Quality Assurance Specialist III

Fujifilm•College Station, TX

2d•$65,000 - $88,230•Onsite

About The Position

Quality Assurance Specialist III for FUJIFILM Diosynth Biotechnologies Texas, LLC. Responsible for the review and approval of Quality System Records (e.g. Deviations/CAPAs/ Complaints) and will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. 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.

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.
One year of experience with Masters, or three years of experience with Bachelors with the following: 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 to ensure regulatory compliance
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