Intertwined

QA On the Floor Specialist

Full Time
Baltimore, MD, USA
Description

The Denzel Group, an award-winning search firm, has been chosen to work with an industry leader in Baltimore on their quest for a talented QA On-the-Floor Specialist. In the role you will perform quality on the floor activities, interacting with manufacturing personnel and Quality Engineers to provide guidance necessary to maintain and improve CGMP compliance. This involves problem-solving and process improvements.


Responsibilities

  • On the floor real-time batch record review, disposition, and in-process auditing.
    Walkthroughs of GMP areas to ensure inspection readiness of facility.
    Manage resolution of in-process deviations.

  • Write, review and assess deviations, and participate investigations and follow-up plans.
    Support CAPAs, Gap Analysis and Product Complaints.
    Write and revise SOPs

  • Review and approve CGMP documents such as batch records, engineering runs, work orders, logbooks, and reports to ensure compliance with specifications, regulations, and procedures.

  • Support and manage existing and/or develop and implement new programs, processes.

Requirements
  • Relevant BS or BA degree.

  • 5-10 years’ GMP experience, ,mainly in QA on-the-floor activities.

  • Strong experience supporting deviations, investigations, CAPAs.

  • Experience writing SOPs and deviations.

  • Strong experience performing Batch Record review and disposition.


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


QA, quality assurance, specialist, analyst, lead, on the floor, audit, batch record review, SOP, CAPA, deviations, investigations,


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