What are the responsibilities and job description for the Quality Compliance Specialist position at LTS Nasal and Sterile Drug Products?
Compile data and generate Annual Product Reviews/Product Quality Reviews. Adhere to timelines outlined in pertinent standard operating procedures (SOPs) and communicate due date to respective departments and upper management. Provide the final report to clients.
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 Renaissance'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.
Is able to travel a minimum of 30%
Performs other duties as assigned.
Salary.com Estimation for Quality Compliance Specialist in Lakewood, NJ
$67,125 to $82,816
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