Sr QA Specialist

Kite Pharma • Frederick, MD

6d • $123,930 - $160,380 • Onsite

About The Position

This position requires: The ability to work on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences. Exercises judgment to determine appropriate action with minimal supervision. Ability to handle pressure and fast decision making.

Responsibilities (included but not limited to):
Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences. Exercises judgment within established procedures and practices to determine appropriate action with minimal supervision. Act as a mentor to QA junior staff. Manages the daily workflow of the QA Tech services team. Develops and Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Conducts or acts as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products, and performs QA review and approval of complex deviations and CAPAs. Provide QA oversight to deviations, OOS investigations, Laboratory Investigations, CAPAs, Effectiveness Checks and Change Controls. Knowledgeable in Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial. Support the development of Risk Management documents using tools such Failure Mode Effects Analysis (FMEA), etc. Uses/Develops KPI’s to identify and solve problems within the quality process. Identifies deviations from approved procedures and processes, evaluates impact assessments and develops solutions for complex problems. Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed. Assists with external audits/inspection processes as required, and acts as an SME for QA procedures and processes during inspections and audits, supporting implementation of corrective actions as agreed. Interfaces with external stakeholders to address documentation and compliance issues. Leads QA projects or contributes to cross functional projects using Lean concepts. Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences. Provides support to incoming escalations from various stakeholders, ensuring all immediate actions are taken and a path forward established. These duties can be delegated to designated deputies of a satisfactory qualification level as needed. Additional duties as assigned.

Requirements

• Proficient in GMPs and/or GLPs.
• Proficient in application of QA principles, concepts, industry practices, and standards.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Has proven analytical and conceptual skills.
• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates working knowledge and good proficiency in Microsoft Office applications.
• 7+ years of relevant experience in a GMP environment related field and a BS/BA. OR 5+ years of relevant experience and a MS.

Nice To Haves

• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
• Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.

Responsibilities

• Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.
• Exercises judgment within established procedures and practices to determine appropriate action with minimal supervision.
• Act as a mentor to QA junior staff.
• Manages the daily workflow of the QA Tech services team.
• Develops and Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Conducts or acts as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products, and performs QA review and approval of complex deviations and CAPAs.
• Provide QA oversight to deviations, OOS investigations, Laboratory Investigations, CAPAs, Effectiveness Checks and Change Controls.
• Support the development of Risk Management documents using tools such Failure Mode Effects Analysis (FMEA), etc.
• Uses/Develops KPI’s to identify and solve problems within the quality process.
• Identifies deviations from approved procedures and processes, evaluates impact assessments and develops solutions for complex problems.
• Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
• Assists with external audits/inspection processes as required, and acts as an SME for QA procedures and processes during inspections and audits, supporting implementation of corrective actions as agreed.
• Interfaces with external stakeholders to address documentation and compliance issues.
• Leads QA projects or contributes to cross functional projects using Lean concepts.
• Provides support to incoming escalations from various stakeholders, ensuring all immediate actions are taken and a path forward established.
• Additional duties as assigned.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Senior