Quality Assurance Specialist - Minneapolis, MN

Siemens Healthineers in; Minneapolis (MN); 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

Disability insurance

Parking or public transit benefits

Paid time off

Paid sick time

Job summary

Siemens Healthineers is seeking a Quality Specialist to oversee quality at a US-based radiopharma site producing radioactive sterile injectables. You will focus on GMP investigations, CAPA, batch release, and audits, while supporting staff training and FDA inspections.

You will apply root-cause analysis, identify gaps, and drive continuous improvement in quality metrics, with travel as needed. Strong regulatory experience in 21 CFR Parts 211/212 and USP 825 is valued.

Qualifications

• Bachelor’s degree in a scientific field is preferred or equivalent experience.
• Experience in interpreting regulatory policies and guidance documents.
• Root cause analysis, investigation writing, and CAPA management.
• Identify procedural gaps and mitigate compliance risks.
• Travel 10% - 25%.

Responsibilities

• Provide quality oversight of a US-based site manufacturing radiopharmaceuticals under 21 CFR Part 212 and USP 825.
• Lead GMP investigations, CAPA, change control, batch release, and batch record reviews.
• Conduct internal and external quality audits and data integrity audits; support FDA inspections.
• Serve as SME on policies and procedures; contribute to decisions on critical topics.
• Engage in continuous improvement projects and improve quality metrics.

Skills

Attention to detail

Problem solving

Prioritization

Travel readiness

Quality mindset

Education

Bachelor’s degree in a scientific field

Studies in Microbiology or Analytical Chemistry

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.

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 to host/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 ifyou 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:

$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 Affir... 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.

California Privacy Notice: 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.”

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.

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.