Senior Quality Assurance Associate

2 weeks ago

Triangle Township, United States Biogen Full time
Job Overview

Position Summary

This role operates on a 6 AM to 6 PM schedule following a 2,2,3 rotation.

The Senior Quality Assurance Associate plays a crucial role in supporting the strategic, tactical, and operational facets of Quality Assurance at Biogen's Drug Product Parenteral Facility located in Research Triangle Park (RTP). This position is primarily responsible for overseeing key quality activities, including: (1) Providing support on the shop floor to ensure that critical processes adhere to batch records and procedural guidelines, (2) Reviewing and approving exceptions, and (3) Addressing operational requirements that necessitate Quality Assurance approval.

Key Responsibilities

  • Ensures that product documentation and related materials are compliant and suitable for use in cGMP production activities or for product release.
  • Facilitates the resolution of exceptions, ensuring adherence to 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 preparing for and following up on internal and external audits and inspections as needed.
  • Supports QA Management with additional responsibilities tied to the daily execution of Quality Management Systems necessary for maintaining cGMP compliance, ensuring the safety, efficacy, and purity of Biogen's manufactured products.
  • Contributes to GxP quality systems training and provides mentorship across various functions.

Candidate Profile

The ideal candidate is detail-oriented, focused on continuous improvement, and possesses strong analytical skills. Excellent communication and collaboration abilities are essential, along with the capacity to engage effectively across all organizational levels.

Qualifications

  • Bachelor's degree in a scientific or biotechnology-related field.
  • A minimum of 4 years of relevant technical experience in quality oversight, preferably within a biotech or pharmaceutical manufacturing environment.
  • General knowledge of 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 with strong written and verbal 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 business while nurturing an environment where individual contributions are valued. Our team comprises talented and passionate professionals who enjoy unparalleled opportunities for growth and skill enhancement. Together, we strive to deliver transformative medicines, with every role being vital to our mission. We prioritize a culture of inclusion and belonging, reflecting the diverse communities we serve. We believe that diverse backgrounds and perspectives foster a stronger, more innovative company.

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.

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