Quality Assurance Specialist

Siemens Healthineers; Cincinnati (OH); On-site; USD 80,300 - 110,407; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers in Cincinnati, OH is seeking a Quality Assurance professional to oversee the quality of a site that manufactures radioactive sterile injectables. The ideal candidate will have a Bachelor's degree in a scientific field and 3-5 years of relevant QA experience in a regulated environment. Responsibilities include conducting GMP investigations, managing quality metrics, providing hands-on training and support for FDA inspections, and participating in continuous improvement projects. Benefits include medical insurance, retirement plans, and paid time off.

Qualifications

• 5+ years of relevant QA experience in a regulated industry.
• Experience with sterile drug manufacturing or PET radiopharmaceuticals.
• Ability to travel 10% – 25%.

Responsibilities

• Provide quality oversight for a site manufacturing sterile injectables.
• Focus on GMP investigations, CAPA's, and quality audits.
• Support FDA inspections and conduct internal audits.

Skills

Experience in the pharmaceutical industry

Regulatory policies interpretation

Problem-solving expertise

MS Office software proficiency

Creative problem solving

Education

Bachelor’s degree in a scientific field

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.

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 and mentoring, performing internal and third‑party quality audits and supporting 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 focus on reduction of batch record corrections, investigations, failed batches due to operator error and other quality metrics as assigned.
• Perform 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 interpreting regulatory policies and guidance documents and applying them appropriately.
• Expertise in the quality assurance disciplines of problem‑solving, root cause analysis, investigation writing and management of corrective and preventive actions.
• Ability to identify procedural gaps and product risk and recommend contingency plans and strategies to mitigate compliance issues.
• Completed studies in microbiology and/or analytical chemistry.
• Experience with MS Office software (Word, PowerPoint, Excel and Outlook).
• Flexibility to travel.

Required Skills

• Bachelor’s degree in a scientific field (biology, chemistry, microbiology, pharmacy, etc.) preferred or equivalent experience required.
• Excellent attention to detail.
• Creative problem solver capable of reprioritizing multiple times per day while working at the speed of business and delivering results on time.
• Willingness to travel 10% – 25%.
• Relevant QA experience for 3–5 years in a 21 CFR Part 211 or 212 regulated industry.

Pay Range

$80,300 – $110,407

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.

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affi­missive 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.