Associate II, Quality Control

Job Description

The Quality Control Associate II will support the department to ensure that release and stability testing and related activities are completed in a timely manner according to established expectations. Additionally, the Associate II will actively support the completion of all departmental milestones associated with clinical and commercial product manufacture and testing.

The Quality Control Associate II has frequent interaction with the Supervisor, Manager and Associate Director of QC Chemistry as well as peers (Associate I, II, III) with the purpose of performing release/stability testing, supporting laboratory exceptions, personal development, and testing-related issues. Importantly, the Associate II is responsible for generating, communicating and coordinating test results as appropriate, to support departmental, site, and global initiatives.

What You'll Do
  • Performs release and stability testing
  • Authors investigational protocols, investigational reports, change control requests, and Quality Technical Reports, etc.
  • 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
  • Provides technical leadership as a subject matter expert in one or more disciplines
  • Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.
  • Provides sound technical review for data and documentation generated for or by QC Chemistry.

Who You are

You have developed solid technical abilities, and are able to apply knowledge from past experiences to make or recommend routine decisions regarding laboratory issues. You are able to make decisions or recommendations regarding investigations and compliance concerns that have the potential to impact product and/or impact compliance.

Qualifications

Required
  • M.S. degree (biological science preferred), B.S. degree (biological science preferred), A.S. degree (biological science preferred)
  • 0-2 years of relevant experience (M.S. degree), with 2-5 years of relevant experience (B.S. degree), 10+ years of relevant experience (A.S. degree)
  • Possess technical knowledge regarding Quality Control Chemistry release and stability methodology
  • Demonstrated instrument/method troubleshooting skills
  • Knowledge of FDA/EMEA regulations and compliance.

Preferred
  • Demonstrated technical abilities
  • Solid presentation, oral and written communication skills
  • Ability to communicate with peers and management
  • Effective organizational skills
  • Ability to multi-task and coordinate multiple activities in parallel
  • Demonstrated problem solving skills




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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