Quality Documentation Specialist

Proclinical is currently recruiting for a Quality Documentation Specialist with a global pharmaceutical company located in Lexington, MA. Successful candidate will maintain inspection readiness for documentation, training and archiving activities for Oncology, Biologics Quality and Operations, and Facilities.

Job Responsibilities:

• Coordinate document workflows.
• Training module administration.
• Support Quality File Rooms, archiving and record management.
• Supports Principal Archivist Program, disaster recovery, vital records, and internal audits to ensure compliance.
• Perform all aspects of Documentation: Document submissions, scanning, retrievals and off-site archiving.
• Create and manage training modules in LEADs.
• Act as primary contact/SME for documentation and file room customers.
• Coordinate training assignments for employees.
• Provide reports and support as needed for Quality audit and inspection activities.

Skills and Requirements:

• High School Diploma with 1-3 years' experience in pharma and/or GxP environments.
• Prior documentation/record management/archiving experience is required.
• Strong communication skills.
• Collaborative skills and strong customer service mindset.
• Prior experience using validated documentation and training management systems.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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