Fujifilm - College Station, TX

posted 2 months ago

Full-time - Mid Level
College Station, TX
Machinery Manufacturing

About the position

The Quality Assurance (QA) Compliance Analyst II, Supplier Quality at FUJIFILM Diosynth Biotechnologies plays a crucial role in supporting the supplier quality program. This position is responsible for ensuring that all suppliers of raw materials, consumables, and GMP services are qualified before their use within the facility. The QA Analyst will act as a representative to external suppliers, providing essential support to the organization in conducting internal audits and hosting audits or inspections. This role requires interfacing and coordinating with sister sites on supplier quality systems, harmonization, and joint qualification efforts. Additionally, the QA Analyst will maintain an approved supplier list, process and track complaints to suppliers, and develop and issue weekly and monthly metric reports on supplier performance. The position also involves providing audit support as needed and participating in Material Review Board (MRB) reviews of nonconforming products, recommending appropriate dispositions and corrective actions. In terms of leadership, the QA Analyst will work collaboratively with site management to instill a ‘Quality Culture’ by coaching staff in applying Good Manufacturing Practices (GMP) principles, including the underlying rationale of those principles. The role also supports new business growth by assisting with client due diligence, quality audits, and regulatory inspections. The QA Analyst will work with quality management to implement and grow phase-appropriate quality systems that enable cGMP manufacturing of products from pre-clinical to commercial stages. This includes handling supplier complaints, managing change notifications, and approving specifications for quality assurance. The QA Analyst will serve as a Subject Matter Expert for various Supplier Quality Assurance (SQA) functions and will perform all other duties as assigned.

Responsibilities

  • Support the supplier quality program by ensuring all suppliers are qualified prior to use.
  • Act as QA representative to external suppliers.
  • Conduct internal audits and host audits/inspections.
  • Interface and coordinate with sister sites on supplier quality systems and harmonization.
  • Maintain the approved supplier list and process/track complaints to suppliers.
  • Develop and issue weekly and monthly metric reports on supplier performance.
  • Provide audit support when needed and participate in MRB reviews of nonconforming products.
  • Work collaboratively with site management to instill a ‘Quality Culture’ by coaching in GMP principles.
  • Support client due diligence and quality audits as well as regulatory inspections.
  • 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
  • Associates 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 prioritize work effectively.
  • 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 certification.
  • ASQ Quality Auditor Certification.

Benefits

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