Sr. Specialist, QA Incoming Materials

Quality Assurance Incoming Material Disposition Senior Specialist

The Quality Assurance Incoming Material Disposition Senior Specialist is responsible for coordinating the receipt of deliverables to support the disposition of incoming materials such as consumables and raw materials at the RayzeBio Indianapolis, IN facility. This position will perform review of the disposition deliverables to support disposition of materials and batches within the inventory management systems and assure materials comply with all RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).

The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, and material disposition.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

1. Inspects consumables and raw materials per Standard Operating Procedures
2. Build and maintain cross functional relationships to improve processes and resolve issues.
3. Performs Quality Assurance review of documentation to support disposition of incoming materials.
4. Works closely with supply chain and manufacturing with regards to discrepancy reporting, investigations and CAPAs associated with nonconforming material as well as the incoming material process.
5. Drafts, revises, and approves procedural documents and material specifications.
6. Performs review for department SOPs and Material Specification Documents.
7. Supports warehouse personnel with concerns/issues with received material.
8. Participates in Master Data management and supports master data for incoming materials.
9. Leads the Indianapolis site Material Review Board.
10. Works with a cross functional team to process Supplier Change Notifications and determine appropriate actions needed.
11. Responsible for the Supplier Complaint (SCAR) process for non-conforming material.
12. Coordinates with internal and external stakeholders to troubleshoot issues when required.
13. Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation.
14. Identify and report discrepancies from required work practices or procedures to management.
15. Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
16. Participate as requested in the response team for audits and inspections by health authorities.

Education and Experience

• BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred
• Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry.
• Experience with an Enterprise Resource Planning (ERP) system such as SAP is preferred.
• Experience working with incoming material release is preferred.
• Experience working with FDA or other regulatory authorities is preferred.

Skills and Qualifications

• Expertise in GMP, Quality, and material disposition
• Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
• Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management
• Team player who can work independently to achieve objectives in a fast-paced environment
• Excellent verbal and written communication skills.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.

Work Environment

The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends.

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