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Quality Assurance Associate III
2 months ago
About the Role
This role operates on a 6 PM to 6 AM schedule, following a 2,2,3 rotation.
The Quality Assurance Associate III plays a crucial role in supporting 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 key quality activities, including: (1) providing shop floor support to ensure adherence to batch records and procedural standards, (2) reviewing and approving exceptions, and (3) addressing operational requirements that necessitate quality assurance approval.
Key Responsibilities
- Ensures that product documentation and related materials used in cGMP production activities are compliant and suitable for release or further processing.
- Facilitates the resolution of exceptions, ensuring adherence to established procedures and processes, including comprehensive root cause analysis and well-supported rationales.
- Continuously monitors relevant data dashboards and collaborates with stakeholders to enhance process efficiency and effectiveness.
- Assists Quality Management and Operations teams in the coordination, preparation, and follow-up of internal and external audits and inspections as necessary.
Candidate Profile
The ideal candidate is detail-oriented, focused on continuous improvement, and possesses strong analytical skills. You are adept at asking insightful questions and excel in root cause analysis and troubleshooting. Additionally, you have excellent communication and collaboration abilities, allowing you 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 the biotech or pharmaceutical sectors.
- Familiarity with FDA/EMA regulations and compliance standards.
- Strong organizational capabilities.
- Understanding of quality concepts and the ability to implement them effectively.
- Ability to devise innovative solutions to moderately complex issues.
- Detail-oriented mindset.
- Exceptional oral and written communication skills.
Preferred Qualifications
- Experience in parenteral filling processes.
Why Choose Biogen?
Biogen is a global organization committed to excellence and innovation. As a mid-sized biotechnology firm, we offer the stability and resources of an established company while fostering an environment that values individual contributions. Our team consists of talented and passionate professionals who have unique opportunities for growth and skill development. Together, we strive to deliver life-changing therapies, with every role being essential to our mission.
At Biogen, we prioritize a culture of inclusion and belonging that reflects the diverse communities we serve. We recognize that diverse backgrounds, cultures, and perspectives enhance our strength and innovation, and we are dedicated to building teams where every employee feels empowered and inspired.
All qualified applicants will receive consideration for employment without regard to any protected characteristic. Biogen is an E-Verify Employer in the United States.
