Quality - Document Coordinator - TechDigital Corporation
Ayer, MA 01434
About the Job
Job Description:
Must has:
• Experience in MS Office (Word, Excel, PowerPoint, etc.)
• Experience with Document Management systems, either manual or electronic. Electronic preferred.
• Experience archiving controlled / critical records.
• Experience in a regulated environment (Manufacturing, Food Industry, Medical Device, etc.)
Responsibilities:
1. Manages and executes the initiation, processing, routing, distribution and archiving of cGMP documentation.
2. Manages the document change control process, coordinating cross-functional reviews, approvals and effective dates in alignment with requirements (cGMP and Client) and customer needs
3. Serves as a subject matter expert for the electronic document management system.
4. May assist in user training on the electronic document management system.
5. Provides Records Management support during regulatory agency inspections and corporate audits.
Education and skills
• Minimum HS diploma with related experience required. A B.S. degree (in Science, Engineering, or Biochemistry) is preferred.
• A minimum of 2 years of relevant experience including a minimum of 1 year of direct document management experience in a regulated environment focused on product quality.
• Strong teamwork and communication skills and the ability to follow written and verbal instructions.
• Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
• Familiarity with US and EU cGMP regulations and guidance is required.
• Working knowledge of common computer systems such as MS Word and Excel is required.
• Experience with electronic document management systems, is preferred.
Must has:
• Experience in MS Office (Word, Excel, PowerPoint, etc.)
• Experience with Document Management systems, either manual or electronic. Electronic preferred.
• Experience archiving controlled / critical records.
• Experience in a regulated environment (Manufacturing, Food Industry, Medical Device, etc.)
Responsibilities:
1. Manages and executes the initiation, processing, routing, distribution and archiving of cGMP documentation.
2. Manages the document change control process, coordinating cross-functional reviews, approvals and effective dates in alignment with requirements (cGMP and Client) and customer needs
3. Serves as a subject matter expert for the electronic document management system.
4. May assist in user training on the electronic document management system.
5. Provides Records Management support during regulatory agency inspections and corporate audits.
Education and skills
• Minimum HS diploma with related experience required. A B.S. degree (in Science, Engineering, or Biochemistry) is preferred.
• A minimum of 2 years of relevant experience including a minimum of 1 year of direct document management experience in a regulated environment focused on product quality.
• Strong teamwork and communication skills and the ability to follow written and verbal instructions.
• Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
• Familiarity with US and EU cGMP regulations and guidance is required.
• Working knowledge of common computer systems such as MS Word and Excel is required.
• Experience with electronic document management systems, is preferred.
Source : TechDigital Corporation