QA Specialist

New Brunswick, NJ 08901

Post Date: 03/16/2018 Job ID: 8087 Industry: Pharma Pay Rate: $20.00 - $22.00





RESPONSIBILITIES



    • Support for the Polymer Manufacturing Project including:



    • Issuance and control of all Batch Records, protocols, equipment validation documents, Specs, Methods, Templates



    • Release of Raw Materials



    • Line clearance for Media and Ampligen runs



    • Review of all manufacturing related support documentation and forms after the batch is complete:



        • Clean in place documentation



        • Utilities verification



        • General cleaning for room/line clearance



    • Document Control



      • Maintenance, control, storage, and archival of all GMP documents



      • Issuance and control of Logbooks for Manufacturing and QC Departments



      • Drafting, reviewing and approvals of SOP's; provided consultation in development of new SOP's to ensure product development conforms with GXPs



      • Perform audits for documentation system, consisting of (SOP, Specifications, Methods, etc.) binder updating.



    • Review and approval of QC data



    • Issuance and control of Logbooks for Manufacturing and QC Departments



    • Maintenance, control, storage, and archival of all GMP documents



    • Backup for all other QA functions



QUALIFICATIONS



    • BS in a technical subject with 1 to 3 years of pharmaceutical industry experience.



    • Possesses an in depth expertise in desktop applications and document management and publishing systems.



    • Knowledge of drug development and regulatory process desired.



    • Strong oral and written communication skills, ability to work in teams and multitask needed.



    • Demonstrates attention to detail and accountability.





Not ready to apply?

Send an email reminder to:

Share This Job:

Related Jobs: