Position Overview
Summary:
The Quality Assurance (QA)SpecialistIII –Deviations/CAPAs/Complaints,will be responsible forthe review and approval ofDeviations/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. TheSpecialistwill assist with thetracking andcoordination and closureDeviations/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: https://www.fujifilm.com/us/en/about/region/careers
Job Description
Essential Functions:
- Assist in remediation and closing of Deviations, CAPAs and Complaintswhich 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.
- Supportclient due diligence and Quality audits as well as regulatory inspectionsasn SME and process owner.
- Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMPmanufacturing ofpre-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.
- ProvidecGMPassistancewith cross-functional departments,such as Facilities, Materials Management, Quality Assuranceand Validation.
- Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- All other duties asassigned.
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 tomultitask and easily prioritize work.
- Ability to work independentlywith little supervision.
- Proficient in Microsoft Excel, Word and PowerPoint.
- All candidatesmusthavea working knowledgeof cGMP regulationsfor the production ofdrug, 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 laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
- Lifting upto 25 pounds on occasion.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- 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.
Qualifications:
- High school or equivalent: 8 years or more experience in Pharmaceutical or other regulated Industry.
- Associates Degree: 5 years or more experience in Pharmaceutical or other regulated Industry.
- Bachelor’s degree: 3 years or more experience in Pharmaceutical or other regulated Industry.
- Master’s Degree: 1 year or more experience in Pharmaceutical or other regulated Industry working in Audit and Inspection.
Preferred Qualifications:
- Degree inBiology, Chemistryor Engineering
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).
