Biogen Sr Associate I, Quality Assurance in Cambridge, Massachusetts
This position includes Regulatory Starting Materials, Cell Banks, API, Drug Substance, Drug Product, Intermediates, Device Components, Device, and Finished Product. The incumbent is responsible to adhere and support Quality Management System and GMP Compliance Programs to assure product integrity and compliance with regulatory guidelines and internal/global standards and procedures. This person will interact with External Manufacturing, and Clinical Drug Supply to ensure uninterrupted supply of product. This person may also write and revise SOPs (Standard Operating Procedures) as it relates to batch disposition activities and may be asked to assist in deviations management, CAPAs, change controls, investigations, and recalls using scientific principles as needed.
Prepares batch record documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards. Resolves minor issues found during documentation review (documentation errors, missing information) as directed by Biogen SOPs. Resolves major issues that are not defined by SOP. Generates Certificates of Conformance for batch release. Review and verification of batch release documentation according to local procedures and product specific checklists. Maintain checklists and update when necessary. Coordinate with GEQ quality Engineering to request all information needed for review.
Performs product availability tasks in EBS to facilitate further manufacture, transport and release.
Reviews and performs QA approval on release relevant documents, Deviations, CAPAs, Change-Controls as needed and as appropriate. Participate as a GEQ Release representative for investigational medicine products on cross-functional teams and projects.
Collect and analyze data supporting goals and department metrics. Data to be collected is determined by the area of responsibility and defined metrics. Such data are required to measure the group performance and create further KPIs relevant for communication to internal and external stakeholders.
And other job duties may be assigned from time to time
Education: Bachelor’s Degree in scientific field with 3+ years’ experience in relevant industry or equivalent.
Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Requires a good understanding of the underlying principles and concepts of the release process, and a general understanding of the manufacturing and QC steps.
Operations experience in Quality Assurance, Quality Control, and Manufacturing including batch record review.
Demonstrated ability to consistently meet or exceed project deadlines
The primary role of this position is to review and approve executed batch records and issue disposition documents (release or rejection) for the timely disposition of Biogen’s investigational medicine products manufactured and tested at CMOs.