Job description
Overview:
The Quality Compliance Associate will support Quality Compliance objectives to ensure compliance to state, federal and other requirements.
Responsibilities:
- 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.
- Assist with planning, conducting and documenting internal audits. 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.
- 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.
- 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%, domestic and international
Bachelor's (B.S.) degree is required, preferably in a science related field. Zero to three years related experience and/or auditing training is required.
ASQ CQA certification preferably
ASQ CQA certification preferably
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