Quality Systems Specialist II

• Bachelor’s degree in Science or equivalent work experience.
  
• 3-4 years working in a GXP or ISO regulated environment.
  
• 1-2 years in a Quality Assurance related role.
  
• Working experience in internal or supplier audits and hosting external audits
  
• Experience with EQMS or EDMS (MasterControl) preferred
  
• ASQ certification such as CQA or CQE is a plus.
  
• Managing, coordinating, facilitating, and implementing quality assurance standards based on applicable FDA, ICH and ISO requirements experience
  

• Development, implementation, management and integration of a Quality Management System (QMS)
  
• Execute routine Document Control activities per KLS SOPs, QMS, and applicable regulatory requirements.
  
• Write and revise Quality SOPs, and other related procedures.
  
• Maintain the Training Program and conduct employee training on applicable Quality SOPs, regulatory requirements, and ISO/ICH standards
  
• Conduct supplier assessments and routine/qualification audits
  
• Participate in the initiation, documentation, and management of quality events
  
• Participate in and support the implementation of the EQMS system
  

Benefits

• Medical, Dental & Vision Insurance for employees and dependents
  
• Basic & Supplemental Life and AD&D Insurance
  
• Long Term Disability Insurance
  
• 401(k) Retirement Plan
  
• Employee Assistance Program
  
• Health Care & Dependent Care Reimbursement Account