QA Supplier Quality Specialist in West Caldwell, NJ at Volt

Date Posted: 9/3/2020

Job Snapshot

Job Description

Position: QA Supplier Quality Specialist

Location: West Caldwell, NJ

JOB DESCRIPTION:

Volt is seeking a QA Supplier Quality Specialist 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 with this growing pharmaceutical company!

This position is the primary point of contact for the oversight of the supplier quality management program.

In this position you will:

  • GMP Audit program: scheduling, hosting, coordination of staff and resources and tracking observations, responses and commitment timelines.
  • Qualify suppliers & issue an annual schedule of supplier audits; perform the supplier audits and issue findings within SOP defined timelines and issue qualification documentation.
  • Perform SAP Quality functions, maintain a Supplier Corrective Action Report program.
  • Oversee the Quality Assurance Agreements with contract givers and contract acceptors.
  • Maintain a Supplier Corrective Action Report (SCAR) program.
  • 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. 
  • Develop, implement, and monitor meaningful metrics to demonstrate the effectiveness of the supplier quality processes.
  • Review data for trends and act upon appropriate action/alert limits or the observation of an emerging trend.
  • Perform seated work in office setting, but will require the ability to gown in an appropriate fashion needed to enter the manufacturing and analytical testing areas and host GMP audit tours.
  • Responsible for the oversight of the Quality Assurance Agreements with contract givers and contract acceptors.

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) 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