Senior Associate I, QC-Stability

Job Description

About This Role

Responsible for contributing to key functional and operational aspects of the Product Quality Technical Services (PQTS) group at Biogen for the stability program of commercial/clinical products. This includes maintaining data, data verification of Annual Product Reviews for release and stability, review of stability sections for submissions, stability study management within LIMS, change control management, and specification management. Proficient in understanding of Quality Systems including LIMS and PLM.

WhatYou’llDo
  • Perform data verification of stability reports and regulatory submissions
  • Manage stability studies in Labware LIMS
  • Collaborates with Sample Control and QC laboratories to ensure proper testing and reporting of stability samples.
  • Provide operational support through effective project management, status tracking, data analysis, presentations, and communication.
  • Author stability assessment for Anomalous Results (ARs) and Out of Trend (OOT) stability results.
  • Management of specifications in Labware LIMS and PLM

Who YouAre

You enjoy stability or specification management and are passionate about using data to drive key business decisions. You love learning new skills and working through collaboration.

Qualifications

Required Skills
  • B.S. with 8+ years experience; M.S. with 5+ years experience
  • Direct experience with management of stability studies in Labware LIMS and change control
  • Broad knowledge and application of operations/quality systems/directives
  • Excellent technical writing skills
  • Author technically sound simple to moderately complex reports with limited guidance.
  • Actively participate and/or leads projects
  • Accountability for self and immediate work team through delivery of appointed deliverables.
  • Ability to communicate with management, peers and subordinates effectively; strong organizational skills, ability to multi-task and coordinate multiple activities in parallel and demonstrated problem solving skills, knowledge of FDA/EMA regulations and compliance.
  • Leadership competencies include: Follow up, Decision Making, Communication, Collaboration and Innovation.




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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