QA Compliance Specialist
About The Position
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 the review and approval of 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 in all aspects of work. 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) and at least 1 year of quality assurance experience in a cGMP environment.
- At least 1 year of experience reviewing and editing GMP documentation, including change controls, deviations, CAPAs, and SOPs
- At least 1 year of experience supporting internal audits and preparing documentation for FDA or other regulatory inspections
- At least 1 year of experience performing root cause analysis and developing corrective and preventive actions (CAPAs)
- At least 1 year of experience using electronic quality management systems (MasterControl, Veeva, or similar)
- At least 1 year of experience using Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat
- At least 1 year of experience with compliance and data integrity best practices
- At least 1 year of experience managing various projects and timelines to meet department goals.
Responsibilities
- 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 the review and approval of 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 in all aspects of work.
- Conduct business in compliance with all relevant state, federal, and OSHA regulations.
- Maintain a comprehensive understanding of FDA, EU, and other applicable regulatory requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
1,001-5,000 employees
