Quality Control Sr. Associate I
- Buenos Aires, Argentina
- Region: LATAM
At Biogen, our mission is clear: we are pioneers in neuroscience. Since our founding in 1978 as one of the world’s first global biotechnology companies, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.
The Sr. Associate I, Quality Control is responsible for contributing to key functional, tactical, and operational aspects of the Quality Control group. This includes performing QC routine testing and all activities associated with executing this testing in a cGMP manner (Routine physico-chemical and microbiological testing of finished product for commercial release). The Sr. Associate I responsibilities include, but are not limited to, project management, initiation of process improvements, liaison for method transfer, qualification and validation activities, modeling the leadership competencies and aiding in the development of peers.
A Sr. Associate I should be proficient in their understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality Systems cross-functionally. Additional responsibilities include 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, Supplay Chain, Regulatory Affairs and coordination of investigations impacting the Quality areas.
- Coordinates /performs testing and review for analytical data to support release of finished products (Routine Physico-chemical and Microbiological testing, Environmental monitoring and associated activities)
- Authors or reviews controlled documents, investigational protocols, investigational reports, change control requests, validation protocols, validation reports, exceptions reports according to applicable procedures. etc.
- Provides technical leadership through effective project management including laboratory investigations, technical problem solving with independence.
- Participates effectively in a leadership or membership role for site cross-functional teams as a representative of the QC laboratory.
- Proactively identifies technical gaps and areas for improvement related to quality or process and leads them through completion.
- 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.
- Manages Laboratory Stock for the QC lab to ensure business continuity
- Leads and Manages of Laboratory Validation Master Plan. Qualification, Calibration and preventive maintenance of laboratory analytical instrument and equipment.
- Self Training and training of peers (Biogen university and personnel training) Providing support to other QC labs (BRA-CHI-URU)
- M.S. degree (Pharmacy, Chemistry, or Biological Science preferred)
- 2-5 years of relevant experience
- Intermediate Level of English
- Excellent written and verbal communication skills.