Quality Assurance Specialist - Minneapolis, MN

530d PETNET Solutions, 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

Disability insurance

Paid time off

Job summary

Siemens Healthineers seeks a QA professional to provide quality oversight for a US-based PET radiopharma site, ensuring compliance with 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPAs, batch release, and site audits while mentoring staff and supporting FDA inspections.

The role requires strong regulatory interpretation, problem-solving, and data integrity focus, with 10–25% travel. A science degree and 3–5 years QA experience in regulated pharma are essential.

Qualifications

• Pharma industry experience preferred; sterile drug manufacturing and/or PET radiopharmaceuticals per 21 CFR Part 212 and Part 11.
• Experience interpreting regulatory policies and guidance documents and applying them to activities.
• Expert in QA disciplines: root cause analysis, investigation writing, and corrective and preventive actions management.
• Identify procedural gaps and product risk and recommend contingency plans to mitigate compliance.
• Completed studies in Microbiology and/or Analytical Chemistry.

Responsibilities

• Provide quality oversight of a US-based site that manufactures and distributes radioactive sterile injectables (PET).
• Focus on GMP investigations and CAPAs, change management, batch release and batch record reviews, site quality audits and data integrity audits.
• Provide on-site support for training/mentoring, internal and third-party audits, and FDA inspections.
• Serve as subject matter expert on assigned topics and input on policies and procedures.
• Participate in continuous improvement projects.
• Manage quality metrics at the site, including reductions in batch record corrections, investigations, and failed batches.
• Oversee internal form reviews, inventory management, observations of staff qualifications and facility inspections.

Skills

Attention to detail

Problem solving

Creativity

Analytical thinking

Education

Bachelor’s degree in a scientific field

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.

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.

Role Responsibilities:

• 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.

Qualifications:

• 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.
• 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.
• Willing to travel 10% - 25%.
• Relevant QA experience for 3-5 years in a 21 CFR Part 211 or 212 regulated industry.

Required Skills:

• 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.

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.

Benefits:

• 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

Siemens Healthineers is an Equal Opportunity and Affiliation 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.

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.”

Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously.