Our client, a leading pharmaceutical company, is hiring a QA Shop Floor Specialist on a contract basis.
• Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities, make improvements and resolve issues
• Perform QA shop floor activities, focused on Manufacturing Operations
• Ensure compliance with applicable procedures and production requirements
• Perform real-time review of manufacturing records. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions.
• Seeks management guidance on complex issues.
• Develops and revise procedures.
Knowledge & Skills:
• Must be action-oriented and skilled in decision-making, building relationships, problem-solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
• Understands continuous improvement and improves efficiency and productivity within the group or project
• Builds relationships internally within and with cross-functional teams. Contributes to goals within the workgroup
• Ability to direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
• Possess sound knowledge of FDA-regulated cGMP Quality Manufacturing operations and processes and global cGMP requirements
• Must be skilled in planning and organizing, decision-making, and building relationships
• Knowledge of quality processes, including material disposition, material storage, and handling requirements, change control, product complaints, deviations, investigations, and CAPA management
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Possess an independent mindset. Work is self-directed
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision
• Confident in making decisions for non-routine issue
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
• Able to prepare written communications and communicate problems to management with clarity and accuracy
• Excellent verbal and written communication skills
• High School Diploma/GED
• At least six months of experience working in a GMP Aseptic manufacturing environment
• Experience in FDA-regulated cGMP Quality Manufacturing operations and processes.
• Available for weekend and off-shift hours
• Bachelors Degree preferred
• 5 years of cGMP Quality Manufacturing operations and processes work experience.
• Quality Assurance Shop Floor Manufacturing roles/experience highly desired (Ex. Quality Operations, In-process QA, IPQA, Quality Inspectors).