This role ensures and promotes compliance through external auditing of HCATS’ suppliers, vendors, laboratory services providers, manufacturers for the Allendale, NJ and Mountain View, CA sites based on HCATS’ procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.
The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for HCATS and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites.
Essential Functions and Responsibilities
The Quality Control Microbiology Associate serves as a support role to clinical and commercial production at the Allendale, NJ facility....Apply For This Job
Responsible to perform Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures...Apply For This Job
This position reports to the Quality Assurance Manager. Responsible to perform Quality Assurance activities in support of Quality Systems and/or...Apply For This Job
The QC Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, while adhering to quality...Apply For This Job
MAJOR RESPONSIBILITIES: Act as primary partner on client engagements. Manage engagements in a consistently profitable manner. Review client engagement documentation...Apply For This Job