Title:  Supervisor, Extractables & Leachables

Job Summary

The extractables & leachables supervisor is responsible for managing the day-to-day operations of the Extractables & Leachables analytical testing group.

Essential Duties and Responsibilities

• Supervise the day-to-day activities in the Extractables & Leachables group
• Assure that analysts have been adequately trained for their role.
• Assist the Manager in proper management of resources of the group including analyst work assignments.
• Collect and evaluate metrics pertaining to operations.
• Implement continuous improvement/lean activities and events for the group.
• Assure compliance to West’s Services and Solutions quality systems.
• Follow required cGMP regulations and internal QA procedures.
• Supervise and approve laboratory investigations to support internal and external customers.  
• Supervise and implement the development and validation of numerous analytical techniques.
• Write, review, and approve documents such as laboratory investigations, work instructions, SOP’s, etc.
• Support internal and external audits.
• Participate in cross functional teams as laboratory operations leads to provide input and consultation for laboratory testing and projects.  
• Hire new employees ensuring that their qualification and skills fit with the needs of the individual role.
• Develop competency with multiple complicated techniques, equipment, and/or test methods.
• Independently drive projects from initiation through completion.  
• Mentor
• Organize West material or technology focused studies and effectively communicate results.
• Lead communications with internal and external customers.
• Design and implement training strategies.
• Meet individual and departmental goals and metrics.
• Make rational and sound decisions at a program level.
• Adhere to established laboratory safety procedures.
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Other duties as assigned.

Education

• Bachelor's Degree in relevant scientific field

Work Experience

• Minimum 5 years in a directly related field and a cGMP environment
• A subject matter expert in directly relevant field.
• Knowledge and/or hands on experience with a variety of analytical techniques including LCMS, GCMS, and ICP

Preferred Knowledge, Skills and Abilities

• cGMP
• Extractables & Leachables
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target 
• Previous supervisory experience 

Additional Requirements

• Job-related activities that require a physical activity such as standing in laboratory environment
  • Effective dexterity to operate objects, tools, or controls and reach with hands and arms.  
  • Employee may be required to lift heavy objects (up to 25 lbs.) without assistance
  • Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures) #LI-JJ1

Travel Requirements

Physical Requirements