Associate III Quality Control

1 semana atrás

Buenos Aires, Brasil Biogen Tempo inteiro
Associate III Quality Control - Chemistry

Join to apply for the Associate III Quality Control - Chemistry role at Biogen

Associate III Quality Control - Chemistry

Join to apply for the Associate III Quality Control - Chemistry role at Biogen

About This Role
As an Associate III in the Quality Control group at our Biogen Laboratory in

About This Role
As an Associate III in the Quality Control group at our Biogen Laboratory in Villa Soldati, CABA ; you will be an integral member of the Quality Control team, contributing to key functional, tactical, and operational elements. Your primary focus will be on performing QC environmental, routine physico-chemical, and microbiological testing of products to support their release and distribution in Argentina. This involves tasks such as pH measurement, appearance checks, osmolality assessments, moisture analysis (Karl-Fisher), HPLC, dissolution tests, UV identification, microbial limit tests , and other related activities adhering to cGMP and local Health Authority requirements. You will manage projects, facilitate method transfers, and oversee qualification and validation activities. Your role will ensure the maintenance of laboratory equipment and supplies, review GXP documentation, and foster leadership competencies while aiding in the development of your peers. Moreover, you will serve as a subject matter expert, ensure compliance with regulatory licenses, interface with key stakeholders in Quality Assurance, Manufacturing, and Quality Control, and coordinate investigations impacting Quality areas. Your expertise will also support Quality Management in interviewing, training employees, and driving compliance with training policies. This position requires excellent written and verbal communication skills in English and a mature leadership approach to effectively manage personal communication styles within the team framework.
What You’ll Do

  • Perform routine release testing of finished products, including physico-chemical analyses such as pH, appearance, osmolality, moisture (Karl-Fisher), assay and impurities by HPLC, uniformity content, dissolution tests, and UV identification.
  • Participate in and manage the execution of method transfers and analytical improvement projects.
  • Provide timely review of data and documentation generated for or by Quality Control.
  • Author or review controlled documents, investigational protocols, investigational reports, and change control requests.
  • Support laboratory stock management for the QC lab, ensuring the availability of laboratory reference materials.
Who You Are
You possess a strong understanding of quality control testing principles and are naturally curious, eager to learn, and ask questions to seek evidence-based clarity. You excel in communication and collaboration, demonstrating logical thinking and the ability to work across all organizational levels effectively.
Required Skills
  • 2 years of relevant experience in Quality Control or related field.
  • Studies in Pharmacy, Chemistry, or Biological Sciences.
  • Proficiency in microbiological and physico-chemical testing methodologies.
  • Strong organizational skills and ability to multi-task and manage multiple projects.
  • Advanced English. Fluency Preferred.
Preferred Skills
  • Experience with FDA/EMA/HA and local regulatory compliance.
  • Familiarity with small molecule testing science principles.
  • Proficiency in generating purchase requisitions and processing invoices.
#Villa Soldati
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 Entry level
Employment type
  • Employment type Full-time
Job function
  • Job function Quality Assurance

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