Job Description
Job Description
Employment Type: Full-time
Location: Lee, MA United States
Requisition ID: 1761
Salary Range: $64,397.00 to $77,920.00 annually
Duties:
* Maintain and enhance the company’s quality culture by supporting compliance initiatives and implementing current Good Manufacturing Practices (cGMP) and regulatory requirements.
* Operate within and support the execution of BSM’s 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 facility’s 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:
* Master’s 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 editing GMP 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 company's Careers website.
For questions or inquiries regarding this position, please contact:
Travis P. Ruscio
Corporate Recruiter
Sharp Sterile Manufacturing