Associate III, Quality Control Microbiology

Job Description

The schedule for this position is M-F Business hours (full time, on-site)

About This Role

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

What You'll Do

• Performs testing of bioburden and endotoxin, initiate deviations, IA, and A/A. Capable of performing 50% of assays within the group
• May author design protocols, change control requests, and Quality Technical Reports, as directed
• Performs document revisions and provides technical leadership as a subject matter expert in one or more disciplines
• Provides timely review/corrections for data and documentation
• Participates in the execution of method development, method qualification
• Supports maintenance of effective laboratory systems, including instruments and equipment to ensure integrity of all laboratory results
• Other duties as assigned

Qualifications

Required Skills  

• Bachelor’s Degree in a life sciences related field
• 2-4 years of experience working in Quality Control in a biotech/pharmaceutical GMP environment
• Microbiology experience, including expertise in bioburden and endotoxin assays
• Experience working in a drug substance and/or drug product environment

Preferred Skills 

• Experience using LabWare (LIMS system)
• Method qualification experience
• Microbial identification experience

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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.