Associate I, Quality Control

Job Description

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

The Quality Control Associate I has frequent interaction with Quality Control Supervisors and Managers, the Associate Director of QC Chemistry as well as laboratory 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 I is responsible for generating, communicating and coordinating test results as appropriate.

What You'll Do
  • Performs release and stability testing.
  • Author 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 appropriate Quality or Development group.
  • Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.
  • Provides timely review/corrections for data and documentation generated for or by QC Chemistry.

Who You Are

You are motivated team player with an existing technical understanding and desire to further develop yourskills and contribute inensuring that release, stability testing and related activities are completed in a timely manner according to established performance expectations. You willgain personal knowledge regarding QC Chemistry release and stability methodologies through daily activities and apply that knowledge to develop trouble shooting and root cause analysis skills.

Qualifications

Required
  • B.S. degree (biological science preferred; 0-2 years of relevant experience) or A.S. degree (biological science preferred; 8+ years of relevant experience)
  • Demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology
  • Understanding of basic scientific principles
  • General knowledge of FDA/EMEA regulations and compliance

Preferred
  • Ability to communicate with peers and management
  • Effective organizational skills
  • Ability to multi-task and coordinate multiple activities in parallel
  • Developing or demonstrated problem solving skills
  • Developing or demonstrated instrument/method troubleshooting 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.

283013455