

Siemens Healthineers is hiring a Quality Specialist to oversee the US site manufacturing and distribution of radioactive sterile injectables (PET) in compliance with 21 CFR Part 212 and USP 825. You will drive GMP investigations, CAPA, batch release, and audits while mentoring staff and supporting FDA inspections.

You will also analyze quality metrics, manage internal form reviews, inventory, and site qualifications, contributing to continuous improvement across Radiopharma operations.

Qualifikationen

• Bachelor's degree in a scientific field preferred or equivalent experience.
• Excellent attention to detail and problem-solving skills.
• Experience in QA within a regulated environment (21 CFR Part 211/212, Part 11).
• Willingness to travel 10–25%.
• Strong ability to interpret regulatory guidance and apply it to activities.

Aufgaben

• Provide quality oversight for a US-based site manufacturing and distributing radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825.
• Lead GMP investigations and CAPA process, change management, batch release and batch record reviews.
• Support site quality audits, data integrity audits, and FDA inspections on-site.
• Serve as SME on policies and procedures related to assigned topics; participate in continuous improvement projects.
• Monitor quality metrics and drive reductions in batch record corrections and failed batches.

Kenntnisse

Attention to detail

Creative problem solving

Regulatory interpretation

Travel readiness

Quality investigations

Ausbildung

Bachelor's degree in science

Microbiology or Analytical Chemistry study

Tools

MS Office (Word, PowerPoint, Excel, Outlook)

Jobbeschreibung

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.

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 hosting/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

• 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

$101,030 - $138,919

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.

Benefits

• 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 affirm... encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard t