Quality Assurance Specialist

Siemens Healthineers AG; Loma Linda (CA); Sur place; USD 101 000 - 139 000; Plein temps

Résumé du poste

Siemens Healthineers seeks a Quality Specialist to oversee quality at a US site manufacturing radioactive sterile injectables. You will manage GMP investigations, CAPA, batch release reviews, and audits while ensuring data integrity and regulatory compliance.

On-site training and support for FDA inspections are integral to the role. You will work with a team focused on continuous improvement, risk mitigation, and policy input, traveling as needed to support Quality oversight across Radiopharma

Qualifications

• Experience in GMP/regulated pharma environments, including 21 CFR Parts 211/212 or USP 825.
• Ability to lead investigations, write comprehensive CAPA plans and close-out.
• Familiarity with data integrity concepts and audits.
• Strong attention to detail and problem-solving skills.

Responsabilités

• Provide Quality oversight of a US-based site manufacturing and distributing radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825.
• Focus on GMP investigations, CAPAs, change management, batch release and batch record reviews.
• Conduct site quality audits and data integrity audits to support Radiopharma’s oversight.
• Provide on-site training and mentoring, perform internal and third-party audits, and host FDA inspections.
• Serve as SME on topics and contribute to policies and decisions.
• Manage quality metrics, targeting reduction of corrections, investigations, and failed batches.

Connaissances

Quality oversight

CAPA & investigations

GMP compliance

Audits & inspections

Root cause analysis

MS Office

Formation

Bachelor’s degree in a scientific field

Outils

MS Office

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.

Responsibilities

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 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.

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.

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 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.

EEO is the Law:

Applicants and employees are protected under Federal law from discrimination.

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,

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California residents have the right to receive additional notices about their personal information.

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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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.

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