Quality Assurance Specialist III
About The Position
The Quality Assurance Specialist III is responsible for the review and approval of Quality System Records, including Deviations/CAPAs/Complaints, ensuring compliance with Fujifilm quality policies and site SOPs for regulatory compliance. This role involves assisting with the tracking, coordination, remediation, and closing of these records, as well as managing daily metrics for pending items to ensure timely closures. The specialist will perform quality oversight for deviations, CAPAs, and customer complaints, ensuring clear and concise root cause analysis and investigation write-ups. This includes conducting information gathering sessions with cross-functional departments and supporting client due diligence, quality audits, and regulatory inspections. The position also involves working with Quality management to implement and grow phase-appropriate quality systems for cGMP manufacturing and supporting other QA teams and functions. A key aspect is providing cGMP assistance to departments such as Facilities, Materials Management, Quality Assurance, and Validation, and promptly notifying Senior Management of potential quality or regulatory issues.
Requirements
- Master’s degree in Biology, Chemistry, Engineering or related field and one (1) year of experience as a quality assurance specialist or related occupation in quality assurance; OR Bachelors degree in Biology, Chemistry, Engineering or related field and three (3) year of experience as a quality assurance specialist or related occupation in quality assurance.
- Quality Assurance experience in Pharmaceutical or other regulated industry
- Experience presenting under Audit and Inspection
- Building and leading training content related to quality system records
- Using a digital Quality Management System platform
- Technical writing
- Previous experience operating in a position where cGMP regulations govern the production of drug, biologics or vaccine products
Responsibilities
- Review and approval of Quality System Records (e.g. Deviations/CAPAs/Complaints)
- Handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs
- Assist with the tracking and coordination and remediation and closing of Deviations/CAPAs/Complaints
- Responsible for daily metrics pertaining to pending deviations, CAPAs, customer & client complaints to ensure on time closures
- Perform deviation, CAPA, customer complaint quality oversight and write up of client complaints to ensure root cause analysis and write up of investigation are clear and concise
- Conduct timely information gathering sessions with cross-functional departments to obtain the required information and data to complete the review and closure of investigations
- Support client due diligence and Quality audits as well as regulatory inspections
- Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products
- Support client audit requests
- Ensure self, and team, have no overdue training, or site actions
- Support other QA teams and other functions in completion of site actions
- Provide cGMP assistance with cross-functional departments, such as Facilities, Materials Management, Quality Assurance and Validation
- Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
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What This Job Offers
Job Type
Full-time
Career Level
Senior
