QA Compliance Specialist

Employment Type: Full-time

Location: Lee MA United States

Requisition ID: 1761

Salary Range: $64397.00 to $77920.00 annually

Duties:

* Maintain and enhance the companys quality culture by supporting compliance initiatives and implementing current Good Manufacturing Practices (cGMP) and regulatory requirements.

* Operate within and support the execution of BSMs Quality Management System.

* Author review and approve documentation required for compliance with FDA EU and other applicable regulatory agency requirements.

* Serve as the primary owner of quality systems including change controls deviations Corrective and Preventive Actions (CAPAs) work orders and other GMP-related documentation.

* Assist with and conduct internal audits and routine walkthrough inspections of manufacturing areas; author review and approve associated audit reports.

* Collaborate with cross-functional departments to meet project and compliance objectives.

* Support the execution of the facilitys pest control program.

* Demonstrate a strong quality mindset and conduct business in compliance with all relevant state federal and OSHA regulations.

* Maintain a comprehensive understanding of FDA EU and other applicable regulatory requirements.

Requirements:

* Masters degree in Regulatory Affairs or related field (or foreign degree equivalent)

* At least one (1) year of quality assurance experience in a cGMP environment.

* At least (one) 1 year of experience reviewing and editingGMP documentation including change controls deviations CAPAs and SOPs.

* At least (one) 1 year of experience supporting internal audits and preparing documentation for FDA or other regulatory inspections.

* At least (one) 1 year of experience performing root cause analysis and developing corrective and preventive actions (CAPAs).

* At least (one) 1 year of experience using electronic quality management systems (e.g. MasterControl Veeva or similar)

* At least (one) 1 year of experience using Microsoft Office (Word Excel PowerPoint) and Adobe Acrobat.

* At least (one 1 year of experience with compliance and data integrity best practices.

* At least (one) 1 year of experience managing multiple projects and timelines to meet department goals.

Application & Inquiries

Interested individuals may apply through the companys Careers website.

For questions or inquiries regarding this position please contact:

Travis P. Ruscio

Corporate Recruiter

Sharp Sterile Manufacturing