Associate III Quality Control - Chemistry

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.

• 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.

• 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.

• Experience with FDA/EMA/HA and local regulatory compliance.
• Familiarity with small molecule testing science principles.
• Proficiency in generating purchase requisitions and processing invoices.