Job Details

  • Title: Compliance Specialist
  • Code: RCI-03068
  • Location: Framingham Massachusetts (MA) 01701
  • Posted Date: 10/20/2020
  • Duration: 6 Months
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  Job Description

The Compliance Specialist uses expert knowledge of Compliance and GXP to manage Investigations and CAPAs within Engineering and Facilities. This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP’s.

Required:
• Bachelor’s Degree with 3-5 years of experience
• Knowledge of Biologics Manufacturing and Engineering
• Understanding of GXP and how it applies to specific responsibilities
• Excellent written and verbal English language skills
• Experience in cGXP manufacturing environment
• Experience in troubleshooting, investigating, root cause analysis and technical writing in a GXP environment
• Ownership and Management of Deviations, CAPAs, Effectiveness Reviews and Change Controls

Prefered:
• Bachelor’s Degree in Biology, Chemistry, Biochemistry or Chemical Engineering
• Clean Utility Experience
• Validation Experience
• Facility Maintenance Experience

Special Working Conditions
• Ability to gown and gain entry to manufacturing areas