Front Line Quality Assurance (FLQA) Specialist

19 Jul 2024

Vacancy expired!

Job Title: Front-Line Quality Assurance (FLQA) Specialist Location: Holly Springs, NC Duration: 6 Months Job Description:

  • The Front-Line Quality Assurance (FLQA) Specialist will provide on the floor support to bulk and fill finish manufacturing, laboratories, and logistics at the Holly Springs site.
  • Core responsibilities of this role include quality checks on the production floor, GMP record reviews, and real time triage of quality related issues.
Main Accountabilities
  • Perform real time logbook review concurrent with manufacturing, QC, or warehouse operations on the floor
  • Perform line clearance activities and standard line start-up checks on the fill finish production line
  • Conduct rejects cage management activities
  • Perform routine quality walkthroughs of site GMP facilities and operations
  • Act as the quality representative on the floor during troubleshooting routine or common issues. Escalate non-routine issues as needed.
  • Use computer systems to support the quality oversight of site operations such as: SAP, CMMS, TrackWise, GLIMS, Delta V, and BAS.
  • Additional administrative tasks as assigned such as document archival and management and reconciliation of batch records
Additional Accountabilities (as applicable):
  • Perform real time batch record review concurrent with manufacturing, QC, or warehouse operations on the floor
  • Provide quality oversight of site critical alarm reports and corrective maintenance program
  • Conduct QA AQL defect confirmations