Team Leader, Aseptic Filling

Description

Duties & Responsibilities

• Prepare daily/weekly production schedule, batch documentation and allocate the appropriate resources to the production teams
• Ensure production schedule and complete associated documentation in compliance with regulatory requirements
• Ensure raw materials are available and inventory accuracy is maintained
• Oversee training and qualification of team members
• Ensure equipment and facilities are properly maintained
• Review in-process documentation for accuracy and compliance in a timely manner
• Become proficient in departmental process activities
• Conduct annual employee performance reviews and assign individual goals/objectives
• Monitor team performance through Key Process Indicators
• Escalate issues related to personnel, process and products to the appropriate leaders
• Analyze key improvement opportunities and implement selected new ideas
• Initiate/facilitate root cause analysis and implement corrective and preventative actions to address problems
• Perform quarterly reviews and revisions to all process documentation
• Manage departmental expenses to ensure budget adherence
• Demonstrate a visible ' tangible commitment to HSE, Lean Principles, and the Merial Values in all work related activities
• In addition to the above, other assigned duties ' projects deemed appropriate within the position scope

Requirements

• High School Diploma or equivalent, plus minimum eight (8) years relevant experience -OR-
• B.S. degree from an accredited institution, plus four (4) years relevant experience
• Demonstrated leadership skills - Coaching/Training
• Work effectively in a team environment
• Results oriented and ability to meet firm deadlines while working in a complex and variable environment
• Require knowledge of the current GMPs and USDA requirements
• Knowledge of cGMP manufacturing, product lifecycle knowledge and risks
• Basic math skills
• Equipment/Automation trouble shooting skills
• Clean room and aseptic technique knowledge
• Basic understanding of Lean Manufacturing principles
• Proficient with Microsoft Office software and other database software
• Excellent oral and written communication skills

Desired Skills, Experience and Abilities

• B.S. from an accredited institution in Biology or related field, plus five (5) years of experience in related field
• Strong organizational, time management, and project management skills, with exceptional attention to detail

You should be proficient in:

• Leadership / People Management
• Pharmaceuticals