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/Complaints. The QA Compliance Specialist III - Deviations/CAPAs/Complaints, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. The Specialist will assist with the tracking and coordination and closure Deviations/CAPAs/Complaints.

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives.

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

Job Description

Essential Functions:

* Compliance Delivery

* Assist in remediation and closing of Deviations, CAPAs and Complaints which includes hosting a Quality Review Board

* Manage a 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.

* 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, such as Facilities, Materials Management, Quality Assurance, and 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 asn SME and process owner.

* 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 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.

* All other duties as assigned.

Required Skills & Abilities:

* Excellent written and oral communication skills.

* Excellent organizational, analytical, data review and report writing skills.

* Time management skills are essential as QA Compliance Specialist will be required 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 as well as communicate effectively both orally and in writing 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 multitask and easily prioritize work.

* Ability to work independently with little supervision.

* Proficient in Microsoft Excel, Word and PowerPoint.

* All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.

Working Conditions &

Physical Requirements:

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 including…