Sr Associate I, Quality Control
About The Position
The Sr. Associate I, contributes to the development and implementation of strategic initiatives within the raw material systems and processes at Biogen. Implementation of projects will follow project management principles, driving visibility and accountability within cross-functional teams. Operationally, the Sr. Associate I is responsible to complete subject matter experts (SME) assessments and implementation actions associated with change controls impacting: items (sku’s), testing specifications, vendor change notices and internal testing requirements for raw materials. Additionally, they leverage system metrics and business priorities to drive change control and business projects through to completion. The Sr. Associate I is expected to understand the Quality and Business systems impacting raw materials and may provide technical support during audits/inspections. This requires excellent written and verbal communication skills. Works with Planning, Procurement, Materials Science, Corporate QA, and QC Raw Materials testing labs with respect to VCN, NIR, Global Change Control prioritization and driving completion. The Sr. Associate I will have accountability for completing assessments and tracking / implementing action items in support of Global Change Controls impacting the raw materials business area. Job scope will also include managing projects assigned, ensuring visibility and accountability of stakeholders. The Sr. Associate I will have accountability to ensure compliance with Biogen’s Quality Management System for all activities supported. Where applicable the individual may support deviation resolution impact the raw material business area. The Sr. Associate I is also responsible for: Completing assessments of Global Change Controls impacting raw materials. Driving GCC implementation action plans to ensure changes are brought to completion in a timely manner. Author Quality Technical Reports for Specification Justification Reports supporting technical requirements for Raw Materials. Manage labware requests for changes to testing requirements and updates myCIMs documents (PRCDs / etc.) as required to improve business practices or systems. Drive projects within the raw material space associated with technology deployments, efficiency gains or compliance improvements. Proactively identifying technical gaps and areas for improvement related to quality or process and leads them through completion, can represent in internal and external audit proficiently. The Sr. Associate I will be expected to be a Liaison between peers between partner groups (Materials Science, Site QC teams, Corporate Quality Assurance, etc.). They are expected to work effectively, independently and within a team framework, across all b Additional Information The Sr. Associate I, contributes to the development and implementation of strategic initiatives within the raw material systems and processes at Biogen.
Responsibilities
- Completing assessments of Global Change Controls impacting raw materials.
- Driving GCC implementation action plans to ensure changes are brought to completion in a timely manner.
- Author Quality Technical Reports for Specification Justification Reports supporting technical requirements for Raw Materials.
- Manage labware requests for changes to testing requirements and updates myCIMs documents (PRCDs / etc.) as required to improve business practices or systems.
- Drive projects within the raw material space associated with technology deployments, efficiency gains or compliance improvements.
- Proactively identifying technical gaps and areas for improvement related to quality or process and leads them through completion, can represent in internal and external audit proficiently.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
