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 with a 2,2,3 rotation.

The Senior Quality Assurance Associate plays a pivotal role in supporting the 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 quality oversight in several key areas: (1) Providing shop floor support to ensure critical operations adhere 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 are compliant and assesses their acceptability for use in cGMP production activities and/or product release for further processing and distribution.
  • Drives the resolution of exceptions, ensuring adherence to procedures and processes, including comprehensive documented 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 needed.
  • Supports QA Management with additional responsibilities related to the daily implementation of Quality Management Systems to maintain cGMP compliance, ensuring the safety, efficacy, and purity of Biogen's manufactured products.
  • Facilitates GxP quality systems-related training and provides mentorship and training across functions.

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 4 years of relevant technical experience in quality oversight, preferably within a biotech or pharmaceutical manufacturing environment.
  • General understanding of applicable FDA/EMA regulations and compliance.
  • Strong organizational capabilities.
  • Basic understanding of Quality concepts and the ability to implement them effectively.
  • Capacity to develop innovative solutions for moderately complex issues.
  • Detail-oriented mindset.
  • Excellent verbal and written communication skills.

Preferred Qualifications

  • Experience in parenteral filling.

Why Choose Biogen?

Biogen is a global team dedicated to excellence and innovation. As a mid-sized biotechnology firm, we offer the stability and resources of an established company while nurturing 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 medicines, with every role being crucial to our mission. We are committed to fostering a culture of inclusion and belonging that reflects the diverse communities we serve. We believe that diverse backgrounds, cultures, and perspectives strengthen our company and drive innovation.

Biogen is an E-Verify Employer in the United States.

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