Quality Assurance Specialist

Regulatory Toolkit; Knoxville (TN); Vor Ort; USD 92.000 - 126.000; Vollzeit

Benefits dieser Stelle

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 time

Zusammenfassung

Siemens Healthineers in Knoxville, TN seeks a Corporate Quality Assurance Specialist to oversee quality across production support and implementation teams, serving as QSO for corporate radiopharma activities. The role requires GMP expertise, CAPA leadership, and strong analytical skills.

Experience in radiopharma/21 CFR Part 212, Part 11, and USP 825 is preferred. Travel up to 10% may be expected; base pay is shown below.

Qualifikationen

• Experience in pharmaceutical industry, preferably sterile drug manufacturing or PET radiopharmaceuticals.
• Minimum 3 years in radiopharmaceutical manufacturing and QC testing.
• Knowledge of GMP, CAPA, change controls, and investigations.
• Ability to identify procedural gaps and manage compliance risks.

Aufgaben

• Provide Quality oversight of Production Support Lab, Technical Support Team and Implementation Team.
• Act as Quality System Officer for corporate teams.
• Support GMP investigations and CAPA with root-cause and trend analysis.
• Review GMP investigations, CAPA, and change controls for accuracy.
• Provide GMP training and support audits and inspections.

Kenntnisse

Quality oversight

Root cause analysis

GMP investigations

QMS knowledge

MS Office

Ausbildung

Bachelor’s degree in a scientific field

Tools

MS Office

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.

Corporate Quality Assurance 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.

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.

This position may suit you best ifyou 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.

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 breaks through 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.

• 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 Affiantive Action Employer encouraging diversity in the workplace. 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 state, 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. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

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.”

Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.