QA Analyst I, Supplier Quality

Fujifilm - College Station, TX

Full-time - Entry Level

College Station, TX

Machinery Manufacturing

About the position

The Quality Assurance (QA) Analyst I, Supplier Quality is responsible for supporting the supplier quality program at FUJIFILM Diosynth Biotechnologies. This role involves ensuring that all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility. The analyst will work cross-functionally to uphold supplier quality requirements and standards, participate in audits, and handle supplier complaints, contributing to the overall quality assurance efforts within the organization.

Responsibilities

• 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.
• Act as the QA representative to external suppliers.
• Interface and coordinate with sister sites on supplier quality system, harmonization, and joint qualification.
• Maintain the approved supplier list.
• Process and 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 functions in the completion of site actions.
• 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.
• Handle supplier complaints, change notification management, and specification quality assurance approval.

Requirements

• High School diploma or equivalent with seven (7) years or more of Pharmaceutical or other Regulated Industry experience, or an Associate's Degree with three (3) years or more of experience, or a Bachelor's Degree.
• Working knowledge of cGMP regulations for the production of drugs, biologics, or vaccine products.
• 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.

Nice-to-haves

• Degree in Biology, Chemistry, or Engineering.
• Six Sigma Green/Black Belt certification.
• cGMP experience.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional development and growth.
• Supportive work environment that encourages innovation.