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 at Fujifilm is a pivotal role that supports the supplier quality program within the organization. This position is essential for ensuring that all suppliers of raw materials, consumables, and GMP services are qualified before their use in the facility. The QA Analyst will be responsible for adhering to Fujifilm Diosynth procedures and regulatory requirements for supplier quality management. This includes supporting supplier audit preparations, processing supplier complaints, and assisting with client audit requests by gathering necessary site documentation. The role also involves acting as a QA representative to external suppliers and coordinating with sister sites on supplier quality systems, ensuring harmonization and joint qualification of suppliers. In addition to compliance tasks, the QA Analyst will maintain an approved supplier list, process and track complaints to suppliers, and develop weekly and monthly metric reports on supplier performance. The position requires participation in Material Review Board (MRB) reviews of nonconforming products, recommending appropriate dispositions and corrective actions. The QA Analyst will also support other QA teams and functions in completing site actions, ensuring that there are no overdue training or site actions. The role is not limited to compliance; it also involves new business growth. The QA Analyst will work cross-functionally with various areas within the organization to uphold supplier quality requirements and standards. This includes supporting client due diligence, quality audits, and regulatory inspections. The QA Analyst will collaborate with Quality management to implement and grow phase-appropriate quality systems that enable cGMP manufacturing of products from pre-clinical to commercial stages. Additionally, the role encompasses supplier complaint handling, change notification management, and specification quality assurance approval, along with other duties as assigned.

Responsibilities

• Support the supplier quality program by ensuring all suppliers are qualified prior to use.
• Adhere to Fujifilm Diosynth procedures and regulatory requirements for supplier quality management.
• Assist with supplier audit preparations and post-audit responses.
• Process supplier complaints and change notifications.
• Gather site documentation for client audit requests.
• Act as QA representative to external suppliers.
• Interface and coordinate with sister sites on supplier quality systems.
• Maintain the approved supplier list and process/track complaints to suppliers.
• Develop and issue weekly and monthly metric reporting on supplier performance.
• Provide audit support when needed and participate in Material Review Board (MRB) reviews of nonconforming products.
• Support other QA teams and functions in completing site actions.
• Work cross-functionally to uphold supplier quality requirements and standards.
• Support client due diligence and quality audits as well as regulatory inspections.
• Implement and grow phase-appropriate quality systems for cGMP manufacturing.

Requirements

• High School diploma or GED with seven years of experience in Pharmaceutical or other Regulated Industry, or an Associate's Degree with three years 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.
• Strong organizational, analytical, data review, and report writing skills.
• Ability to set personal performance goals and contribute to departmental objectives.
• Ability to multitask and prioritize work effectively.
• Proficient in Microsoft Excel, Word, and PowerPoint.

Nice-to-haves

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

Benefits

• Competitive salary range of $75.1K - $95.1K per year.
• Opportunities for professional development and growth within the company.
• A culture that promotes passion, energy, and drive among employees.