QA Archivist - Level 2 (Pharma)
Alphanumeric is hiring a Archivist - Level 2 to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.
Contact role:
6-months Hourly pay rate:
in the region of $60 per hour - 40 hours per weekThe Archivist is responsible for maintaining the integrity and traceability of the documentation archived by Vaccines R&D and managing the long-term retention of electronic and paper documents.
The Archivist also oversees the set-up and long-term management of the document destruction process at the site at the end of the document retention period.
Key
Responsibilities:
Archivist activitiesoManage the archiving process of the documents of the RD organization in an efficient way, to guarantee traceability in compliance with VQD-SOP-068376oPreserve the documents generated and archived by Vx RD functions at (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 systemsoManage approved archives (lifecycle, destruction, access, etc.
)oManage the appropriate access to eArchiveoOrganize consultation and borrowing of requested documents in collaboration with internal & external partners and ensure traceability according to the SLAoOrganize and ensure the archive outsourcing process in collaboration with the external partneroOrganize the archive scanning process for legacy records to be borrowedoUpdate, adapt and improve the defined performance measures and indicators to ensure monitoring of the archiving processesoEnsure & maintain the integrity and confidentiality of dataoImplement, organize, and ensure the destruction of the records according to the retention schedule and preservation noticesoProvide support, coaching and training to the user in the archiving of his data, both for paper & electronic recordsoSupport audits and inspections of interest to the serviceoParticipate to CAPA and deviations completionoActively participate in alignment meetings in the global context of the new Record Management and Archival (RMA) processoConnect with the Departmental Archiving Lead (DAL) & Vx Execution TeamoCreate and manage queries/reports to evaluate and maintain the quality of the process and systemoCollaborate with internal & external partners to comply with applicable procedure and regulationsoPromote good documentation practices in the frame of archivingoSupport function archivists upon needs.
Education:
Relevant Bachelor from recognized University / High School This individual will be required to partner with a wide variety of individuals in the organization and be able to communicate effectively about technical procedures relating to archiving, training and education ensuring that people from different backgrounds can appropriately follow.
Moreover, the role will be key to constantly enhance innovation and continuous improvement therefore a high preparation to different scenarios and approaches is recommendable.
Experience:
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.
Job Related Skills:
oArchive management knowledgeoKnowledge of international regulatory requirements that apply to vaccines development; in-depth knowledge of GxPoAbility to understand complex processes and to summarizeoAbility to manage and coordinate multiple inputs simultaneouslyoCustomer focus, team player, proactive and reliableoCombines good IT skills with an ability to interact in different scenarios and under pressureoResult driven, precise and willing to learn Recommended Skills Auditing Business Process Improvement Communication Confidentiality Consulting Curiosity Estimated Salary: $20 to $28 per hour based on qualifications.
Contact role:
6-months Hourly pay rate:
in the region of $60 per hour - 40 hours per weekThe Archivist is responsible for maintaining the integrity and traceability of the documentation archived by Vaccines R&D and managing the long-term retention of electronic and paper documents.
The Archivist also oversees the set-up and long-term management of the document destruction process at the site at the end of the document retention period.
Key
Responsibilities:
Archivist activitiesoManage the archiving process of the documents of the RD organization in an efficient way, to guarantee traceability in compliance with VQD-SOP-068376oPreserve the documents generated and archived by Vx RD functions at (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 systemsoManage approved archives (lifecycle, destruction, access, etc.
)oManage the appropriate access to eArchiveoOrganize consultation and borrowing of requested documents in collaboration with internal & external partners and ensure traceability according to the SLAoOrganize and ensure the archive outsourcing process in collaboration with the external partneroOrganize the archive scanning process for legacy records to be borrowedoUpdate, adapt and improve the defined performance measures and indicators to ensure monitoring of the archiving processesoEnsure & maintain the integrity and confidentiality of dataoImplement, organize, and ensure the destruction of the records according to the retention schedule and preservation noticesoProvide support, coaching and training to the user in the archiving of his data, both for paper & electronic recordsoSupport audits and inspections of interest to the serviceoParticipate to CAPA and deviations completionoActively participate in alignment meetings in the global context of the new Record Management and Archival (RMA) processoConnect with the Departmental Archiving Lead (DAL) & Vx Execution TeamoCreate and manage queries/reports to evaluate and maintain the quality of the process and systemoCollaborate with internal & external partners to comply with applicable procedure and regulationsoPromote good documentation practices in the frame of archivingoSupport function archivists upon needs.
Education:
Relevant Bachelor from recognized University / High School This individual will be required to partner with a wide variety of individuals in the organization and be able to communicate effectively about technical procedures relating to archiving, training and education ensuring that people from different backgrounds can appropriately follow.
Moreover, the role will be key to constantly enhance innovation and continuous improvement therefore a high preparation to different scenarios and approaches is recommendable.
Experience:
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.
Job Related Skills:
oArchive management knowledgeoKnowledge of international regulatory requirements that apply to vaccines development; in-depth knowledge of GxPoAbility to understand complex processes and to summarizeoAbility to manage and coordinate multiple inputs simultaneouslyoCustomer focus, team player, proactive and reliableoCombines good IT skills with an ability to interact in different scenarios and under pressureoResult driven, precise and willing to learn Recommended Skills Auditing Business Process Improvement Communication Confidentiality Consulting Curiosity Estimated Salary: $20 to $28 per hour based on qualifications.
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