QA Batch Auditor in West Caldwell, NJ at Volt

Date Posted: 9/3/2020

Job Snapshot

Job Description

QA Batch Auditor – 1st Shift

Location: West Caldwell, NJ   07006

Status: 12+ month contract

Volt is seeking a 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. Grow your career and learn new techniques with this growing pharmaceutical company!

In this position you will:

  • Review batch records and CofAs to ensure that product released is compliant with company standards.
  • Complete reviews in a timely manner and meet SAP confirmed delivery dates for products, update SAP statuses, and update QA Batch Record Log.
  • Identify errors in batch records and CofAs and effectively communicate with teams to resolve issues.
  • Recognize errors that warrant the issuance of an event notification, investigate as needed, and speak with the responsible parties and complete 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.
  • Maintain relationships with QA counterparts, notify them of investigations, complete requests for information, and prepare the required batch disposition documentation.
  • Complete all required SAP transactions needed to release product or to process material rejection requests that are approved by the LTS material review board.
  • Maintain custody of batch records and CofAs, properly file them after product release, and archive them when due for the required record retention period.
  • Review Batch Record Review Data Collection forms to support product complaints.

Requirements

  • Bachelor’s Degree
  • 7-8 years’ in Quality and/or Pharmaceutical field, GMP regulated
  • Knowledge in CFR parts 210, 211 and 820 regulations, ICH Q8/Q9/Q10 guidelines for process development and current regulatory GMP initiatives
  • Great reading, writing and verbal skills, and computer skills

Please contact Matt Haltom at (317) 599-4898 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.

Volt is an Equal Opportunity Employer