Basic Purpose/Function:

To assist the Quality assurance manager in all aspects of quality assurance services. To ensure that continuous improvement and compliance objectives are met. Verifying that finished goods, packaging, ingredients, and new products meet all established specifications and standards, maintain quality records and customer complaint system. Communicate and interact with customers.

Primary Duties and Responsibilities:

• Assure all process standards are safe and provide quality products to customers.
• Coordination and tracking of product quality review and disposition activities, ensuring all manufacturing processes are documented.
• Manage, schedule, and host the internal/external audits and report the results of audits to management.

• Conduct internal audits of PMC Biogenix departments, summarize the results of audits, and follow up to ensure corrective actions have been implemented.
• Support product regulations in maintaining regulatory documents and related customer support.

• Document Control Administrator - works with all departments in review, updating and maintaining production/maintenance/safety procedures to reflect ISO 9001 standards and distribution of required copies.

• Assists in conducting FDA validation of regulated processes.
• Assist in maintaining computer specifications and related quality data in Oracle or other associated software.
• Coaches plant employees on quality initiatives and audits to ensure compliance.
• Prepare and conduct training presentations when needed on Quality topics.
• Ensure that all communication with customers represents the company in a positive and professional manner.
• Enter, update, and maintain Complaint Resolution and Corrective Action System for all products and departments.
• Supplier Corrective Actions issues – update and maintain reported complaints against suppliers. Including issuance of claims for product damaged by vendor.
• Assist in document preparation for Annual/Semi-Annual Management Review meeting.
• Organize and maintain customer files including FDA related material.
• Maintain production records of NF and USP products, including review of such records in accordance with GMP procedures.
• Create new items, BOM, COA and product specifications in oracle.
• Maintain raw materials COA.
• Update and maintain logs on various quality projects throughout the plant as well as assist in assuring projects are completed/rejected based on findings [Ex. Quality Plans, Internal Audits, etc., Special Customer Specifications, New Products, Retest of products, Specification Changes, Internal Service Failures, Product Non-conformances, Documents of External Origin].
• All other duties as assigned.