What are the responsibilities and job description for the Quality Assurance Documentation Manager position at American Regent, Inc.?
Internship Overview
">The Manufacturing Change Specialist Intern provides support to Manufacturing Supervision/Management as needed and plays a critical role in maintaining compliance expectations for Corrective and Preventative Actions (CAPAs), Protocols, Change Controls, Annual Product Reviews (APRs), SOPs, and Media Fills. The intern works under the direct supervision of Manufacturing Quality Engineering and collaborates with various Manufacturing and Quality Assurance departments.
Key Responsibilities
- Support the creation or revision of controlled documents, including Standard Operating Procedures, specifications, protocols, product masters/modules, and other miscellaneous documents.
- Prepare controlled documents through the document and change control process, including editing, proofreading, tracking, copying, distributing, scanning, and filing.
- Perform training impact assessments for document change controls by reviewing module assignments and revising applicable document assessments.
- Ensure Change Controls for process and document-related changes are completed or extended before the due date while working with the QA Change Control team.
- Maintain regular communication with impacted departments for scheduled document effectiveness and associated required training.
- Assist in Media Fill execution by reviewing and compiling batch record data.
- Provide support for manufacturing projects, such as capital expansion projects.
- Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures.
