Compliance Expert in GMP Environments

7 days ago


Cary, North Carolina, United States Arcadis Full time
About the Role

Arcadis is seeking a Compliance Expert in GMP Environments to join our team in Cary, NC. This individual will be responsible for managing deviations in a cGMP environment and ensuring compliance with regulatory requirements.

The ideal candidate will have experience working in electronic quality management systems and a strong understanding of cGMP requirements for manufacturing. They will also possess excellent communication and problem-solving skills, as well as the ability to work collaboratively across functions.

Key Responsibilities:

  • Manage, write, and review deviations and investigations
  • Identify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAs
  • Expertise in cGMP requirements for manufacturing
  • Electronic Quality Management System experience
  • Comprehensive understanding of cell and gene manufacturing operations, maintenance/calibration, engineering, and validation
  • Closure of Deviations on Time for batch-delivery commitments

Requirements:

  • Bachelor's or Master's degree in a scientific field
  • Pharmaceutical or biotech experience, particularly in drug substance/drug product manufacture, quality control, and regulatory affairs
  • Effective communication, problem-solving, and teamwork abilities
  • Regulatory inspection experience
  • Familiarity with global regulations and standards
  • Solution-driven mindset, enthusiasm for collaboration, and dedication to delivering high-quality work
  • Analytical skills and attention to detail
  • Positive team dynamics and commitment to excellence
  • Punctual delivery of outstanding results
  • Legal US work authorization and ability to gown and work in a cleanroom

Arcadis Benefits

Arcadis offers an estimated salary range of $125,000 - $155,000 annually, commensurate with qualifications, experience, and geographic location. Our comprehensive benefits package includes health insurance, paid time off, retirement savings plan, professional growth opportunities, and rewarding work environment.



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