Associate Iii, Quality Assurance (on The Floor, Swing Shift)

Biogen

Research Triangle Park, NC, United States
$69,000.00-$90,000.00; bonus/equity: short term + ...
Cgmp compliance
Gxp regulations
Quality systems understanding
Ensure disposition documentation and other documents supporting batch and cell bank disposition are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution

Job Summary

  • Ensure disposition documentation and other documents supporting batch and cell bank disposition are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.
  • Supports resolution of both technical and compliance issues/gaps of low complexity and assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems.
  • Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being.

Matching Summary

Ensure disposition documentation and other documents supporting batch and cell bank disposition are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.

Salary

$69,000.00-$90,000.00; Bonus/Equity: Short term and long-term incentives; Benefits: Medical, Dental, Vision, Life insurances, Fitness programs, Disability insurance, Paid time off, Holidays, Paid Maternity/Parental Leave, 401(k) match, ESPP, Tuition reimbursement

Skills & Requirements

Must-have

  • cGMP compliance
  • GxP regulations
  • Quality Systems understanding
  • batch disposition documentation review
  • manufacturing floor observation
  • CAPA resolution support

Nice-to-have

  • independent and team work
  • collaboration across business areas
  • training within and across functions
  • column packing experience

Key Requirements

  • Bachelor’s Degree in life sciences
  • Minimum 2 years GMP pharma/biotech QA experience
  • Ability to work independently and in a team
  • Excellent communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter