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Associate III, Quality Control
4 semanas atrás
Join to apply for the Associate III, Quality Control - Microbiology role at Biogen
Associate III, Quality Control - MicrobiologyJoin to apply for the Associate III, Quality Control - Microbiology role at Biogen
About This Role
As an Associate III, Quality Control at our laboratory in
Villa Soldati CABA,
you will play a pivotal role in the Quality Control group. You will be responsible for conducting essential environmental, physico-chemical, and microbiological testing to support the release and distribution of products in Argentina. Your role will include
About This Role
As an Associate III, Quality Control at our laboratory in Villa Soldati CABA,
you will play a pivotal role in the Quality Control group. You will be responsible for conducting essential environmental, physico-chemical, and microbiological testing to support the release and distribution of products in Argentina. Your role will include microbial limit tests, endotoxin, sterility, and more, ensuring compliance with cGMP and local Health Authority requirements. You'll manage projects related to method transfer, qualification, and validation activities, and maintain laboratory equipment and supplies. Your expertise will guide the review of GXP documentation while fostering the development of peers through leadership modeling. Additionally, your proficiency in Biogen Quality Systems will be key for continuous improvement across Quality Systems. You will be a subject matter expert, liaising with Quality Assurance, Manufacturing, and Quality Control teams, while coordinating investigations impacting the quality areas. This role requires a mature leadership approach, excellent English communication skills, and the ability to work independently and collaboratively across all business areas.
What You'll Do
- Perform routine release testing of finished products, including microbiological testing for product release and distribution in Argentina.
- Conduct QC environmental monitoring and microbial limit tests, ensuring compliance with cGMP and local Health Authority requirements.
- Participate in and manage method transfers and analytical improvement projects.
- Provide timely review of data and documentation generated for or by QC.
- Author or review controlled documents, investigational protocols, and reports.
- Manage laboratory stock and ensure the availability of laboratory reference materials.
You are inquisitive and eager to learn, always questioning and seeking evidence to support your findings. Your strong understanding of quality control testing principles, combined with excellent communication and collaboration skills, enables you to work effectively across all levels of the organization. Logical thinking is your forte, making you a valuable team member who excels in both independent and collaborative settings.
Required Skills
- 2 years of relevant experience in Quality Control or related field.
- Studies in Pharmacy, Chemistry, or Biological Sciences.
- Proficiency in microbiological testing methodologies.
- Strong organizational skills and ability to multi-task and manage multiple projects.
- Advanced English. Fluency preferrred.
- Experience with FDA/EMA/HA and local regulatory compliance.
- Familiarity with small molecule testing science principles.
- Proficiency in generating purchase requisitions and processing invoices.
Job Level: Professional
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. Seniority level
- Seniority level Mid-Senior level
- Employment type Full-time
- Job function Quality Assurance
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