Sr Associate I, Quality Control

at  Biogen

Job Description

QUALIFICATIONS

• Pharmacy, Chemistry or Biological Science degree.
• English (intermediate to advanced level - spoken and written)
• Minimum of 5 years of experience in Quality Control.
• Distinguished experience with chemistry testing is mandatory.
• Experience in pharmaceutical companies (human health) is required.
• Based in Villa Soldati CABA, Buenos Aires - Argentina
  Additional Information

You, as our Senior Associate I - Quality Control, will be responsible for contributing to tactical and operational aspects of the Quality Control group at the Biogen Laboratory in Villa Soldati CABA, Buenos Aires, Argentina. Will also be accountable for, but not limited to:

• Performing QC routine testing, and all activities associated with executing this testing in a cGMP manner (Routine microbiological and/or physico-chemical testing of finished product for commercial release).
• Ensuring adherence to all regulatory licenses and regulations, serving as a subject matter expert in multiple disciplines, interfacing with key Quality Assurance and Global Quality Control, Supply Chain, Regulatory Affairs and coordination of investigations impacting Quality areas.
• Providing technical support as a subject matter expert during internal and external inspections.
• Coaching and continuous improvement for all Quality Systems cross-functionally.
• Authors or reviews controlled documents, investigational protocols, investigational reports, change control requests, validation protocols, validation reports, exception reports according to applicable procedures.
• Leads the execution of method transfer, method development, method qualification, analytical improvement projects and validation of analytical methods in collaboration with the Analytical Technology/Development group.
• Supporting the management team to ensure that laboratory and Quality systems within the department remain in compliance with Biogen and industry standards.