Quality Assurance Supervisor

As the Quality Assurance Supervisor with Ecolab, you will perform quality assurance functions supporting the new King of Prussia, Pa manufacturing facility with specific areas of focus including change control, regulatory compliance, records retention, and document control. As the QA Supervisor you will follow quality control guidelines and procedures to ensure that raw materials and finished goods comply with engineering and product specifications. You will lead and coach technicians in conducting quality assurance tests to ensure products meet established specifications.

What You Will Do:

• Training in systems/process and auditing/oversight to ensure alignment with API (Active Pharmaceutical Ingredient) GMP regulations, ISO 9001, and customer requirements.
• Acts as a Regulatory Compliance reviewer to ensure changes potentially impacting registered details (e.g. DMF's) are fully assessed through their proposal, execution, and implementation in alignment with the Regulatory Affairs function, customers, and regulators.
• Ensures completeness of documentation and applies A.L.C.O.A. (Attributable, Legible, Contemporaneous, Original, and Accurate) principles.
• Generates and tracks customer communications related to changes, works with commercial and regulatory teams to ensure proper communication.
• Understands regulatory dossier change processes.
• Assist with Quality Management System (QMS) training.
• Quality System oversight, metrics and improvements including vendor monitoring, change controls, CAPA, escalation and risk management.

Basic Qualifications:

• Bachelor's degree in science such as Chemistry, Biochemistry, Chemical Engineering, or related scientific field.
• 5 years' experience in Pharmaceuticals/GMP supporting quality (QA/QC) manufacturing.
• Experience with ISO 9001 or ISO 13485 Quality Management Systems.
• Clean room gowning experience required.
• Experience with ETQ, Trackwise, Veeva, SAP, Open Lab or ChemStation.

Preferred Qualifications:

• 3 years' experience as a Quality Supervisor

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