Compliance Specialist

Job Summary:

• Support the Regulatory Compliance group by assisting in audit preparation, audit execution and closure. 

• Responsible for executing weekly and monthly department reports and following up with action owners across the company to insure timely completion of activities. 

• Create weekly/ monthly audit metrics reports and communicate results. 

• Develop and perform audit trending reports. 

• Review audit responses for adequacy of root cause investigation and GDP. 

• Execute change process for Client audit procedures.

• Education (is a degree required or preferred, etc): Degree required

 Technical Experience:

• CQA or ISO 13485 Lead Auditor Certification Required.

• Proficiency in Microsoft Xcel required.

• Knowledge/Experience with Medical Device Regulations (21 CFR 820 or ISO13485) preferred.

• Knowledge of Good Documentation Practices preferred.

Sneha Shrivastava Integrated Resources, Inc IT REHAB CLINICAL NURSING Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 & 2013 (7th Year) Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

Direct: (732) 549 5307