Quality Assurance Specialist

Siemens Healthineers•San Saba, TX

17h•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 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. 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. 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. We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

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

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
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)

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