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Jobs
Documentation Specialist
| Posted On: Aug 23, 2017
Allston, MA 02134
6 Months, Contract
Job Summary
- Job Title:
- Documentation Specialist
- Posted Date:
- Aug 23, 2017
- Duration:
- 6 Months, Contract
- Shift(s):
-
08:30 am - 05:00 pm
- Pay Rate:
- 23.10 /Hourly (compensation based on experience and qualifications)
Description
This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's.
- Responsibilities include:
- Routine review of in process SOPs ensuring cGMP guidelines are followed at all times.
- Management of QA and Quantic Batch Record Responses for all MFG operations teams. Includes investigating and providing appropriate responses.
- Manage timely review and completion of batch record documentation by manufacturing personnel.
- Track hand off of documentation to Quality organization.
- Support the initiation of eWorkflows for Operations document changes.
- Effectively demonstrates an understanding of GMPs & how it applies to documentation review.
- Interacts with other support functions such as QA, QC, and MCT, etc.
Required;
- Good interpersonal and communication skills.