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