Position Overview

Senior QA Analysts for FUJIFILM Diosynth Biotechnologies Texas LLC, College Station, TX.

Responsible for review and/or approval of basic and technical documentation, drafting and reviewing internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally for drug, biologics or vaccine products. Provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager. Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to: Standard Operating Procedures; Batch Production Records (completed and approval); Commissioning, qualification and validation protocols and reports; Deviation Reports; Corrective Action/Preventive Action Plans; Technical data review and approval; QC data review and approval; Drug Substance/Product Reports; and Trending QA data. Draft and review internal Quality policies, procedures, and reports. Perform inspection of final product containers and review and/or approval of executed process production batch records and data. Perform Quality audit functions to include but not limited to: Audit of lab notebooks; Audit of equipment logbooks; Review of vendor, supplier, contract laboratory audit questionnaires; and Lead vendor, supplier, contract laboratory and client audits. Identify process and Quality System improvement opportunities. Provide daily guidance for the 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; Promptly 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 and compliance related functions.

Job Description

Requirements:

Master's degree in Project Management, Biology, Chemistry, or related biology/pharmaceutical/engineering field and three years of experience as a QA Analyst or related occupation in quality assurance OR Bachelor's degree in Project Management, Biology, Chemistry, or related biology/pharmaceutical/engineering field and five of experience as a QA Analyst or related occupation in quality assurance.

Must possess three years of experience with a Master's and five years with Bachelor's in:
• Leading initial Quality Assurance on- the-floor assessments pertaining to real-time day- to- day manufacturing events including, process excursions, equipment alarms, and operator errors to ensure timely execution of impact and risk assessments that preserve batch integrity and product quality .
• cGMP regulations for the production of drug, biologics or vaccine products.
• Quality assurance in pharmaceutical or other regulated industry experience.
• Deviation investigations and CAPA (Corrective Action/ Preventive Action).
• Performing real-time review and approval of production batch records.
• Systems such as DeltaV , SAP, Veeva , TrackWise, and MasterControl platforms.

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