Quality Assurance Specialist

Siemens Healthineers

19h•Onsite

About The Position

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.

Requirements

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.
Ability to work with controlled technology in accordance with US export control law.

Nice To Haves

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.
Completed studies in Microbiology and/or Analytical Chemistry.
Experience with MS Office software (Word, PowerPoint, Excel and Outlook).
Flexibility to travel.

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.
Internal form review.
Inventory management.
Observations of staff qualifications and facility inspection.