DOCUMENT COORDINATOR
DEVENS, MA

Must have's:
• 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.).

Required Skills:

• Minimum HS diploma with related experience required. B.S. degree (in Science, Engineering, 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, 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.

Project Description:

• Manages and executes the initiation, processing, routing, distribution and archiving of cGMP documentation.
• Manages the document change control process, coordinating cross functional reviews, approvals, and effective dates in alignment with requirements (cGMP and Client) and customer needs.
• Serves as a subject matter expert for the electronic document management system.
• May assist in user training on the electronic document management system.
• Provides Records Management support during in regulatory agency inspections and corporate audits.

This 6+ month position starts ASAP.

ALPHA'S REQUIREMENT #23-00240
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Job Types: Full-time, Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Work Location: One location

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