Intertwined

QA On-the-Floor Supervisor (re-lo to Baltimore)

Full Time
Raleigh, NC, USA
Description

The Denzel Group, an award-winning search firm, has been chosen to work with a Pharmaceutical industry leader on their quest for a talented QA On-the-Floor Supervisor. In this role you will provide quality on the floor oversight to support manufacturing operations and compliance.


Responsibilities

  • Management of the QA OTF team and program, leading daily operations, and a program supporting 24/7 manufacturing operations. This including definition of needed roles.

  • Manage QA OTF program compliance.

  • Commercial and Clinical Product Quality oversight

  • Develop, implement, and improve quality processes.

  • Determine real-time deviation impact, and the need for investigations.

  • Manage alignment with client expectations and on-time batch delivery.

  • Participate in FDA inspections regarding Raw Materials.

Requirements
  • Relevant BS Degree, at minimum.

  • 6+ years’ GMP Quality experience in relevant aspects such as QA, QC, Manufacturing, etc.

  • Strong knowledge of GMP compliance regarding Batch Production Records, documentation, materials.

  • Strong experience supporting deviation investigations, as well as CAPA generation/implementation


To apply please email your application to mschroeder@thedenzelgroup.com


QA, OTF, quality on the floor, GMP, QC, quality control, batch record, investigation, deviation, CAPA, supervisor, manager, specialist, analyst.


#IND1

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