QA Supplier Quality Specialist in West Caldwell, NJ at Volt

Date Posted: 12/16/2020

Job Snapshot

Job Description

Position: QA Supplier Quality Specialist

Location: West Caldwell, NJ

Direct Hire, Salaried up to $95K

VOLT is seeking an experienced Pharmaceutical Manufacturing Quality Specialist.  This position is with a growing pharmaceutical company, manufacturer of pain relief patches and oral thin films.

In this role you will oversee:

  • Supplier Quality Management Program: Verify contracts and purchases, Establish and enforce the program tools to ensure the use of qualified suppliers, and Drive harmonization with global company practices.
  • Qualify suppliers; schedule and perform the supplier audits, and report findings
  • Develop and monitor SCAR metrics to demonstrate the effectiveness of the supplier quality processes.  Maintain a Supplier Corrective Action Report (SCAR) program
  • Act as Lead Auditor during CMO’s supplier audits. Ensure management of supplier audits from planning to completion. Approve and monitor supplier CAPA/SCAR plans and activities to closure including objective evidence of effectiveness.
  • Responsible for the oversight of the Quality Assurance Agreements with contract givers and contract acceptors.
  • Issue Internal Audits Plan on yearly basis
  • Perform SAP Quality functions

Requirements

  • Bachelor’s with a Scientific degree required
  • 10 years of experience in FDA regulated Pharmaceutical Industry in a QA function, with a Minimum of 2 years responsibility for supplier quality oversight and qualification
  • Knowledge of pharmaceutical industry standards: cGMP (21 CFR Parts 210 & 211 & Part 11) Part 4 / 820, etc.
  • Experience Conducting and hosting GMP Audits
  • Excellent documentation skills (SAP, Word, Excel, PowerPoint and Lotus Notes)
  • Excellent team skills and providing feedback

APPLY NOW for consideration.

VOLT is an equal opportunity employer.