Job description
About This Role
Associate III is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral facility. Specifically, this role will have primary quality oversight of the following activities: Batch Records (Compounding, Filling, Visual Inspection and Packaging), Exceptions (Deviations, Alert/Actions) and CAPA. It is expected that this role will report directly into a Sr. Supervisor.
What You’ll Do
- Product Disposition: Reviews documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.
- Exceptions, Complaints and CAPA: Assesses criticality of exceptions/investigations for product impact. Performs thorough reviews of the investigations and provides feedback to the department owner. Supports complaint investigations with the ability to analyze the complaint defect and determine potential areas within the process that may have attributed to the defect. Collaborates with associated departments to determine the appropriate
Who You Are
Looking for someone who is task driven and focused on taking action to resolve, remediate and/or improve. Collaborative person capable of being both agile and customer focused.
Required Skills
- Bachelor’s degree strongly preferred
- Minimally 3 yrs. relevant technical experience
- Quality oversight of a biotech or pharmaceutical manufacturing operation
- Experience in drug product batch record review and disposition
- Experience with deviations varying in complexity as both an author and approver
- Proficient knowledge in FDA/EMA regulations and compliance
- Strong organizational skills; multi-tasking
- Investigative mindset and solid decision making skills
Preferred Skills
- Experience in aseptic fill/finish manufacturing operation
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 us as a 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. Together, we pioneer. Together, we thrive.
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