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