QA Analyst I, Supplier Quality

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

External US

Essential Functions:

• Compliance
• Adhere to Fujifilm Diosynth procedures and regulatory requirements for supplier quality management
• Support supplier audit preparations and post-audit responses, process supplier complaints and change notifications, assist client audit requests with site documentation gathering.
• QA representative to external suppliers
• 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.
• Ensure no overdue training, or site actions. Support other QA teams and other functions in the completion of site actions.
• New Business Growth
• Work cross-functionally with various areas within the organization to uphold supplier quality requirements and standards.
• 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
• 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