Product Compliance Associate

Product Compliance Associate

Location: Cambridge, MA

Pay: $25-30/hour

1 year contract

Job Summary

We are looking for a detail-oriented team member to support our compliance and regulatory processes in the biotech/biopharma industry. This role involves documentation, database management, and ensuring adherence to industry regulations and company procedures.

Key Responsibilities

• Assist in preparing Certificates of Quality (CoQ) and collecting required documents
• Maintain and update compliance and regulatory databases
• Support regulatory tasks for product improvements and new product introductions
• Ensure all work follows company policies, procedures, and industry guidelines (e.g. GMP)
• Help track and document non-conformances, deviations, CAPAs, and process improvements
• Follow Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Identify and report issues to supervisors as needed
• Support audit readiness activities and participate in audits and Gemba walks
• Follow all safety procedures
• Understand environmental monitoring and sterility guidelines
• Assist in preparing basic regulatory documents and tracking submissions
• Support general administrative and department tasks as needed
  
  

Qualifications

• HS Diploma or GED
• Familiarity with GMP, CAPA, SOPs, and continuous improvement practices
• Strong attention to detail and ability to follow procedures
• Good communication skills and a team-oriented mindset
  
  

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH