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Quality System and Compliance Specialist
4 months ago
Scope: The Quality System and Compliance Specialist has a robust understanding of applicable CGMP regulations and standards and is able to apply company policies, directives, and procedures to ensure compliance of site operations and quality systems. The position advises Quality Management of compliance issues, conducts quality related activities of diverse scope, and implements associated actions. The Quality System and Compliance Specialist interacts with all areas and levels of the company to support the manufacturing, filling, inspection, and packaging operations for biologic products at Kedrion, Melville.
Main Responsibilities:
The Quality System and Compliance Specialist supports Quality and Compliance through various activities and may be assigned to one of the activities or combination of multiple activities:
- Maintain the Quality Customer Complaints system by tracking complaints received from the Kedrion US Complaints Customer Service, conducting related quality investigations, and initiating corrective actions as required per the investigation justification. Must understand and be able to use root cause and risk analysis methodology to ensure thoroughness of the customer complaint investigations and corrective actions.
- Maintain the Contract Manufacturing Organization (CMO) Ortho Diagnostics requests and notifications including non-conformance, change control and other tracking records and associated documentation that requires Quality Assurance management review and approval.
- Understand and support management of the Kedrion Quality and Compliance systems such as Change Control, CAPA, and Document Control by initiating and tracking relevant records.
- Support monitoring of Compendial changes (USP-NF Phr. EU.), implementation of compendial changes and regulatory notifications.
- Ensure site compliance with Global Standards by tracking implementation and subsequent revisions of Global Standards, site gap analysis of local procedures, and implementations of Global standards at the site.
- Support data collections and completion of Annual Product Review within required timeframe assigned to specific products and intermediates.
- Support batch record and logbook issuance as well as retention and archiving of quality and other site documentation.
- Support Internal Audits and Facility Surveillance Monitoring activities.
- Support Regulatory inspections and Customer Audits by working together with the Inspection team to ensure timely and accurate documentation is provided. Support regulatory submissions if applicable.
- Participate in interdepartmental project teams including development, deployment, and implementation of the company’s quality management systems.
- Perform other quality related activities, as assigned.
Knowledge, Skills, and Abilities
· Knowledge/be able to learn and maintain Kedrion Quality Systems including TW, MC, etc.
· Knowledge of Microsoft Office and e-mail required.
· Focus on delivering excellent customer service.
· Excellent communication skills both verbal and written.
· Problem solving skills, results oriented.
· Satisfactorily handles conflict situations.
Requirements:
· B.S. degree in science or equivalent with 5 years of pharmaceutical experience.
· Direct experience with biologics Quality Assurance or Manufacturing preferred.
· Plasma fractionation experience preferred.
· ASQ certification preferred.
Hours of Work:
- Position will be day shift, with flexibility needed to work off-shifts on occasion.
Other Requirements:
Travel may be required, less than 10%
