Quality Specialist - On-site

Do you wantto join us in helping to fight the world’s most threatening diseases andenabling access to care for more people around the world?

At SiemensHealthineers, we pioneer breakthroughs in healthcare.For everyone. Everywhere.

At SiemensHealthineers, We offer you a flexible and dynamic environment withopportunities to go beyond your comfort zone in order to grow personally andprofessionally.

Sound interesting? Then come and join our global team as a QualitySpecialist.

Our globalteam : We are a team of more than 68,000 highly dedicatedemployees across more than 70 countries passionately pushing the boundaries ofwhat’s possible in healthcare to help improve people’s lives around the world.

As a leader in the industry, we aspire to create better outcomes and experiencesfor patients no matter where they live or what health issues they are facing.

Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guidedtherapy and innovative cancer care, is crucial for clinical decision-making andtreatment pathways.

This is a role well suited to anambitious professional, looking for the next step in their career. As a QualitySpecialist, you will be responsible for :

• You will provide Quality oversight of a US based site that manufactures and distributes radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for PETNET Solutions.
• In your activities, you will focus on GMP Investigations and CAPA’s, change management, batch release and batch record reviews, site Quality audits and data integrity audits to support PETNET’s Quality oversight functions.
• You will provide on-site support for the purposes of training / mentoring, performing internal and 3rd party quality audits and to host / support FDA inspections.
• You will serve as the subject matter expert on assigned topics providing input on policies, procedures and decisions related to those topics.
• You may participate in continuous improvement projects.
• You will 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 positionmay suit you best if you are familiar with what is below,and would like to dodevelop 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 experience in interpreting regulatory policies and guidance documents and can correctly apply them as appropriate to related activities.
• You are an expert 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 have completed studies in Microbiology and / or Analytical Chemistry
• 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
• 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%

At SiemensHealthineers, we value those who dedicate their energy and passion to a greatercause. Our people make us unique as an employer in the med-tech industry.

Whatunites and motivates our global team is the inspiration of our common purpose : To innovate for healthcare, building on ourremarkable legacy of pioneering ideas that translate into even betterhealthcare products and services.

We recognize that taking ownership of ourwork allows both us and the company to grow. We offer you a flexible anddynamic environment and the space to move beyond your comfort zone to grow bothpersonally and professionally.

Beware of JobScams

Successful candidate must beable to work with controlled technology in accordance with US export controllaw. It is Siemens Healthineers’ policy to comply fully and completely withall United States export control laws and regulations, including thoseimplemented by the Department of Commerce through the Export AdministrationRegulations (EAR), by the Department of State through the International Trafficin Arms Regulations (ITAR), and by the Treasury Department through the Officeof Foreign Assets Control (OFAC) sanctions regulations.

As anequal-opportunity employer we are happy to consider applications fromindividuals with disabilities.

LI-JW1

PETNET

Equal Employment Opportunity Statement

Siemens is an Equal Opportunity and Affirmative 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 status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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 by clicking on this link If you’re unable to complete the form, you can reach out to our AskHR team for support at 1-866-743-6367.

Please note our AskHR representatives do not have visibility of application or interview status.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more, .

Pay Transparency Non-Discrimination Provision

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, .

California Privacy Notice

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