Wole Akindahunsi

Quality Control Bioassay Associate Ii @Biogen

Durham, NC, US

Performs release and stability testing and all associated activities associated with this testing.• Responsibilities include, but are not limited to, training, testing support for 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, GCP and GLP requirements, a basic understanding of FDA/EMA regulations, effective interactions/communication with Quality management, personal development, and support of investigations (21 CFR Part 11)• Participates in basic technical problem solving and seeks guidance on resolution.• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.• Initiate Invalid Assays• Possess good working knowledge of operations/quality systems, understands work processes of QC operations/support teams (e.g. strong test method/scientific base). • Completes deliverables within targeted timeframes with good quality.• Draw conclusions from data interpretation. • Solid technical writing skills, author’s documents with input & guidance and conducts compliance/work impact assessments as appropriate. Works on process improvements, actively supports management & QC teams.

Allen University

Bachelor of Science - BS, Biology, General

Allen University

Bachelor of Science (B.S.), Biology, General

University of North Carolina at Greensboro

Master of Science (M.S.), Biology, General