Biogen

Biogen

Associate III, Quality Assurance

Research Triangle Park, NC, USA · Mid

Sponsorship not specified$69k-$90kDetected 20 hours ago
GMPFDA RegulatoryLeadershipCommunicationWritingGxP

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odds of building a lasting career here

37Risky
Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70

Thin sponsorship signal and lottery-bound (~15% per draw). A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.

Lottery odds assume a STEM candidate.

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

14 transfer filings in the last year, covering 14 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • This individual contributor role requires sound judgment, mature situational leadership and the ability to work independently while collaborating across functions and organizational levels.

Responsibilities

  • Perform manufacturing-floor record review, observations, WORCs and inspection-readiness walkthroughs
  • Support resolution of technical and compliance issues or gaps of low to moderate complexity
  • Support the QA Lead for NPI technology transfers and restart programs
  • Provide technical writing, investigation support, root cause analysis and impact assessment
  • Support CAPA closure and review or approval of associated documentation with management oversight

Requirements

  • You are a detail-oriented quality professional who applies sound judgment, regulatory knowledge and a practical understanding of manufacturing to protect product quality.
  • 2+ years of related experience working in a quality GMP biopharma or pharma environment
  • Working knowledge of GxP regulations, cGMP requirements and relevant FDA/EMA expectations
  • Experience reviewing controlled manufacturing and disposition documentation

Nice to have

  • Bachelor's Degree required, preferred in a life science discipline
  • Preferred Skills

Compensation

  • Tuition reimbursement of up to $10,000 per calendar year

Benefits

  • Medical, Dental, Vision, & Life insurances
  • Paid Maternity and Parental Leave benefit
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Employee stock purchase plan
  • Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Company info

  • We are a global team with a commitment to excellence, and a pioneering spirit.
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 401(k) program participation with company matched contributions
  • As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.

This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.