Associate II, Quality Control

Job Description

About This Role

The Quality Control Associate II is responsible for supporting key functional, tactical, and operational aspects of the QC group at the Biogen RTP facility. This includes performing membrane filtration bioburden, kinetic turbidimetric assay (KTA) endotoxin, growth promotion (GP) testing, and all preparatory and post-execution activities associated with this testing in a cGMP manner.

WhatYou’llDo
  • Performs and documents routine testing activities and laboratory inventory/maintenance, as needed.
  • Performs final review for analytical data to support facility monitoring and/or drug substance and drug product routine testing and characterization and attends and participates in relevant meetings.
  • Supports the execution of the transfer, qualification, method development, analytical improvement projects, and validation of analytical methods in collaboration with the Analytical Technology/Development group.
  • Authors action excursions, CAPAs, deviations and laboratory exceptions, investigation protocols, investigation reports, change control requests, and Quality Technical Reports
  • Provides Leadership through effective project management and mentoring as needed

Who YouAre

You have a passion for working in a laboratory and enjoy using your technical knowledge and data to drive key business decisions. You have an enthusiasm for learning new skills and being solutions oriented.

Qualifications

Required Skills
  • Minimally BA/BS degree with 1-2 years of relevant industry experience required.

Preferred Skills
  • Life Sciences degree
  • Attention to detail
  • Good organizational skills
  • Developing ability to multi-task and coordinate multiple activities in parallel with a sense of urgency
  • Ability to prioritize, plan and schedule
  • Strong oral and written communication skills
  • Investigative decision-making skills
  • Problem identification and resolution skills
  • Flexibility supporting schedule and manufacturing activities




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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