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Quality Assurance Validation Specialist
3 months ago
Packaging Manufacturer of Cosmetics is seeking a **Quality Assurance Validation Specialist **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 Validation Specialist 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.
- About the Assurance group _
IND2
Pay: $65,000.00 - $70,000.00 per year
**Benefits**:
- 401(k)
- Health insurance
- Paid time off
Experience level:
- 3 years
Schedule:
- Monday to Friday
Work setting:
- In-person
- Manufacturing facility
Work Location: In person
