Quality Analyst

Remote: 
Hybrid
Contract: 
Work from: 
Gaithersburg (US)

Resource Logistics Inc. logo
Resource Logistics Inc. SME https://www.resource-logistics.com/
201 - 500 Employees
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Job description

Location: 100% onsite
Duration: 2months
Shift: Day Shift
Hours: 8:30am-5pm


Accountabilities:
- Perform scanning, indexing, and electronic filing of executed GMP records in compliance with 21 CFR part 11 and internal SOPs.
- Ensure completeness, accuracy, and legibility of scanned documents prior to Clienthiving.
- Support the retrieval and tracking of GMP records as needed.
- Identify and escalate documentation discrepancies or quality issues to QA Management.
- Collaborate with cross-functional teams including but not limited to QC, Manufacturing, Facilities and Engineering, and Tech Ops, ensure timely processing of records.
- Utilize Veeva Vault or other electronic document management systems (EDMS) for uploading and indexing records, where applicable.
- Assist in the continuous improvement of documentation handling and scanning procedures.
- Maintain record retention logs and ensure adherence to established retention schedules (GRAD).

-Bachelor Degree
-Prior GMP experience
-Experience with 21 CFR part 11
-Experience Indexing, Clienthiving, organizing, filing etc.

Required profile

Experience

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