QA Specialist III, Deviations/CAPAs/Complaints

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.

External US

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

The Quality Assurance 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.

Reports to Manager/Senior Manager, Quality Assurance Compliance

Work Location College Station, TX

Primary Responsibilities:

Compliance Delivery

Assist in remediation and closing of Deviations, CAPAs and Complaints.

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.

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.

New Business Growth

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.

Compliance

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.

All other duties as assigned.

Qualifications:

Master’s Degree and 1+ year of experience in Pharmaceutical or other regulated Industry.

Bachelor’s degree and 3+ years of experience in Pharmaceutical or other regulated Industry.

Associates Degree and 5+ years of experience in Pharmaceutical or other regulated Industry.

High school or equivalent and 8+ years of experience in Pharmaceutical or other regulated Industry.

Degree in Biology, Chemistry or Engineering preferred.

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.

Role model for company core values of trust, delighting our customers, Gemba, and Genki.

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 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 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.

Attendance is mandatory.

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3500.

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.