Posted in Information Technology about 9 hours ago.
Type: Full Time
Job Description
About This Role:
As the QC Site EM/UM and Contamination Specialist, you will be an integral member of our Quality Control operations team at RTP Pharma. Your expertise will be pivotal in managing and enhancing the Environmental Monitoring (EM) and Utility Monitoring (UM) programs at our site. You'll take on the mantle of a microbiology subject matter expert during manufacturing contamination events, ensuring that our products meet the highest quality standards. Your role involves periodic reporting on EM/UM data trends and spearheading remediation and improvement actions. By leading the Environmental Review Board, you maintain a comprehensive sampling schedule and scrutinize results for significant trends, contributing to our site's exemplary regulatory compliance. In this position, you will act as a vital link between the site Quality Leader and the Site Leadership Team, escalating any contamination quality concerns. In essence, you are the guardian of our site's sterility assurance, fitting seamlessly into our business structure and adding tremendous value through your critical contributions to product integrity and safety.
What You'll Do:
Who You Are:
You are a dedicated professional with a deep understanding of bioburden, endotoxin, and identity testing. Your knowledge of Annex 1 and site contamination control strategies is robust, and you contribute actively to complex projects and initiatives. In your career, you have honed your leadership skills and developed a keen technical understanding of contamination response from a compliance perspective. You stay current with technological and compliance developments in the industry. You are someone who values open communication, teamwork, and the importance of a strong quality culture in the workplace.
Qualifications
Required:
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
PDN-9dc64f6e-81c4-4136-9fc4-5597b8cda4c2
Biogen |
Biogen |
Biogen |
Medline Industries, Inc. |
Medline Industries, Inc. |
Medline Industries, Inc. |