Senior Associate I, Quality Control

Job Description

The SeniorAssociate I, Quality Control (Microbiology Lab)is responsible for contributing to key functional, tactical, and operational aspects of the Quality Control group at the Biogen Idec RTP facility. This includes performing QC routine testing and all activities associated with executing this testing, and reviewing and approving test results in a cGMP manner.The Sr. Associate I responsibilities include, but are not limited to, project management, initiation of process improvements, liaison for method transfer, qualification and validation activities, modeling the leadership competencies and aiding in the development of peers.

• Coordinates/performs testing and provides review/approval for analytical data to support release/stability of drug substance and drug product, validation activities, and training data.
• Authors/reviews/approves controlled documents, investigational protocols, investigational reports, change control requests, validation protocols, validation reports, exceptions reports according to applicable procedures. etc.
• Provides technical leadership through effective project management including laboratory investigations, technical problem solving with independence.
• Participates effectively in a leadership or membership role for site cross-functional teams as a representative of the QC laboratory.
• Proactively identifies technical gaps and areas for improvement related to quality or process and leads them through completion.
• Leads the execution of method transfer, method development, method qualification, analytical improvement projects, and validation of analytical methods in collaboration with the Analytical Technology/Development group.

You will possess technical knowledge regarding QC routine testing methodology. You will berequires but is not limited to the following: Demonstrated leadership abilities, Strong presentation, oral and written communication skills; ability to communicate with management, peers and subordinates effectively, Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel, Broad and deep understanding of biological science principles, Demonstrated instrument/method troubleshooting and problem solving skills, Knowledge of FDA/EMEA regulations and compliance.

Qualifications

• B.S. degree with8+ years of industry (Pharma/ Biotech)
• M.S. degree with5+ years ofindustry (Pharma/ Biotech)

• B.S. degree -Biological science-Microbiology
• M.S. degree -Biological science-Microbiology
• Method Qualification/Equipment Validation
• Project Management
• Microbiology experience
• Experience Managing Change Controls and Performing Area Assessments
• Experience initiating Lab Exceptions/OOSs/Events in Trackwise
• Effective Communication Skills
• LIMS

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 usasa 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