Sr. Associate II, Quality Assurance at Biogen in Research Triangle Park, North Carolina

Job Description:

Job Description

About This Role

The Senior QA Associate II in the Quality Systems organization is responsible for understanding quality systems, contributing to oversight of quality systems, and maintaining GMP activities at the Biogen Research Triangle Park (RTP) facility. The primary responsibilities include quality compliance of QC exceptions and CAPAs, performing timely and accurate issuance of GMP documents and records required to support internal site operations, authoring Site Reports , facilitating SMR/QMR meetings, facilitating governance boards and the review and approval of site-specific GMP documents for compliance to applicable regulatory and corporate guidance documents, and consistency with business source documentation.

What You'll Do

• Ensure compliance of Quality Control exceptions (Investigations, LEs, OOSs, ARs, and PEs) and CAPAs to site, corporate, and regulatory guidance documents.


• Review and approve site-specific GMP documents and records. Assess and approve document change controls for the RTP Drug Product sites including QC focused changes.


• Contribute to oversight of quality systems and GMP activities, as well as site performance monitoring systems, such as Site Management Review, Site Governance Boards (DRB and CARB), and site contact for global quality systems meetings/projects.


• Issuance of Batch Production Records, Solution Lot Records, Labels, and Logbooks.


• Identify and implement Quality System improvements.


• Develop and deliver training on basic GxP quality systems. Provide mentorship and training within and across functions.


• Prepare for and support site inspections and audits.


• Provide quality system expertise within functional area and in cross-functional meeting formats.


• Serve as a site lead for quality systems and actively participate in global quality systems meetings/projects.

Who You Are

You demonstrate the capability to make autonomous quality decisions and tackle intricate tasks without supervision. Your keen eye identifies system and compliance gaps and you actively contribute creative solutions to complex problems, drawing on ingenuity and teamwork. You recognize and support the strategic vision of the Quality organization.

Qualifications

• Bachelor's Degree, preferably in Engineering, Life Science or Technical discipline.


• 6 years of relevant industry experience, preferably in pahrmaceutical or biotechnology.


• Knowledge of FDA/EMEA regulations and compliance.


• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to effectively communicate and collaborate with technical and senior management staff.


• Experience in managing multiple, competing priorities in a fast-paced environment and dealing with ambiguity.


• Demonstrated troubleshooting and strong problem-solving skills and the ability to develop innovative/creative solutions to issues of moderate or high complexity.


• Demonstrated leadership abilities and can lead complex problem-solving initiatives across functions or globally.

Additional Information

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.

PDN-9bd16ea5-270d-479c-af69-a91679797380 Apply Now