Quality & Safety Investigator I/II

Biogen, Inc.; North Carolina; In loco; USD 69.000 - 111.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental, Vision & Life ins.

Paid vacation with shutdown days

401(k) with match

Tuition reimbursement

Employee stock purchase plan

Paid parental leave

Descrizione del lavoro

Biogen, Inc. seeks an Investigator within Human Performance & Investigations to lead quality and safety event investigations across manufacturing operations.

You will apply structured root cause analysis and HOP principles to identify improvements, reduce recurrence risk, and enhance operational reliability. This role collaborates with manufacturing, quality, engineering, EHS, and site leadership to drive organizational learning and performance improvements, with standard weekday shifts and

Competenze

• Bachelor’s degree from an accredited college or university, STEM preferred.
• Associate’s degree, STEM preferred and at minimum 2 years of direct experience
• A High School Diploma (or equivalent) and at minimum of 4 years of direct experience
• Experience conducting investigations, root cause analyses, or operational problem-solving activities within regulated environments
• Strong analytical and critical thinking skills with the ability to evaluate complex information and develop practical solutions
• Excellent technical writing and documentation abilities
• Strong facilitation, communication, and stakeholder management skills
• Ability to effectively collaborate across multiple functions and levels of the organization
• Working knowledge of quality systems, safety programs, and compliance requirements within manufacturing, laboratory, industrial, or regulated environments
• Demonstrated ability to manage multiple priorities and meet critical deadlines

Mansioni

• Lead investigations for quality deviations, safety incidents, alert actions, and remedial action requests across manufacturing operations
• Conduct interviews, gather and analyze data, facilitate investigation meetings, and apply systematic cause analysis methodologies to identify root and contributing causes
• Author clear, concise, and compliant investigation reports within designated quality and safety systems
• Partner with cross‑functional stakeholders to develop effective corrective and preventive actions (CAPAs) that reduce recurrence risk
• Ensure investigations are completed in alignment with Quality Management System (QMS) requirements, regulatory expectations, and established timelines
• Share investigative findings and lessons learned across the organization to drive continuous improvement and operational excellence
• Support complex and high‑impact investigations as needed
• Present investigation outcomes and supporting documentation during internal and external audits

Conoscenze

Investigations

Root cause analysis

Data analysis

Technical writing

Facilitation

Cross-functional collaboration

Formazione

Bachelor’s degree in STEM

Associate’s degree, STEM

High School Diploma + 4+ years experience

Descrizione del lavoro

Biogen, Inc. seeks an Investigator within Human Performance & Investigations to lead quality and safety event investigations across manufacturing operations.

You will apply structured root cause analysis and HOP principles to identify improvements, reduce recurrence risk, and enhance operational reliability. This role collaborates with manufacturing, quality, engineering, EHS, and site leadership to drive organizational learning and performance improvements, with standard weekday shifts and