QA Inspector II - Bottled Products & Compliance

Regulatory Jobs

San Diego (CA)

Sur place

USD 29 000 - 47 000

Plein temps

Il y a 11 jours
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Résumé du poste

Waters is seeking a QA Inspector II to support external customers and internal partners in a regulated, high-volume environment. The role emphasizes visual inspection of bottled products, batch records review, and timely release to inventory, with SAP data entry and archival duties.

You will collaborate with Operations, Packaging, Production Planning and QE to ensure products meet specifications and quality standards, while maintaining strict documentation and traceability in a GMP setting.

Qualifications

  • QA Inspector II supports external and internal customers (Operations, Packaging, Production Planning, QE, Inventory Control).
  • Visual inspection of bottled products, components and kits to verify volume, labels, batch numbers and storage temperature.
  • Review packaging batch records and Technical Data Sheets to ensure inserts are attached.
  • Review dilution, bottling and packaging processes to ensure finished products meet specifications prior to release.
  • Manage QA retention samples and archival systems.
  • Perform SAP data entry and verify batch records accuracy.

Responsabilités

  • Perform visual inspection of bottled products, components & kits, ensuring correct volume, labels, material number and batch number and storage temperature.
  • Review packaging batch records to ensure the correct Technical Data Sheet and inserts are attached.
  • Review dilution, bottling & packaging processes to ensure finished products meet specifications prior to release.
  • File QA retention samples in QA Retention Sample inventory.
  • QA inspection of bottled products and kits/sets.
  • SAP Data Entry.
  • Review and verify the completion of batch records and release products to Finished Goods Inventory.
  • Review and verify raw material supplier documentation and release to inventory
  • Assist in pulling and maintaining QA retains.
  • Oversee company record archival system.
  • Manage temperature monitoring for all QA freezers.
  • Create and update Quality Notifications for process and product deviations or variance.
  • Work with QEs and/or R&D Program Managers to ensure timely release of FGIs or timely new product launch.

Connaissances

Visual inspection
Documentation review
Attention to detail
Team collaboration

Formation

High School Diploma or GED

Outils

SAP
Archival system

Description du poste

Waters is seeking a QA Inspector II to support external customers and internal partners in a regulated, high-volume environment. The role emphasizes visual inspection of bottled products, batch records review, and timely release to inventory, with SAP data entry and archival duties.

You will collaborate with Operations, Packaging, Production Planning and QE to ensure products meet specifications and quality standards, while maintaining strict documentation and traceability in a GMP setting.

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