Quality Specialist will:
- Ensure product compliance with L’Oreal’s Standard Procedures and current Good Manufacturing Practices (cGMPs).
- Ensures the implementation of the L’Oreal’s quality requirements including leading root cause analysis after incidents (or near misses)
- Ensure that business stakeholders understand L’Oreal’s quality requirements and how they impact product quality and regulatory compliance
- Provide guidance & input to project teams to ensure compliance to quality requirements during product development. Perform risk assessment on new product quality and compliance related issues.
- Issue Nonconformance notices and follow Root Cause Analysis/Corrective Actions and Preventive Actions (CAPA).
- Work with subcontractors (CM) on status of Quality nonconformities, support investigations and problem solving. Assess risk which may impact product safety or compliance.
- Ensure that CAPAs are initiated, assigned, thoroughly investigated, documented and effectively resolved when deficiencies are found during development, testing, manufacturing. Request waivers when necessary
- Provide support in the management of the quality release process - block the Finished Product (FG) when needed, release FGs in SAP and manage reworks (at the Distribution or 3rd party facility) - rework instructions traceability list, re-control, release
- Provide support in the documentation review process to ensure compliance to established quality requirements
- Assist Quality Manager on new subcontractors Quality Onboarding process
- Train/coach/assist current & new vendors regarding testing methods and procedures
- Create quality documentation to support L’Oreal’s Quality Systems
- Assist quality audits at subcontractors
- Experience and Education Requirements
- A minimum of a Bachelor s degree (or equivalent degree) required. A focused degree in the life sciences or engineering is preferred.
- A minimum of 5 years experience in an FDA (or Health Canada)-regulated industry is required
Experience and understanding of the following regulations is required: Cosmetic Regulations (Labeling Regulations for Cosmetics), 21 CFR 210, 21 CFR 211 and current Good Manufacturing Practices (cGMPs).
- Quality Management Module within SAP
- Experience in Quality Assurance, Quality Systems, or New Product Development in a regulated environment is required.
- Knowledge of ISO 9001 and ISO 22716
- Knowledge of USP and/or ISO microbiological test methods
- Experience in technical transfer, process development, analytical chemistry, clinical research, microbiology, product safety, product stability and process validation is preferred.
- Demonstrated verbal and written communication skills
We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.
If you require a reasonable accommodation to complete an application for a recognized disability under applicable law, please email USApplicationAccommodation@support.lorealusa.com
. Please note this email will only respond to specific requests for assistance completing the application as a request for accommodation for a disability. All others will not be considered.