QA Analyst II, Supplier Quality

Fujifilm - College Station, TX

Full-time

College Station, TX

Machinery Manufacturing

About the position

The Quality Assurance (QA) Compliance Analyst II, Supplier Quality at FUJIFILM Diosynth Biotechnologies is responsible for supporting the supplier quality program. This role involves ensuring that all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility. The position plays a critical role in maintaining compliance, conducting audits, and fostering a quality culture within the organization.

Responsibilities

• Serve as the QA representative to external suppliers.
• Support 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 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.
• Work collaboratively with site management to instill a ‘Quality Culture' by coaching in applying GMP Principles.
• Support client due diligence and Quality audits as well as regulatory inspections.
• Work with Quality management to implement and grow phase-appropriate quality systems for cGMP manufacturing.
• Handle supplier complaints, change notifications, and specification quality assurance approval.
• Serve as Subject Matter Expert for various SQA functions.

Requirements

• 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
• Associate's degree with 4 years of cGMP experience supporting pharmaceutical or biotechnology 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.
• Working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.

Nice-to-haves

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

Benefits

• Equal opportunity employer
• Affirmative action employer