Job Description
Job Title: Sr. Auditor, Quality Systems
Department: Quality Management Systems
Reports to: Director, Quality Management & Compliance
Location: Boston
The Sr. Auditor primarily serves as a lead auditor under the procedures outlined in PHT’s Quality Management System. Additional responsibilities would include, but not be limited to:
- Developing, maintaining, and reporting performance measures and metrics
- Review of internal documentation for compliance to SOP’s and applicable regulations
- Participating in process improvement projects
- Review and resolution of QMS defects and CAPA Plans
- Assisting Quality Management with response to audits by customers and other external auditors
Specific responsibilities:
Internal Auditing
Under the direction of Quality Management, conduct audits of internal systems, tools, and functions as well as external suppliers for compliance with PHT’s Standard Operating Procedures and external Regulations. Such audits include but not limited to:
– Clinical Trial development, implementation, and archive
– Core software products
– Internal systems
– Internal software tools
– External providers
Following the execution of the audit, the Quality Systems Specialist will
– Track and report quality concerns and problems to Quality Management
– Participate in audit follow up, and Corrective Action procedures
– Act as a resource to staff and management
Client Auditing
Function as the primary contact point for client auditing of our quality systems.
– Planning and preparation of audits
– Developing actions plans and follow-up
– Hosting of client auditors
– Support Sales and Marketing in developing RFI and RFP
Supplier Management
- Maintaining overall supplier management program
- Auditing of supplier operations
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Education: BA, BS or equivalent
Skills & Experience:
· 2-5 years experience in quality systems management, including training and experience with Clinical Trials and auditing
· Knowledge of GCP and international Quality/Regulatory Rules, Standards, Guidelines
· Computer literacy and familiarity with most common software applications such as Microsoft Office applications
· Able to follow written procedures accurately
· Possess strong communication skills
· Work well both independently and as a team player
Employer Contact:
Human Resources
PHT Corporation
500 Rutherford Avenue
Charlestown, MA 02129
Or email your resume and cover letter to hr@phtcorp.com.
