Visual Inspection Supervisor

Company: LSNE Contract Manufacturing
Location: Madison
Posted on: August 7, 2022

Job Description:

Job DescriptionThrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement. If this describes you, then look no further than LSNE. We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices. Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors. We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!JOB SUMMARY The Supervisor of Visual Inspection reports directly to the Manufacturing Manager LSNE-Madison. Responsible for supervising a team(s) of inspection technicians. Responsible for maintaining timely product inspection, documentation and bulk packing of sterile clinical and commercial products following cGMP's and in-house SOPs.JOB DUTIES

• Provides technical support, training and leadership to Visual Inspection Technicians
• Creates training modules, and performs new employee training
• Oversees areas with the responsibility of examining materials for quality, defects and planning of work
• Early detection and troubleshooting of problems arising on the line to prevent downtime
• Assist and or performs investigations, and resolves deviations associated to Visual Inspection process
• Manages, creates, plans and maintains metrics relating to defect rate, inspection throughput, and on time and right first time delivery
• Ensures visual inspection process and operator qualification process maintains compliance to applicable regulatory markets
• As needed participates in audits by customer and regulatory bodies as the Visual Inspection SME
• Increase efficiency and productivity by promoting systems, training, and proper record keeping
• Maintains compliance of company policies, safety standards, quality specifications and regulatory requirements
• Development of Visual Inspection team through individual reviews, goals and objectivesEDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE
  • AS/BS degree in related field is highly preferred. Relevant experience in sterile product visual inspection 4+ years
  • At least 5 years' experience in a supervisory role or 8 in a lead role
  • SME in Visual Inspection of large and small volume parenteral, both Liquid and Lyophilized presentations
  • Experience with inspection and manufacturing equipment/processes that comply with regulatory requirements
  • Experienced with GMPs, SOPs and working within an FDA / EU regulated environment
  • Proficient with MS Office (Word/Excel/Access)
  • Work across multiple departments to achieve goals and objectives
  • Ability to coach, train and mentor employeesPHYSICAL REQUIREMENTS
    • Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English
    • Requires the ability to communicate effectively using speech, vision, hearing and written word
    • Must be able to work while wearing PPE for all GMP areas for an entire shift (Includes non-latex gloves, hairbeard covers and lab coats)
    • The employee is regularly required to sit while performing motions requiring high manual dexterity for up to 8 hours per day
    • Specific vision abilities required include close vision, color vision, distance vision, peripheral vision, depth perception and the ability to adjust focus; need for 20/20 vision corrected or uncorrected
    • Mental Demands: Reading documents and procedures according to GMP standards and regulations. Basic math skills, verbal and written communication skillsCOMMUNICATIONS & CONTACTS
      • Primarily interacts with staff in the following departments at all levels: Operations, Quality, Validations, and Facilities. MANAGERIAL & SUPERVISORY RESPONSIBILITIES
        • Manage approximately 10 Direct / Indirect Reports
        • Screens and recommends applicants for open positions.
        • Makes recommendations for promotions.
        • Recommends and or executes appropriate disciplinary action when requiredThe above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
          
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Keywords: LSNE Contract Manufacturing, Madison , Visual Inspection Supervisor, Other , Madison, Wisconsin