Quality Assurance Batch Reviewer

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Wharton, United States the ASSURANCE group Full time

Packaging Manufacturer of Cosmetics is seeking a Quality Assurance Batch Reviewer to join their team. This position is primarily responsible for reviewing and overseeing the validations executions for testing, equipment, batch processes, facility and cleaning of cosmetic & OTC manufacture and production.

The Quality Assurance Batch Reviewer will be responsible for:

  • Reviews and approves validation master plans, validation protocols, validation reports, validation deviations, SOP’S and other validation documentation in support of product release.
  • Reviews and coordinates with Tech Service team the validation plan, schedule and organize new & existing validation projects including laboratory equipment, water systems, manufacturing and filling equipment, manufacturing and filling processes, plant systems, storage facilities and cleansing & sanitization processes.
  • Managing the validations execution with the appropriate departments and personnel and, to provide them with the correct training of the validation protocol requirements.
  • Provides technical input on validation deviations, proposes site-specific validation procedures and shared practices as applicable.
  • Coordinates with Tech Service team the qualification IQ/OQ/PQ activities with manufacture, production, sanitization, quality control and outside testing facilities providing leadership, guidance and training.
  • Reviews and approves protocols for validation/qualification IQ/OQ, PQ of existing processes, methods and equipment according to approved protocols and SOPs.
  • Reviews the validation documents to analyze data, adjust where needed to confirm that a manufacturing or production process has consistent results and meets regulatory standards.
  • Troubleshooting / investigating validation-related deviations.
  • Maintaining organization and archival of completed validation and qualification document packages.
  • Work with Tech Service team, manufacturing and Production to generate Failure Mode & Effects Analysis (FMEA) and risk assessments of new projects.

Job Requirements

  • 3+ years relevant experience in validation / batch processing role (regulated Cosmetic or Pharmaceutical industry)
  • Familiar with validation discipline and processes.
  • Familiar with CAPAs, Change Controls, OTC, FDA audits & investigations.
  • Adept at Microsoft Office suite.
  • Positive attitude, to adapt to fast changes, work under a lot of pressure, teamwork and have initiative. Bilingual is a plus.


For immediate consideration, please send resume outlining your related validation experience.


No relocation offered.

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