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Responsibilities

• Provides leadership, direction, and work hands-on in performing Quality functions including Incoming Inspection & Release, In-Process QA, Label Control, and Material Disposition.
• Monitors day-to-day manufacturing activities to assure production processes are in compliance with and followed as per the FDA guidelines, written standard operating procedures, and company policies
• Supervisory oversight of the quality team.
• Ensures raw materials used in the production of products are from qualified/approved vendors and meet internal quality testing specifications.
• Advises other departments about quality assurance issues that impact their realm of responsibility.
• All phases of documentation review and approval, including the creation of standard operating procedures for the Quality Assurance Department.
• Administers the Hydrox Investigation/CAPA program including final approval of all reports.
• Performs data analysis investigation of trends for root cause analysis, creating corrective/preventive actions, and ensuring the effectiveness of the actions for products.
• Creates standard operating procedures to ensure quality assurance compliance with current good manufacturing practices.
• Seek efficiency improvements in productivity and quality without compromising the FDA regulatory and compliance standards.
• Immediately communicate to management any issues or problems potentially impacting products, processes, and/or any activities for the organization.
• Interface with other departments to ensure information is communicated to these department heads concerning quality matters in a timely and complete fashion.
• Participates in audits conducted by regulatory agencies and consultants.
• Assists the VP of Quality in developing and implementing systems, evaluating procedures, plans and policies to ensure product integrity and compliance with the current FDA guidance.
  

Requirements

• B.S. / B.A. in Science-related discipline with experience in a pharmaceutical/Food manufacturing organization.
• Thorough understanding of FDA cGMP regulations and experience in handling Regulatory inspections.
• Knowledge of pharmaceutical formulation and manufacturing processes.
• Minimum of 3years of supervisory or management experience in pharmaceutical/Food quality assurance.
• Versed in the regulatory requirements (cGMP) of the pharmaceutical industry, and will have demonstrated strength in problem solving and resolution.
• Must have proven interpersonal skills, and be able to direct the activities of subordinates.
• Able to perform statistical analysis in developing test levels and in performing investigations. Knowledge of Six Sigma Green Belt and lean tools.
• Excellent problem-solving aptitude, communication, and multi-tasking skills.
• Excellent verbal and written communication skills.
  

Benefits

Blue Bix