Monster
 

Confidential Posting

 
 
 

Job Summary

Location
Branchburg, NJ 08876
Industries
Biotechnology/Pharmaceuticals
Job Type
Full Time
Employee
Years of Experience
5+ to 7 Years
Education Level
Bachelor's Degree
Career Level
Experienced (Non-Manager)
Salary
85,000.00 - 95,000.00 USD /year
13% target bonus
Job Reference Code
CAPA

QA Compliance Specialist

About the Job

1.Provide QA presence in Facilities and Metrology areas through periodic walk through, participation in meetings and through systems review.
2.Identify opportunities for continuous improvement.
3.Evaluate Facility and Metrology non-conformances and assess quality impact. Recommend corrective actions as required.
4.Actively participate in cross-functional team discussions of non-conforming events.
5.Review and approve Facility and Metrology SOP’s, trending reports, validation qualification reports, Work Orders and Job Plans.
6.Serve as the technical expert for Facilities, Utility Room and Metrology Labs compliance.
7.Participate in Compliance/Change Management Team Meetings.
8
.Review Facility and Metrology change controls linked to non-conformance events.
9.Provide technical support to Manufacturing Compliance in areas relating to manufacturing/facilities investigations.

10.Participate in the harmonization of Facilities and Metrology document/systems.
11.Participate in Regulatory Inspections as scribe/runner.
12.Provide necessary backup to Facilities Compliance Associate Director.

 
 

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