Job Overview:
Job Purpose:
The QA Specialist plays a critical role in ensuring product quality and regulatory compliance. This individual will be responsible for delivering quality assurance activities, reviewing and approving validation documentation, and qualifying facilities, equipment, and utilities.
Key Responsibilities:
1. Site QA point of contact providing technical expertise, feedback, and guidance for QA and compliance topics/issues.
2. Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
3. QMS areas of responsibility include Deviation, Change Control, and CAPA management systems; Internal/External audits; Customer Complaints; Vendor Management; review/approval Manufacturing Batch Records and assessment/approval of production materials.
Technical, Functional, and Professional Competencies:
* Strong understanding of GMP compliance and quality standards
* Excellent attention to detail and significant document review experience essential
* Excellent technical writing skills including deviation reports and SOPs
* Effective time management and multi-tasking skills
Essential Education and Experience:
* Third-level qualification in a relevant science and/or engineering discipline
* 5 years minimum experience working in a GMP Quality environment
* Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations
Phibro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status, or any other characteristics protected by law.