• Product Compliance Associate

    Astrix Technology (Cambridge, MA)


    Product Compliance Associate

     

    Quality Assurance

    Cambridge, MA, US

    Pay Rate Low: 25.00 | Pay Rate High: 30.00

     

    + Added - 01/10/2025

     

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    Product Compliance Associate

    Pay: $25-30/hour

    1 year contract/ PART TIME

     

    _** Remote Work **_

    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 mindsetThis 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

     

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.