Quality Systems Specialist II

EliteProTek • Carlsbad, CA

3d

About The Position

This role is responsible for the development, implementation, management, and integration of a Quality Management System (QMS). The specialist will execute routine Document Control activities, write and revise Quality SOPs, maintain the Training Program, conduct employee training, perform supplier assessments and audits, and participate in quality events and EQMS system implementation.

Requirements

• 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
• Managing, coordinating, facilitating, and implementing quality assurance standards based on applicable FDA, ICH and ISO requirements experience

Nice To Haves

• Experience with EQMS or EDMS (MasterControl) preferred
• ASQ certification such as CQA or CQE is a plus.

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level