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PCI
Bedford, NH, USA; USA_NH_Bedford_29Har
Source: PCI careers · View original posting
From PCI's posting. “We” and “our” refer to the employer.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The individual will manage, coordinate, and maintain cGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived. The Document Control QA Specialist II will evaluate document needs and participate in the processing of Documents and Records, maintain databases and Quality Management System tools and supports personnel and functional areas as needed.
The primary objective of the Document Control QA Specialist II will be to contribute to the maintenance and improvement of the Document Control program and its systems. The QA Doc Control group is dedicated to the continuous improvement of the Document Change Control Lifecycle and Quality Systems to meet current compliance standards and ensure proper processing and release of controlled documents.
Maintain Quality System Master Documents and Master Document List
Facilitates workflows in the electronic document management system and legacy paper processes.
Performs the creation, modification, and approval of Client Batch Records independently.
Issues and reconciles batch records, testing data capture sheets, lab books, equipment log books, room log books, and Quality System event documents.
Maintains Document, Material and Batch numbering logs.
Writes and develops QA SOPs with minimal oversight.
Administers the maintenance of the Record/Document filing system at designated sites.
Proofs and edits document changes including minor SOP updates, as directed.
Participate in or lead audit preparation and reconciliation. Support audit requests. Perform internal audit tasks.
Supports metrics / report generation.
Cross-trains and provides support for coverage of multiple production facilities as needed. Covers absences.
Lead continuous improvement efforts and projects across the department, or multiple departments. Provide input, propose resolutions.
Performs obsolete and administrative document workflow within Master Control.
Leads Quality System Investigation and CAPA action items
Train others in doc control processes.
Develops and implements new tools and processes for Document Control with minimal oversight.
Participate in or facilitate functional area programs.
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