The Quality System Specialist participates in maintaining site compliance of operations in accordance with mandated regulatory requirements and site expectations. The Quality Systems Specialist provides oversight of the Quality Management System (QMS) implementation and use. This position may also support global elements of the QMS and lead or participate in continual improvement initiatives.
A typical day might include, but is not limited to, the following:
1. Being responsible for ensuring compliance with all aspects of quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
2. Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
3. Collaborating with cross functional teams in resolving issues, completing investigations and maintaining compliance.
4. Being responsible for QA reviewing and approving of the following types of documents: Failure Investigations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOP’s), GxP documents, Change Control documents.
5. Reviewing various system records for assignment, compliance, and closure.
6. Providing administrative support of electronic systems.
7. Reviewing procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy with local and international regulatory requirements.
8. Monitoring and reporting on trending metrics associated with site quality systems.
9. Actively participating in continuous improvement ideas, initiating, and implementing.
10. Participating in internal, regulatory and customer audits.
11. Training personnel on quality system processes.
12. May be supervising team members.
This role might be for you if:
1. You demonstrate the ability to develop relationships and mentor business users on QMS system requirements.
2. You have excellent written, oral and interpersonal communication skills with ability to optimally interact with a broad spectrum of audiences.
3. You possess excellent time management, communication, and organizational skills along with a proven track record to multi-task required.
4. You have knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.
5. You exhibit a drive for results, dealing with ambiguity, learning on the job and individual courage with a strong attention to detail.
6. You demonstrate project management skills with the ability to manage many diverse tasks simultaneously.
7. You effectively coordinate and manage work responsibilities under general guidance.
8. You are proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
To be considered for this opportunity you must have a 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.
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