Associate III, Quality Control (2 Identical Roles Currently Open For This Requisition)

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Job Description

About This Role

The Associate III is responsible for supporting, leading/participating in team initiatives regarding compliance, documentation, investigations, deviations, OOS/AR, systematic IA’s, environmental excursions, periodic reviews, Annual Product Reviews and retest protocols. Drive CAPA, periodic review & change control activities. Mentor others in aspects of quality impact assessment (including QA & regulatory notification) quality systems, and risk assessment. Provides support and presents for internal & external regulatory inspections, as applicable. Keen understanding of the laboratory operations/testing process, equipment/instrumentation, and analytical test methods. Able to apply scientific understanding of validation & data analysis for reporting results.

WhatYou’llDo
  • Author technically-sound simple to moderately complex reports with limited guidance.
  • Routinely contribute to and support complex problem solving and manage noncomplex problem solving.
  • Proactively identify, communicate and monitor business changes that could impact quality or compliance within the department & across departments.

Who YouAre

You are a leader and are passionate about solving technical, compliance gaps and areas for improvement or remediation related to quality or process. You are confident in making decisions that have potential compliance impact to methods, results, product, and/or Quality systems.

Qualifications

Required Skills
  • B.S. with 4+ years experience or M.S. with 2+ years experience in comparable role with GMP, compliance experience.
  • Excellent technical writing skills, strong presentation, oral and written communication skills.
  • Strong organizational skills and ability to multi-task / coordinate multiple activities in parallel.
  • Demonstrated problem solving skills with a keen understanding of the laboratory operations/testing process, equipment/instrumentation, and analytical test methods.
  • Able to work effectively, independently and within a team framework across business and multiple levels.

Preferred Skills
  • Proficient in Trackwise, LabWare LIMs.




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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