Quality System Specialist
Maintaining site compliance of operations in accordance with mandated regulatory requirements and site expectations is a key responsibility of the Quality System Specialist.
Daily Responsibilities:
* Ensure compliance with all aspects of quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
* Maintain regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
* Collaborate with cross-functional teams in resolving issues, completing investigations and maintaining compliance.
* Review and approve various types of documents, including Failure Investigations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOP's), GxP documents, Change Control documents.
* Review system records for assignment, compliance, and closure.
* Provide administrative support of electronic systems.
* Review procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
* Monitor and report on trending metrics associated with site quality systems.
* Participate in continuous improvement ideas, initiate, and implement.
* Participate in internal, regulatory, and customer audits.
* Train personnel on quality system processes.
Requirements:
* Bachelor's degree in scientific discipline.
* At least 5 years of experience within Pharma or Biotech for Senior Quality Systems Specialist, or at least 8 years of experience for Principal Quality Systems Specialist.
Key Skills:
* Excellent written, oral, and interpersonal communication skills.
* Time management, communication, and organizational skills.
* Knowledge of quality and cGMP principles and systems.
* Project management skills.
* Proficiency in Microsoft Office Suite.
Estimated Salary:
$60,000 - $100,000 per year.