What are the responsibilities and job description for the Sr. Quality Compliance Auditor position at United BioSource?
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Sr. Quality Compliance Auditor
Brief Description : Acts in a Lead role within the Company Quality Compliance department to ensure Quality Management System and requirements goals are met. Responsible for ensuring the Company’s quality systems and procedures meet US and international regulatory requirements (e.g., FDA / CRF, GxP, EMA, HRA, EU GVP, GCP) as applicable for business. Performs all appropriate Quality Compliance tasks including hosting / supporting regulatory / client audits and performing internal, REMS, third-party supplier, and investigator site audits. Responsible for writing audit reports, audit responses, and performing appropriate follow-up to completion. Provides assistance and mentorship to other department members as needed. Leads department initiatives, monitors quality metrics, and participates in the Quality Management Council. Facilitates CAPA program, ensures CAPA effectiveness evaluations are performed within a timely manner, performs document review, and ensures Company policies and Standard Operating Procedures (SOPs) are updated within required timelines. Performs other work, as appropriate. Travel as needed, expected 15-20%.
Specific job duties :
- Leads development of annual audit plan(s) for Company and clients, where appropriate.
- Hosts and supports client and regulatory audits. Facilitates development and / or writes audit responses and associated CAPA plans. Ensures CAPA plans are completed as required.
- Conducts internal, third-party supplier, REMS, and investigator site audits. Prepares audit report and tracks follow-up actions.
- Conducts quality compliance document review for the Company and its programs.
- Acts as Lead with department process improvement initiatives and training.
- Participates in and supports Quality Management Council.
- Facilitates Root Cause Analysis (RCA) and completion of CAPA documentation.
- Performs CAPA effectiveness evaluations within a timely manner.
- Acts as a primary Compliance point of contact to support clients directly or indirectly via individual programs.
- Supports and / or conducts review of project-related and application validation documentation, as appropriate.
- Provides assistance and mentoring to other department members.
- Identifies, evaluates and addresses quality issues.
- Assists with development and maintenance of standard operating procedures.
- Performs quality review of project deliverables.
- Performs other quality-related activities as needed / assigned.
- Some travel required for in person audits
Supervisory Responsibility : N / A
Desired Skills and Qualifications :
Benefits :
At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.
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