QA Documentation Associate

Dayton, New Jersey
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 153327

Date Posted: 06/29/2020


Title:  QA Documentation Associate

Location: Dayton, NJ

Schedule: Monday-Friday 8a-5p

Type: Direct Hire

Start date: ASAP

Established Pharmaceutical company looking to hire immediately!  Looking for QA Documentation Associate.

Responsibilities:

Batch Record Issuance/Change Control Document issuance
Work with training records/SOPs/STP/GP
QA Activies- Extra Page/Notebook/Logbooks/Archivals/ERP, etc.

  • Maintain the Manufacturing and Packaging Batch Record Master Hard copy and Pdf soft copy.
  • Help in the GMP Training of New Hire Employees and create and maintain the New Hire Employee Training Folders.
  • Maintain the Change Control Spreadsheet and documentation related to Change Control.
  • Issue Batch Record for production and maintaining the Master Batch Record Documentation
  • Change Control AI closing update and archival digitally and physically of closed CC
  • Issue of Notebook/Logbook, Extra Page of Batch Records
  • Archiving of the Stability/RA/RI/PM LIMS Data Pkt.
  • Making the STP/SPC/GP and Manual COA effective, issue Control Copy, Scan to S drive and archiving
  • Preparing Draft and making Final Print for SOP revision
  • Stability Protocol Approval LIMS/Manual
  • APR Specifications and collecting data for trending and data submission to regulatory for Annual Reports.
  • Document Archival – using the Kardex Storage units.

Requirements:

  • Bachelor’s Degree
  • 2+ years of GMP related industry experience in QA
  • Batch Record Issuance experience
  • Experience maintaining Change Control and Change Control Issuance

 

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.  For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.


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