Quality Assurance Engineer
AssistIQ
Senior QA Analyst, Analytical
FUJIFILM Corporation
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Review and/or approve basic and technical documentation including SOPs, batch production records, commissioning/qualification/validation protocols and reports, deviation reports, CAPA plans, technical and QC data, drug substance/product reports and QA trending data
- Draft and review internal Quality policies, procedures and reports
- Perform inspection of final product containers and review/approve executed process records and data
- Perform Quality audit functions (lab notebooks, equipment logbooks, vendor/supplier/contract laboratory audit questionnaires)
- Lead vendor, supplier, contract laboratory and client audits
- Identify process and Quality System improvement opportunities
- Provide daily guidance for QA department compliance to national and international standards and regulations
- Support Regulatory, client, and internal audits and act as QA liaison to internal departments and external client/vendor quality groups
- Promptly notify Senior Management of potential quality or regulatory issues
- Assist with technical oversight/training for the QA team and compliance related functions
- Ensure priority task coverage, escalate issues to Quality Management as needed
- Perform other duties as assigned
Requirements
- Master’s Degree and 3+ years of Pharmaceutical or other regulated Industry experience
- Bachelor’s Degree and 5+ years of Pharmaceutical or other regulated Industry experience
- Associate’s 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
- Physical requirements: prolonged standing, some bending, stooping, and stretching; lifting up to 25 pounds; manual dexterity to operate office equipment; attendance mandatory
