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Company

Source One Technical Solutions

Address Malvern, PA, United States
Employment type CONTRACTOR
Salary
Category Pharmaceutical Manufacturing
Expires 2023-10-01
Posted at 8 months ago
Job Description

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global pharmaceutical company in Malvern, PA.


Title: QA Systems Document Management Specialist (Contractor)

Pay Rate: $25.55/hr (W-2)

The contract duration is initially 3 months


Summary: Provides QA Document Management services to designated manufacturing and R&D sites. Ensures compliance to the Quality Systems procedures and policies. Maintains GMP archive, coordinates indexing and off-site storage of documentation according to Records Management procedures. Support document processing, setting effective dates in the Veeva Document Management System. Issue and archive logbooks, maintain tracking database.


Responsibilities:

• Partner with internal departments to ensure documentation changes align with internal requirements; coordinates effective dates for procedural documents.

• Maintains the GMP Archive by coordinating requests, off-site storage according to records management procedures, timely filing of documentation.

• Coordinates the issuance and archival of Logbooks, provides timely notification of new, revised, recalled logbooks.


Qualifications:

• Bachelor’s Degree in Engineering, Science, or other subject area

• 1-2 years’ experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industries

• Experience in Document Management preferred

• Strong organizational skills and attention to detail

• Ability to lift boxes up to 20lbs