Job Details

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

  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.

• 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

• 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