QA Supplier Quality Specialist in West Caldwell, NJ at Volt

Date Posted: 8/30/2018

Job Snapshot

  • Employee Type:
    Direct Hire
  • Duration:
    N/A
  • Date Posted:
    8/30/2018
  • Job ID:
    131615
  • Pay Rate
    $90000.0 - $95000.0/Year
  • Contact Name
    Volt Branch
  • Phone
    317-685-2200

Job Description

Position: QA Supplier Quality Specialist

Location: West Caldwell, NJ

Status: Direct Hire

JOB DESCRIPTION:

This position is the primary point of contact for the oversight of the supplier quality management program that ensures contracts with and purchases from qualified suppliers. 

This role is also the point of contact for customers for GMP audits (scheduling, hosting and follow-up).

Management of the customer audit program including scheduling, hosting, coordination of staff and resources and tracking observations, responses and commitment timelines.

  • Supplier Quality Management Program: establish and enforce the program and tools that ensures the client uses qualified suppliers.  Drive harmonization with global company practices.
  • Qualify suppliers as per procedure; issue an annual schedule of supplier audits; schedule and perform the supplier audits and issue findings within SOP defined timelines and issue qualification documentation.
  • Responsible to perform SAP Quality functions and approvals for the use of suppliers and materials.
  • Responsible to establish and maintain a Supplier Corrective Action Report program.
  • Responsible for the oversight of the Quality Assurance Agreements with contract givers and contract acceptors.
  • Prepare and issue certifications (ex; BSE, Latex free, Non GMO, GMP)
  • Coordinate and manage the results from the monitoring of the site’s Environmental Monitoring and USP Water System.  Review data for trends and act upon appropriate action/alert limits or the observation of an emerging trend.
  • Basic Office Setting – Exposure to Computer Monitor

REQUIREMENTS: 

  • BA or BS degree in a scientific discipline.
  • 10 years of experience in an FDA regulated Pharmaceutical Industry in a QA function. 
  • Minimum of 2 years in a role that was responsible for supplier quality oversight and qualification
  • Knowledge of industry standards, concepts and current cGMP (21 CFR Parts 210 & 211 & Part 11) Part 4 / 820 and other agency standards as they relate to quality systems/quality assurance.
  • Experienced in conducting and hosting GMP Audits
  • Excellent reading, writing and verbal skills.
  • Proficient in word, excel, power point and lotus notes

Please apply to position or contact Matt Haltom at (317) 685-2200 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