Team Leader, QC

Job Description

The Opportunity:

To coordinate and ensure QC Microbiology team goals are achieved, and operational decisions made and accomplished promptly. Provide direction and coordination of all activities to ensure compliance with regulatory requirements and company SOPs. To ensure that all scheduling requirements are met, together with other departments where required.

Mentor and develop staff technically and professionally. Supports efforts across multiple areas to accomplish goals, providing guidance and influencing the organization. Provide technical leadership and to co-ordinate the activities of work allocated to the team of analysts; specifically, the collection and testing of samples/raw materials, and support of validation studies. Responsible for supervising daily activities of laboratory group to ensure compliance with quality and reliability standards.

Major Accountabilities:

• Ensure safety is always on the front line.
  
• Schedule the activities of the team observing the Lean Lab solution; monitor and approve time and attendance; ensure training/competence completion; perform 1-1s and development planning; manage performance of all associates. Monitor associated measurements being used to adapt plans accordingly.

• Bachelor's degree in scientific discipline required or equivalent
  
• Advanced ability to communicate technical knowledge
  
• Minimum of 5 years' experience in Quality Control testing techniques and industry practices
  
• Direct experience with regulated environments (cGMP) and experience working in clean room environments
  
• Knowledge of lab safety & data integrity
  
• Experience within matrix / team environment
  
• Experience with laboratory team scheduling
  
• Experience serving as a laboratory SME and leading other team members through delegation and review of tasks
  
• Experience in Track Wise, Veeva, GLIMS, and SAP
  
• Experience with minor or major/complex investigations
  
• Technical competencies: Bioburden testing, endotoxin testing (preferably Kinetic method), sterility testing, growth promotion testing of microbiological media, identification of microbiological isolates, antimicrobial effectiveness testing, water and clean steam collection, gas sampling, environmental monitoring (EM) and EM trending.
  
• Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire