Overview
QA Analyst III, Day Shift (On-site in College Station, TX) Jobs in United States at FUJIFILM Diosynth Biotechnologies
Title: QA Analyst III, Day Shift (On-site in College Station, TX)
Company: FUJIFILM Diosynth Biotechnologies
Location: United States
***This position does support our site in College Station, TX and will require relocation to the area.
The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of 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.
Reports to Director, Quality Assurance/Senior Manager, Quality Assurance
Work Location College Station, TX (On-site at NCTM building)
Primary Responsibilities:
• 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
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 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
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.
• Assist with compliance related functions.
• All other duties as assigned.
Qualifications:
• High school or equivalent and 8+ years’ experience in Pharmaceutical or other regulated Industry.
• Associates Degree and 5+ years’ experience in Pharmaceutical or other regulated Industry.
• Bachelor’s degree and 3+ years’ experience in Pharmaceutical or other regulated Industry.
• Master’s Degree and 1+ years’ experience in Pharmaceutical or other regulated Industry.
• 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 your work.
• Ability to work independently with little supervision.
• Proficient in Microsoft Excel, Word and PowerPoint.
• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.
