Quality Assurance Specialist

Siemens Medical Solutions USA, Inc.; United States; On-site; USD 92,000 - 126,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term and short-term disability

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers USA seeks a Corporate Quality Specialist based in Knoxville, TN. You will provide quality oversight for the Production Support Lab, Technical Support Team, and Implementation Team supporting US radiopharma sites, ensuring compliance with 21 CFR Part 212 and USP 825.

The role emphasizes quality system stewardship, root cause and trend analysis, investigations, CAPA management, and cross-functional training. Travel up to 10% may be required for audits and projects.

Qualifications

• Experience in the pharmaceutical industry and radiopharma per 21 CFR Part 212 and Part 11 and/or USP 825.
• At least 3 years of radiopharmaceutical manufacturing experience and 3 years of QC testing for radiopharmaceuticals.
• Quality assurance disciplines: problem-solving, root cause analysis, investigation writing, and CAPA management.
• Identify procedural gaps and product risk and propose contingency plans to mitigate compliance.
• Coordinate between departments to ensure tasks are on track and compliant.
• Studies in Microbiology and/or Analytical Chemistry or related technical field.
• Proactive schedule management to complete responsibilities on time.
• Willing to travel 10%.

Responsibilities

• Provide Quality oversight of Production Support Lab, Technical Support Team, and Implementation Team for US radiopharma sites per 21 CFR Part 212 and USP 825.
• Act as the Quality System Officer (QSO) for the listed corporate teams.
• Assist Corporate Quality with root cause analysis and trend analysis to support GMP investigations and CAPAs.
• Review GMP-related investigations, CAPAs, change controls for technical accuracy.
• Serve as SME on assigned topics, contributing to policies and decisions.
• Participate in continuous improvement and trend analysis projects.
• Review qualifications and documentation, provide GMP training, and support audits and inspections.
• This role is based in Knoxville, TN and is not remote.

Skills

Quality oversight

Root cause analysis

GMP investigations

CAPA management

Cross-functional coordination

MS Office

Travel willing

Education

Bachelor’s degree in science

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 Specialist

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 and18,000 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 servicesin 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. As a Corporate Quality Specialist, you will be responsible for :

• 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.

Qualifications

• 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%

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. (use your country EEO required language where applicable)

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.

The base pay range for this position is:

$91,850 - $126,291

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... All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here .

Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

California Privacy Notice: California residents have the right to receive additional notices about their personal information. To learn more, click here .

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.”

Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you’re concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.