QA Specialist III - Deviations​/CAPA's​/Complaints

Position Overview

Summary:

The Quality Assurance (QA) Specialist III – Deviations/CAPAs/Complaints will be responsible for the review and approval of Deviations, CAPAs, and Complaints. The QA Compliance Specialist III will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance, and will assist with the tracking, coordination, and closure of Deviations, CAPAs, and Complaints.

• Compliance Delivery
• Assist in remediation and closing of Deviations, CAPAs and Complaints, including hosting a Quality Review Board
• Manage 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 investigation are clear and concise
• Perform qualification review for investigator and quality colleagues
• Perform training for new investigators and QA reviewers
• Conduct timely information gathering sessions with cross‑functional departments (Facilities, Materials Management, Quality Assurance, Validation) to obtain required information and data to complete the review and closure of an investigation
• Support client due‑diligence and quality audits as well as regulatory inspections as SME and process owner
• Work with Quality management to implement and grow phase‑appropriate quality systems that enable cGMP manufacturing of pre‑clinical to commercial products
• Support client audit requests
• Ensure no overdue training or site actions; support other QA teams and functions in completion of site actions
• Provide cGMP assistance with cross‑functional departments (Facilities, Materials Management, Quality Assurance, Validation)
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• All other duties as assigned

• Excellent written and oral communication skills
• Excellent organizational, analytical, data review and report writing skills
• Time‑management skills essential to assist with and manage multiple Deviations, CAPAs, or Complaints and adhere to assigned due dates
• Ability to respond effectively to sensitive inquiries, client inquiries or complaints and communicate effectively with management, peers and individuals
• Ability to work effectively, exhibit a professional manner and establish constructive working relationships
• Ability to set personal performance goals and provide input to departmental objectives
• Ability to multithread and prioritize work easily
• Ability to work independently with little supervision
• Proficient in Microsoft Excel, Word and Power Point
• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching
• Ability to sit for long periods to work on a computer
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing (lab scrubs), cleanroom (ISO 8 to ISO
  5) gowning material and appropriate shoes required in most areas associated with this position
• Lifting up to 25 pounds on occasion
• Use hand‑eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment
• Must be willing to work flexible hours
• Ability to work weekends and off‑shift hours, as needed to support manufacturing activities
• Must be willing to travel occasionally, as needed
• Attendance is mandatory

• High school or equivalent: 8 years or more experience in…