Quality Assurance Specialist II, Validation
3 days ago
FUJIFILM Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Specialist II, Validation to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and integrity of our products.
Key Responsibilities- Document Review and Approval: Review and approve basic and technical documentation, including Standard Operating Procedures, Analytical Methods, Disposition certificates, Batch Production Records, Corrective Action/Preventive Action Plans, QC Data review, Technical Data Review, and Drug Substance/Product Reports.
- Quality Policy and Procedure Development: Draft and review internal Quality policies and procedures to ensure compliance with regulatory requirements.
- Quality Audit Functions: Assist in and perform Quality audit functions, including audit of lab notebooks, audit of equipment logbooks, and identification of process and Quality System improvements.
- QA Liaison: Act as a QA liaison to internal departments and vendor/contract laboratory quality groups, and notify supervisors of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Education: Master's degree in a related science concentration with 1+ year of experience in cGMP supporting pharmaceutical or biotechnology products; OR Bachelor's degree in a related science concentration with 2+ years of experience in cGMP supporting pharmaceutical or biotechnology products; OR Associate's degree in a related science concentration with 4+ years of experience in a regulated industry, including 2+ years of experience in cGMP supporting pharmaceutical or biotechnology products; OR High school diploma or GED and 6+ years of experience in a regulated industry, including 2+ years of experience in cGMP supporting pharmaceutical or biotechnology products.
- Certifications: ASQ Certification preferred.
- Skills: 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 adapt to frequent and rapid changes in the work environment, ability to work independently and establish work priorities to meet targets and timelines, proficient in Microsoft Excel, Word, and PowerPoint.
- Regulatory Knowledge: Working knowledge of cGMP regulations for the production of drug, biologics, or vaccine products.
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