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Quality Compliance Associate Specialist

Company: Renaissance Pharmaceuticals
Location: Lakewood
Posted on: December 2, 2019

Job Description:

Overview

The Quality Compliance Associate will support Quality Compliance objectives to ensure compliance to state, federal and other requirements.

Responsibilities

  • Plan, conduct and document internal audits. Evaluate findings and report these to the respective department and upper management. Assure implementation of any resulting corrective action plans. Use the internal audit program to assess the level of DPT's compliance with applicable cGMP, QSR and pertinent standard operating procedures (SOPs).
  • Plan, conduct and document external audits (Raw Materials, Contract Laboratory, Sterilization facilities, etc.). Evaluate findings and report these to the respective companies and Renaissance management. Assure implementation of any resulting corrective action plans. Use the internal audit program to assess the level of Renaissance's compliance with applicable cGMP, QSR and pertinent standard operating procedures (SOPs).
  • Assist with on-site cGMP audits performed by, or on behalf of, clients and potential clients. Represent Renaissance Quality Systems and facilitate interactions between clients and Renaissance personnel during the audit. Assist with management of observations and corrective actions in Trackwise.
  • Manage and prepare client submission documents retrieved from supporting departments and assist in responding to deficiency letters received from agency.
  • Represent Lakewood Quality Compliance on client conference calls for submission readiness and support.
  • Support upper management as necessary in preparation for, during and following regulatory agency inspections.
  • Maintain knowledge of cGMP (US/EU) and company operating procedures and policies.
  • Performs other duties as assigned.
    Is able to travel a minimum of 30%

    Qualifications

    Bachelor's (B.S.) degree is required. A minimum of four years related experience and/or training is required.

    ASQ CQA & or RAC certification preferably PI115906969

Keywords: Renaissance Pharmaceuticals, Lakewood , Quality Compliance Associate Specialist, Other , Lakewood, New Jersey

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