• Regulatory Compliance Auditor (GLP/GxP)

    Astrix Technology (Ridgefield, CT)


    Regulatory Compliance Auditor (GLP/GxP)

     

    Regulatory Affairs

    Ridgefield, CT, US

    Pay Rate Low: 35.00 | Pay Rate High: 36.50

     

    + Added - 19/05/2025

     

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    _Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a_ **_Regulatory Compliance Auditor_** _to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference!_

     

    **Job Title:** Regulatory Compliance Auditor (GLP/GxP)

    **Location:** Fairfield County, CT

    **Contract length:** 6 months

    **Pay rate:** $35/ hr.- $36.50/ hr.

    Position Summary:

    The Regulatory Compliance Auditor is responsible for supporting the implementation of a regulatory compliance program to ensure adherence to applicable regulations (e.g., FDA, EMEA, NRC, DEA, USDA) and internal quality standards, including SOPs, policies, and good scientific and documentation practices.

     

    This role involves auditing studies, reviewing procedures, identifying and reporting compliance deviations, recommending corrective actions, and verifying their successful implementation.

    Key Responsibilities:

    + Review procedures and documentation to ensure compliance with GxP requirements and internal standards.

    + Conduct audits to support GLP studies (e.g., protocols, amendments, toxicokinetic and bioanalytical reports).

    + Issue electronic audit reports and track follow-up actions.

    + Manage electronic systems for audit tracking and document storage.

    + Maintain and update the GLP Master Schedule and support audit-related requests.

    + Conduct internal facility audits and help during external audits and regulatory inspections.

    Requirements:

    + Bachelor’s degree or equivalent with a minimum of 3 years of experience in the pharmaceutical industry or another regulated environment.

    + Experience in GLP auditing or similar compliance functions.

    + Working knowledge of GLP, GMP, and related regulatory guidance.

    + Ability to work independently with moderate supervision.

    + Strong organizational, verbal, and written communication skills.

    + Effective conflict resolution and negotiation abilities.

    Preferred Qualifications:

    + Previous experience conducting GLP audits.

    + Familiarity with toxicokinetic or bioanalytical study data.

     

    _*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

    \#LI-DNP

    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.