Quality Assurance Specialist – Cincinnati, OH
A Siemens Quality Assurance Job opportunity has emerged at Siemens Healthineers for a Quality Assurance Specialist in Cincinnati, OH. This full-time role invites professionals eager to contribute to advancements in healthcare while ensuring compliance with industry standards.
About the Company
Siemens Healthineers is a global leader in medical technology, operating the world’s largest PET radiopharmaceutical network. The organization is dedicated to delivering over 1 million doses annually, supporting more than 2,800 imaging centers worldwide. Siemens Healthineers is committed to pioneering breakthroughs in healthcare for everyone, everywhere, sustainably.
Job Details:
- Company: Siemens Healthineers
- Location: Cincinnati, OH
- Job Requisition ID: R-31038
- Job Type: Full-time
- Posted On: 12 October 2023
Siemens Quality Assurance Job Description
This Siemens Quality Assurance Job is well suited for an ambitious professional looking to advance their career. As a Quality Assurance Specialist, the individual will provide quality oversight for a US-based site that manufactures and distributes radioactive sterile injectables, ensuring compliance with 21 CFR Part 212 and USP 825.
Key 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.
- Focusing on GMP Investigations and CAPA’s, change management, batch release, and batch record reviews, site Quality audits, and data integrity audits.
- Providing on-site support for training/mentoring, performing internal and third-party quality audits, and hosting FDA inspections.
- Serving as the subject matter expert on assigned topics, providing input on policies, procedures, and decisions related to those topics.
- Participating in continuous improvement projects.
- Managing quality metrics at the site, including focusing on reducing batch record corrections and investigations.
- Additional responsibilities include internal form review, inventory management, and observations of staff qualifications.
Quality Assurance Specialist Eligibility Criteria
- Experience in the pharmaceutical industry, preferably in sterile drug manufacturing and/or PET radiopharmaceuticals.
- Ability to interpret regulatory policies and guidance documents accurately.
- Expertise in quality assurance disciplines, including problem-solving root cause analysis, and management of corrective actions.
- Completion of studies in Microbiology and/or Analytical Chemistry.
- Flexibility to travel.
Required Skills
- Bachelor’s degree in a scientific field (biology, chemistry, microbiology, pharmacy, etc.) or equivalent experience.
- Excellent attention to detail.
- Creative problem-solving skills with the ability to manage multiple priorities.
- Relevant QA experience of 3-5 years in a regulated industry.
- Proficiency in MS Office software (Word, PowerPoint, Excel, and Outlook).
Salary
The base pay range for this position is $89,220 – $122,672. Factors affecting starting pay may include geography/market, skills, education, experience, and other qualifications.
How to Apply
Interested candidates are encouraged to apply through the following link:
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Siemens Healthineers offers a compelling opportunity for qualified candidates to make a significant impact in the healthcare sector. Those considering this Siemens Quality Assurance Job are encouraged to apply before the deadline to be part of a team that is dedicated to pioneering breakthroughs in healthcare. As this listing was posted on 12 October 2023, candidates should verify the role’s current availability on the official Siemens Healthineers careers site.
