Quality Lab Associate

Job Responsibilities

• Determine scope, product impact, root cause, and corrective actions for deviations from manufacturing procedures.
• Conduct personnel interviews to ascertain the root cause of deviations.
• Foster collaborative relationships focused on high-quality investigations and meaningful corrective actions.
• Set up and facilitate meetings with cross-functional teams.
• Close deviations in a timely manner to meet business and compliance needs.
• Work with minimal supervision to drive deviations to closure.
• Collaborate with Subject Matter Experts and Quality Approvers to define the breadth and scope of investigations.
• Implement corrective and preventive actions, complete trending analysis, and recommend product disposition.
• Present and defend investigations during regulatory inspections, as required.
• Sustain a clean and safe work area using 6S principles.
• Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs), and Current Good Manufacturing Practices (cGMP).
  
  

Knowledge, Skills, And Abilities

• Strong communication and project management skills.
• Thorough understanding of pharmaceutical manufacturing processes and equipment, preferably parenteral solutions, and cGMPs.
• Excellent analysis, troubleshooting, and investigation skills.
• Ability to articulate complex issues clearly in written reports for informed decision-making.
• Ability to interact with and influence others at various levels in multiple departments.
• Proficient in understanding verbal and written safety and quality instructions.
  
  

Required Education And Experience

• Bachelor’s degree in science or engineering; advanced degree in life sciences, physical sciences, or engineering preferred.
• 2-3 years of experience in root cause evaluation, interpreting regulations, and quality systems.
• Minimum of 5-8 years of experience in Manufacturing Operations and/or Quality, or a related field in the medical products industry.
  
  

Other Duties as Assigned

Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties and responsibilities may change at any time with or without notice. Overtime may be required as necessary.