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Mnfg QA Specialist- On the Floor

Mnfg QA Specialist- On the Floor

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 Quality on the Floor Manufacturing, Specialist. In this role, you will provide QA oversight of manufacturing processes via real-time audits, as well as write and revise documentation.

Responsibilities

  • Real-time batch record review, disposition, and in-process auditing.
  • Walkthroughs of GMP areas to ensure inspection readiness of facility.
  • 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.
  • Write, review and assesses deviations, closure of CAPAs, Gap Analysis and Product Complaints.
  • Implement solutions for manufacturing operations.

Required

  • BS or BA degree in Science or Engineering.
  • 5-10 years’ GMP experience.
  • Strong experience performing on the floor audits, real-time GMP document review, and closure of CAPAs.
  • Experience authoring and revising SOPs, reviews, and deviations.

Specialist, Analyst, QOTF, on the floor, GMP, batch record review, audit, facility, SOP, deviations, CAPA.

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