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Scientific. Clinical. Software Engineering

Snr QA Documentation Specialist

Wayne Metro Area, NJ

Job Type: Scientific Job Number: JN -052020-26798 Region: Wayne Metro Area

Job Description

Snr QA Documentation Specialist - GMP Pharmaceuticals

Responsibilities will include, but are not limited to the following:

Document control & review process of all documents in both the Veeva system platform as well as paper documents.

Will work directly with various departments to ensure documents are accurate

Organize and write supporting documents as needed

Support Periodic Review of Controlled Documents process as well as provide reports and metrics

Creation, modification, issuance, reconciliation of logbooks as well as and updates to templates

Issuance and reconciliation of Laboratory Forms

Revise documents as new issues arise and maintain revision control

80% desk review/computer work

Document Center management, reconciliation and cataloging of physical records

Document Center escort for requestors without card key access in order to review physical records


Additional responsibilities:

Participate in project team meetings and assist the teams in resolving issues related to document preparation and management.

Work with Document Specialist and local functional areas to initiate and maintain electronic repository, and contribute to the authoring, review, and approval process for electronic documents.

Attend QA Department Group Meetings to become informed in upcoming needs.

Implement the strategy for document preparation and review that meet or exceed company standards and the document review processes.

Provide customer support and training for users in the electronic document system.

Provide additional support in processing system requests.

Other duties/responsibilities as assigned.


Skills/Knowledge Required:

Excellent written and communication skills

QA background and familiar with basic GMPs and Good Documentation Practices

Applicant would spend most of their time in the computer based systems related to Document Control

Develop and provide system reports and metrics on a weekly basis.

Management of physical GMP documents

Knowledge of Veeva, ComplianceWire and Deviation/CAPA systems would be a plus.

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