QA Analyst II, Supplier Quality - Fujifilm

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 Quality Assurance (QA) Compliance Analyst II, Supplier Quality will be responsible for supporting the supplier quality program.  The SQA Specialist II will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.

Essential Functions:

• Compliance
• QA representative to external suppliers
• Support to the organization in conducting internal audits and hosting audits/inspections.
• Interface and coordinate with sister sites on supplier quality system, harmonization, and joint qualification
• Maintain approved supplier list
• Process/track complaints to suppliers
• Develop and issue weekly and monthly metric reporting on supplier performance
• Provide audit support when needed
• Participate in Material Review Board (MRB) review of nonconforming product; recommend disposition and corrective action.
• Leadership
• Work collaboratively with site management to instill a ‘Quality Culture’ by coaching in applying GMP Principles including the underlying rationale of those principles.
• 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.
• Supplier complaint handling, change notification management and specification quality assurance approval
• Serve as Subject Matter Expert for various SQA functions
• 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 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 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.

Qualifications:

• Master’s degree in a science-related field with 1 year of cGMP experience supporting pharmaceutical or biotechnology products; OR
• Bachelor’s degree in a science-related field with 2 years of cGMP experience supporting pharmaceutical or biotechnology products; OR
• Associates degree with 4 years of cGMP experience supporting pharmaceutical or biotechnology products.

Preferred Qualifications:

• Degree in Biology, Chemistry or Engineering
• Six Sigma Green/Black Belt cGMP experience.
• ASQ Quality Auditor Certification
• cGMP experience

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.