Assoc Dir, Quality Control (Microbiology)

Company: Aesculap, Inc.
Location: Irvine
Posted on: January 22, 2023

Job Description:

Overview
About B. Braun -
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap - and CAPS -.
Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise - philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
Responsibilities
Position Summary:
Site Head of Quality Microbiology organization, provides leadership to Microbiology QC, QC in process control and Stability groups responsible for providing QC technical expertise, oversight, and testing to support new product development, regulatory submissions, sustaining projects, and release of commercial products. Manages staff of approximately 50 Micro Associates. - Site Subject Matter Expert on Microbiology and physical testing, method and process validation, and regulatory compliance requirements for pharmaceutical manufacturing. - Provide QC technical and tactical support for the B. Braun manufacturing facilities to ensure compliance with cGMP and regulatory requirements both internally and externally. - Plan, organize and manage the activities to ensure timely completion of group's tasks. - Interact with FDA and other regulatory authorities as Subject Matter Expert for Irvine Quality Microbiology processes, procedures and analytical methods. Manage the development and implementation of related programs to maximize efficiencies of staff, testing and budgetary resources necessary to support the company goals while complying with regulatory requirements.
Responsibilities: Essential Duties

• 
  
• -Manages the quality control activities of an organization.
  
• Assists with overseeing tasks associated with inspecting and testing products.
  
• Ensures that products or services meet quality standards and develops corrective action when needed.
  
• Develops, implements and assesses processes and policies designed to test products and services.
  
• Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
  
• Enforces regulatory compliance.
  
• Conducts visual and physical inspections of company products and materials.
  
• Monitors the performance of the quality control staff, ensuring that the quality control department meets organizational objectives.
  
  The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.General:It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
  Expertise: Knowledge & Skills
  
  • 
    
  • Requires breadth of professional field and industry knowledge.
    
  • Ability to integrate critical information and champion advanced strategies/concepts through the organization.
    
  • Drives development of advanced technologies, principles and processes.
    
  • Manages entry to intermediate level employees of a department or a function with 1 or 2 sections.
    
  • Ensures budgets, schedules, and performance requirements are met.
    
  • Judgement is required in resolving complex problems based on experience.
    
  • Contacts are primarily with department supervisors, leads, subordinates, and peers.
    
  • Occasional contact with external contractors/vendors.
    
    Target Based Range$139,550 - $169,440
    Qualifications
    Expertise: Qualifications -Education/Experience/Training/Etc
    Required:
    
    • 
      
    • Bachelor's degree required, Master's degree preferred.
      
    • 10-12 years related experience required.
      
    • Applicable industry/professional certification preferred.
      
    • Regular and predictable attendance
      
    • Occasional business travel required, Valid driver's license and passport
      
      While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
      B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
      Through its "Sharing Expertise -" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
      Additional Information
      Responsibilities: Other Duties:
      The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
      Physical Demands:
      While performing the duties of this job, the employee is expected to:
      
      • 
        
      • Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
        
        Lifting, Carrying, Pushing, Pulling and Reaching:
        
        • 
          
        • Occasionally:Reaching upward and downward, Push/pull
          
        • Frequently:Stand, Sit
          
        • Constantly:N/A
          
          Activities:
          
          • 
            
          • Occasionally:Push/pull, Reaching upward and downward, Walking
            
          • Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing, Talking - ordinary, loud/quick
            
          • Constantly:N/A
            
            Environmental Conditions:
            
            • 
              
            • Occasionally:N/A
              
            • Frequently:N/A
              
            • Constantly:N/A
              
              Work Environment:
              The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
              
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              • Noise Intensity:Moderate
                
              • Occasionally:N/A
                
              • Frequently:Office environment, Production/manufacturing environment, Lab environment
                
              • Constantly:N/A
                
                What We Offer B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. - Through its "Sharing Expertise -" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
                Notices
                Equal Opportunity Employer Veterans/Disabled

Keywords: Aesculap, Inc., Irvine , Assoc Dir, Quality Control (Microbiology), Other , Irvine, California