QA Analyst (Quality Assurance Analyst) Senior

Fujifilm - College Station, TX

Full-time - Mid Level

College Station, TX

Machinery Manufacturing

About the position

The Senior Quality Assurance (QA) Analyst at FUJIFILM Diosynth Biotechnologies plays a crucial role in ensuring the quality and compliance of pharmaceutical products. This position operates under minimal supervision and is responsible for reviewing and approving both basic and technical documentation, which includes Standard Operating Procedures, Batch Production Records, and various quality-related reports. The analyst will also draft and review internal Quality policies and procedures, perform inspections of final product containers, and oversee the approval of executed process records and data. In addition to documentation review, the Senior QA Analyst will conduct Quality audit functions, which encompass auditing lab notebooks, equipment logbooks, and vendor audit questionnaires. They will lead audits for vendors, suppliers, and contract laboratories, ensuring that all processes align with national and international standards and regulations. The role requires identifying opportunities for process and Quality System improvements and providing daily guidance to ensure compliance within the QA department. The analyst will act as a liaison between internal departments and external client Quality groups, promptly notifying senior management of any potential quality or regulatory issues that could impact product quality or compliance. They will also assist with technical oversight and training for the QA team, ensuring that priority tasks are covered and escalating issues to Quality Management as necessary. This position is integral to maintaining the high standards expected in the pharmaceutical industry, contributing to the development of vaccines, cures, and gene therapies.

Responsibilities

• Review and/or approve basic and technical documentation with minimal supervisory oversight.
• Draft and review internal Quality policies, procedures, and reports.
• Perform inspection of final product containers and review and/or approval of executed process records and data.
• Conduct Quality audit functions, including audits of lab notebooks and equipment logbooks.
• Lead vendor, supplier, contract laboratory, and client audits.
• Identify process and Quality System improvement opportunities.
• Provide daily guidance for compliance of the QA department to national and international standards and regulations.
• Support Regulatory, client, and internal audits.
• Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Assist with technical oversight/training for the QA team.
• Assist with compliance-related functions.
• Ensure priority task coverage.
• Escalate any issues as identified to Quality Management and/or departmental Management as needed.

Requirements

• Masters Degree and 3+ years of Pharmaceutical or other regulated Industry experience.
• Bachelors Degree and 5+ years of Pharmaceutical or other regulated Industry experience.
• Associates degree and 7+ years of Pharmaceutical or other regulated Industry experience.
• Certified Quality Auditor preferred.
• Degree in Biology or Chemistry preferred.
• 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

• Experience in a leadership role within Quality Assurance.
• Familiarity with regulatory submissions and compliance processes.

Benefits

• Health insurance coverage.
• 401k retirement savings plan.
• Paid holidays and vacation time.
• Professional development opportunities.
• Flexible scheduling options.