Quality System Specialist
Maintains site compliance of operations in accordance with mandated regulatory requirements and site expectations.
Daily Responsibilities:
* E nsures compliance with all aspects of quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
* Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
* Collaborates with cross-functional teams in resolving issues, completing investigations and maintaining compliance.
* Reviews and approves documents such as Failure Investigations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOP's), GxP documents, Change Control documents.
* Reviews system records for assignment, compliance, and closure.
* Provides administrative support of electronic systems.
* Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy with local and international regulatory requirements.
* Monitors and reports on trending metrics associated with site quality systems.
* Participates in continuous improvement ideas, initiates, and implements.
* Participates in internal, regulatory and customer audits.
* Trains personnel on quality system processes.
* Supervises team members.
Requirements:
* Develops relationships and mentors business users on QMS system requirements.
* Excellent written, oral and interpersonal communication skills with ability to optimally interact with a broad spectrum of audiences.
* Excellent time management, communication, and organizational skills along with a proven track record to multi-task required.
* Knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.
* Drive for results, dealing with ambiguity, learning on the job and individual courage with a strong attention to detail.
* Project management skills with the ability to manage many diverse tasks simultaneously.
* Effectively coordinates and manages work responsibilities under general guidance.
* Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Education and Experience:
* BS/BA in scientific discipline.
* For Principal Quality Systems Specialist: Requires a minimum of 8 years experience within Pharma or Biotech. Equivalent combination of education and experience will be considered.
* Senior Quality Systems Specialist: requires a minimum of 5 years experience within Pharma or Biotech. Equivalent combination of education and experience will be considered.