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Quality Assurance Associate III
2 months ago
Position Summary
This role operates on a night shift schedule from 6 PM to 6 AM, following a 2,2,3 rotation.
The Quality Assurance Associate III plays a pivotal role in supporting critical strategic, tactical, and operational functions within the Quality Assurance department at Biogen's Research Triangle Park (RTP) Drug Product Parenteral Facility. This position is primarily responsible for overseeing quality assurance activities, which include: (1) Providing shop floor support to ensure adherence to batch records and procedural guidelines, (2) Reviewing and approving exceptions, and (3) Addressing operational requirements that necessitate QA approval.
Key Responsibilities
- Ensures that product documentation and related materials are compliant and assesses their acceptability for use in cGMP production activities and/or product release for further processing and distribution.
- Facilitates the closure of exceptions while ensuring compliance with established procedures and processes, including comprehensive root cause analysis and well-supported rationales for conclusions.
- Actively monitors relevant data dashboards and collaborates with stakeholders to enhance process effectiveness and efficiency.
- Assists Quality Management and Operations teams in coordinating, preparing for, and following up on internal and external audits and inspections as necessary.
Candidate Profile
The ideal candidate is detail-oriented, focused on continuous improvement, and adept at root cause analysis and troubleshooting. Strong communication and collaboration skills are essential, along with the ability to engage effectively across all organizational levels.
Qualifications
- Bachelor's degree in a scientific or biotechnology-related field.
- A minimum of 2 years of relevant technical experience in quality oversight, preferably within a biotech or pharmaceutical manufacturing environment.
- General knowledge of applicable FDA/EMA regulations and compliance standards.
- Strong organizational capabilities.
- Basic understanding of Quality concepts and the ability to implement them effectively.
- Capacity to devise innovative solutions to moderately complex issues.
- Detail-oriented with a strong aptitude for accuracy.
- Excellent verbal and written communication skills.
Preferred Qualifications
- Experience in parenteral filling processes.
Why Choose Biogen?
Biogen is a global leader committed to excellence and innovation. As a mid-sized biotechnology company, we offer the stability and resources of an established organization while promoting an environment where individual contributions are valued. Our team comprises talented and passionate professionals who enjoy unparalleled opportunities for learning, growth, and skill enhancement. Together, we strive to deliver life-changing therapies, with every role being crucial to our mission.
At Biogen, we prioritize a culture of inclusion and belonging that reflects the diverse communities we serve. We recognize that varied backgrounds, cultures, and perspectives strengthen our company and foster innovation. We are dedicated to building teams where every employee feels empowered and inspired.
We are an equal opportunity employer and welcome all qualified applicants without regard to any protected status.
