Visual Inspections Manager

• Lead and manage the manual and automated visual inspection program and inspection qualification processes.
  
• Provide guidance and visual inspection subject matter expertise with focus on start-up, execution, and maintenance. Coach and develop the Visual Inspection Team to ensure timely completion of projects at the expected results.
  
• Support all commissioning and qualification requirements.
  
• Assist in overall site operational readiness activities.
  
• Collaborate with cross functional teams to drive successful project completion and strong operationally centered results.
  
• Develop qualification kits and qualify operators.
  
• Execute new equipment and process qualifications.
• Determine appropriate classifications in rejected units.
  
• Develop and evaluate inspection parameters and techniques for new products.
  
• Provide continued optimization of parameters for existing products.
  
• Perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Visual Inspection.
  
• Identify corrective and preventative actions.
• Develop and approve standard operating procedures, specifications, and other required documentation.
  
• Implement manufacturing control strategy for automated visual inspection.
  
• Interact and coordinate with regulatory agencies during site inspections.
  
• Ensure operations meet the approved production plan requirements while minimizing costs and adhering to established quality limits, in accordance to with FDA, cGMP, ISO, and OSHA requirements.
  
• Develop performance metrics on business objectives. Ensure necessary changes to improve overall performance.
  
• Additional responsibilities as assigned.
  

Requirements

• Bachelors degree in science-related field.
• 7+ years of experience in a GMP FDA, cGMP, ISO, or other regulated production environments.
  
• 3+ years of managerial experience.
  
• Advanced experience with automated visual inspection systems.
  
• Advanced knowledge of Current Good Manufacturing Practices (cGMP), FDA, USP, OSHA, EPA, DEA; other regulatory requirements.
  
• Strong knowledge of Lean Six Sigma Tools and DMAIC problem solving approaches.
  
• Excellent communication and interpersonal skills.
  
• Strong technical aptitude and ability to guide and mentor junior team members.
  
• Strong time-management with the ability to prioritize and maintain multiple competing deadlines.
  
• Previous facility or start-up experience is a plus.
  
• Experience with highly automated equipment is preferred.
  
• Experience with combination products, device assembly, pharmaceutical packaging, and filling in aseptic environment is preferred.
  
• Equipment qualification and process validation experience is preferred.
  
• Previous experience with deviation and change management systems, including Veeva, is preferred.
  
• Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
  

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  
• 401(k) and 401(k) matching
  
• PTO, Sick Time, and Paid Holidays
  
• Education Assistance
  
• Pet Insurance
  
• Discounted rate at Anytime Fitness
  
• Financial Perks and Discounts