Job Description

The QC Associate I is responsible for supporting key functional, tactical, and operational aspects of the QC Chemistry group at Biogen.

• Performs release and stability testing and all associated activities associated with this testing
• Lead method transfer/qualification/validation activities in conjunction with partner groups
• Draft technical protocols and reports to support laboratory functions, such as investigations and method development/optimization efforts
• Support for assay control & reference standard qualification
• Robust and compliant cGMP documentation practices
• Providing sound technical support as a subject matter expert in key functional areas, training/mentoring other analysts as needed
• Represent QC on cross functional teams to ensure group’s needs and compliance requirements are addressed
• Effective interactions/communication with Quality management

Qualifications

• Minimally BA/BS in Life Sciences with 0-6 months of relevant experience required.
• Broad understanding of the Biogen Quality Systems.
• Adherence to all GMP requirements
• HPLC, GC, KF, & Dissolution experience is strongly preferred. LCMS experience is a plus
• Good understanding of FDA/EMA regulations
• Lead projects within the department and support of investigations.
• Support activities related to interviewing and training of employees, identifying, and implementing corrective actions on the floor
• Able to work effectively within the group, within and external to Quality and across sites

Additional Information

The QC Associate I is responsible for supporting key functional, tactical, and operational aspects of the QC Chemistry group at Biogen. The candidate will also perform release and stability testing and all associated activities associated with this testing.