Sr. Quality Compliance Specialist

Irvine, California
Industry: Database Administrator / Engineers
Job Number: JN -062021-65080

Job Description:


Need experienced regulatory compliance specialist with working knowledge to lead and manage Supplier Quality program including Vendor Qualification/Certification as well as execute as lead auditor for the facilitys internal audit program at a sterile manufacturing facility adhering to 21 CFR Part 820, 21 CFR Part 4, and 21 Part 210/211 regulations.

Change control review and approval experience is required and project management is essential.

TrackWise, electronic document management system, and the SAP ERP system knowledge is highly preferred.

Role is a hands on, collaborative, decision making role that will interact routinely with Site leadership and global executive management.


Ref: #JN -062021-65080

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