What are the responsibilities and job description for the Document Control Associate position at American Regent, Inc.?
About the Role
">This internship opportunity 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 Manufacturing Change Specialist Intern works under the direct supervision of Manufacturing Quality Engineering and collaborates with various Manufacturing and Quality Assurance departments.
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.
Requirements
- Pursuing a degree in Science, Technology, Engineering, or Math, with 1 year of college-level courses.
- Experience in editing controlled documents or relevant technical writing experience is preferred.
- Experience in a manufacturing environment or pharmaceutical manufacturing is a plus.
- Work experience in an FDA-regulated environment is a plus.
- Intermediate skills in Microsoft Word and Excel are required.
- Excellent organizational, interpersonal, and communication skills are required.
- Able to read documents in Standard English, such as Standard Operating Procedures, maintenance schedules, and operating manuals.
- Able to self-motivate, manage, organize, and prioritize multiple tasks to meet deadlines.
- Able to take feedback constructively and function in a team-oriented work environment.
- Able to work overtime as needed.
