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- Bachelor's Degree preferably in Life Sciences discipline
- 5 yrs. relevant technical experience.
- Experience in drug product batch record review and disposition preferred.
- Experience with deviations varying in complexity.
- Strong knowledge in FDA/EMA regulations and compliance.
- Strong organizational skills; multi-task.
- Investigative mindset and solid decision-making skills.
- Critical thinking skills and inquisitive attitude.
- Experience in aseptic fill/finish manufacturing operation.
Sr. Associate I, Quality Assurance - Research Triangle Park, United States - Biogen Idec
Description
Job Description
About This Role
The Sr. Associate I 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: (1) Batch Records, (2) Exceptions/Investigations and (3) QA Controlled Documentation. It is expected that this role will report directly into a Sr. Manager.
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
QA Controlled Documentation: Review and approve content for controlled documents within the quality system to ensure compliance with procedural requirements and standards. Additionally, technical reports issued requiring a Quality review are in scope of this role.
Who You Are
You are task driven and focused; you enjoy taking action to resolve, remediate and/or improve processes. You thrive collaborating with others and you bring a high level of agility and customer service to any team.
Qualifications
Why Biogen?
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.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.