Senior Quality Assurance Analyst (GMP)

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.
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.
Summary: The Senior Quality Assurance (QA) Analyst, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.
They will also provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager.
External US: Essential Functions: Review and/or approve basic and technical documentation with minimal supervisory oversight.
Draft and review internal Quality policies, procedures and reports.
Perform inspection of final product containers and review and/or approval of executed process records and data.
Perform Quality audit functions.
Identify process and Quality System improvement opportunities.
Provide daily guidance for the compliance of the QA department to national and international standards and regulations.
Support Regulatory, client, and internal audits.
All other duties as assigned.
Required Skills & Abilities: Excellent written and oral communication skills.
Excellent organizational, analytical, data review and report writing skills.
Ability to set personal performance goals and provide input to departmental objectives.
Ability to multitask and easily prioritize your 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.
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.
Attendance is mandatory.
Qualifications: Master’s Degree with at least three (3) years of Pharmaceutical or other regulated Industry experience.
Bachelor’s Degree with at least five (5) years of Pharmaceutical or other regulated Industry experience.
Associate degree and at least seven (7) years of Pharmaceutical or other regulated Industry experience.
Preferred Qualifications: Certified Quality Auditor Degree in Biology or Chemistry 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.