Associate III, Quality Control

Job Description

The QC Associate III is responsible for supporting key functional, tactical, and operational aspects within QC Microbiology. Responsibilities include, but are not limited to, training, testing support for release and stability, support for transfer, qualification/ validation activities, robust and compliant cGMP documentation practices. A fundamental understanding of the Biogen Quality Systems and able to apply it to their daily functions.  Adherence to all GMP requirements, effective interactions/ communication with Quality Control management and support of investigations. The QC Associate III should possess skills to work effectively, attention to detail, within a team framework, and across all business areas and levels of the organization. This position requires good written and verbal communication skills.

What You’ll Do  

• Performs in-process, release, and stability testing
• Coordinates testing and performs test reviews of analytical data
• Authors and reviews protocols, change control requests and Quality Technical Reports
• Participates in the execution of method transfer/development/qualification
• Participates in a leadership or membership role for cross-functional teams as the QC Microbiology representative
• Support Microbiology Laboratory for instrument onboarding, process improvement and project management
• Provide Microbial Assessments and technical support for investigations and studies

Who You Are  

You enjoy being part of a high-paced team dynamic and ready to take the lead in delivering on the business imperatives. You thrive on using your knowledge and experience in bringing in new product and processes and being a key stakeholder across multiple functionalities.

Qualifications

Required Skills  

• Technical, AS, or Bachelor’s degree
• 0-2 years in comparable/ related role with laboratory experience
• Proficient with Microsoft Word/ Excel/ Powerpoint 
• Understanding of cGMP’s, regulatory requirements
• Strong communication skills

Preferred Skills 

• Bachelor’s degree (Biological Sciences)
• Understanding of Instrument Validation
• Microbial Identification experience
• Sterility experience
• Technical writing skills
• LIMS experience 

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.