Quality Assurance Archivist - HYBRID

Proclinical is seeking a hybrid Quality Assurance Archivist for a global pharmaceutical company located in Cambridge, MA.

As the Quality Assurance Archivist, you are responsible for maintaining the integrity and traceability of the documentation archived by the R&D organization at this site and managing the long-term retention of electronic and paper documents. You will also oversee the set-up and long-term management of the document destruction process at the site at the end of the document retention period.

Must be eligible to work in the US.

Job Responsibilities:

• Manage the archiving process of the documents of the RD organization in an efficient way, to guarantee traceability in compliance with VQD-SOP-068376
• Preserve the documents generated and archived by Vx RD functions at this site (notebooks, annexes, records), and ensure the management of the document life cycle (e.g., return, consultation, loan, modification, destruction, etc.) while maintaining traceability in the systems
• Manage approved archives (lifecycle, destruction, access, etc.)
• Manage the appropriate access to eArchive
• Organize consultation and borrowing of requested documents in collaboration with internal & external partners and ensure traceability according to the SLA
• Organize and ensure the archive outsourcing process in collaboration with the external partner
• Organize the archive scanning process for legacy records to be borrowed
• Update, adapt and improve the defined performance measures and indicators to ensure monitoring of the archiving processes
• Ensure & maintain the integrity and confidentiality of data
• Implement, organize, and ensure the destruction of the records according to the retention schedule and preservation notices
• Provide support, coaching and training to the user in the archiving of his data, both for paper & electronic records
• Support audits and inspections of interest to the service
• Participate to CAPA and deviations completion
• Actively participate in alignment meetings in the global context of the new Record Management and Archival (RMA) process
• Connect with the Departmental Archiving Lead (DAL) & Vx Execution Team
• Create and manage queries/reports to evaluate and maintain the quality of the process and system
• Collaborate with internal & external partners to comply with applicable procedure and regulations
• Promote good documentation practices in the frame of archiving
• Support function archivists upon needs

Skills and Requirements:

• Bachelors Degree
• At least 1 years of professional experience in specified fields.
• Technical experience in archive, and/or documentation management.
• At least 1 year of proven experience of individual responsibility for supporting R&D Business or projects.
• Experience in quality management, compliance, quality assurance, regulations and monitoring is an asset as well as organizational awareness.
• Archive management knowledge
• Knowledge of international regulatory requirements that apply to vaccines development; in-depth knowledge of GxP
• Ability to understand complex processes and to summarize
• Ability to manage and coordinate multiple inputs simultaneously
• Customer focus, team player, proactive and reliable
• Combines good IT skills with an ability to interact in different scenarios and under pressure
• Result driven, precise and willing to learn

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at +(1) 267-846-2026 or j.cerchio@proclinical.com.

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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