What are the responsibilities and job description for the Quality Audit Specialist position at CCS INC?
Qualifications
- Bachelor’s degree in Science or equivalent work experience.
- 3-4 years working in a GMP 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
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
Health Care Benefits
Retirement Plans
Paid Vacation
Retirement Plans
Paid Vacation
Salary : $32 - $36
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