QA Batch Auditor in West Caldwell, NJ at Volt

Date Posted: 11/1/2019

Job Snapshot

  • Employee Type:
  • Duration:
    24 weeks
  • Date Posted:
  • Job ID:
  • Pay Rate
  • Contact Name
    Volt Branch
  • Phone

Job Description

QA Batch Auditor

Location: West Caldwell, NJ

6 month contract, up to $35/hr

Volt is seeking QA Batch Auditor for a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as oral thin films and transdermal patches.

Primary Job Functions:

  • Reviews executed batch records and Certification of Analysis (CofAs) to ensure that product released by the company is in adherence with established written procedures, product specifications and approved protocols.
  • Self manages reviews to ensure they are completed in a timely manner to meet SAP confirmed delivery dates for assigned products, and accurately populates the current status of such reviews into SAP and the required metrics thereof into the QA Batch Record Log.
  • Identifies any errors or GDP deficiencies in the batch records and CofAs during reviews and effectively communicate them to the responsible individuals to have them resolved
  • Recognize errors that warrant the issuance of an event notification to have the matter investigated and effectively communicates such to the responsible parties in a timely manner to facilitate the completion of the investigation.  
  • Query Event Notification database and SAP (Inspection Lot Short Text) for Event Notification, Change Controls and Validation Protocols to ensure they are closed out prior to releasing an associated batch.
  • Maintains a good working relationship with the business partner‘s QA counterparts, effectively notifies them of investigations that warrants their attention as per established quality agreements, promptly attends to their questions or requests for information, and prepares and forwards the required batch disposition documentation for their notification or  review and approval.
  • Completes all required SAP transactions needed to release product or to process material rejection requests that are approved by the material review board.
  • Maintain custody of received executed batch records and CofAs, properly files them after product release, and archives them when due for the required record retention period.
  • Reviews Batch Record Review Data Collection forms to support product complaints.

To succeed in this role, you need the following skills:

  • Bachelor’s Degree
  • 7-8 years’ in Quality and/or Pharmaceutical field
  • Knowledge in CFR parts 210, 211 and 820 regulations, ICH Q8/Q9/Q10 guidelines for process development and current regulatory GMP initiatives
  • Basic reading, writing and verbal skills
  • Proficient in word, excel and power point
  • Basic average mathematic skills
  • Excellent team player

Please APPLY NOW and contact Matt Haltom at (317) 599-4898 for any questions and more details regarding this position.  Volt is an Equal Opportunity Employer