Tipo de Emprego: Tempo Integral
Localização: New Jersey - Piscataway
The purpose for this role is to ensure Quality Management Systems are adequately maintained and continuously improved. Responsible for managing the programs required for compliance to FDA regulation for OTC drug products and L’Oreal system requirements.
- Leads and responsible for CAPA, Supplier Quality Audits, Internal Audits, and customer complaints handling.
- Manages and facilitates investigation and resolution of quality incidents, process deviations and customer complaints and inquiries.
- Improves quality management systems plant-wide to achieve zero defects through hands-on training, strong work ethic, and leadership by example.
- Identifies and resolves systemic quality problems. Coaches and champions problem solving techniques.
- Successfully interfaces with key internal and external partners to improve quality.
- Establishes and performs to measures that monitor performance related to site quality KPI. Analyzes and reports on product and process quality trends and quality system integrity against standards. Establish and executes plan to continuously improve Quality standards.
- Manage the internal and external audits of the facility: Perform audits, Coordinates and records documents requested by external auditors, documents audit activities for external auditors, ensures corrective measures are taken by the appropriate department in a timely manner.
- Participate & Assist during FDA inspections, Notified Body, and other third party Quality System evaluations. (FDA, ISO9001, ISO 22716, DGO, etc…)
- Participate in project management/performance team meeting on behalf of the quality department in order to provide ideas, methods or processes for unit/company performance improvement. Lead and participate in Performance Improvement projects.
- Develops a high performing team and drives personal development.
- Develops and manages the training program regarding Quality Management System, and problem-solving.
Educational or Certification Requirements:
- BS Degree in a Science or Engineering field, Masters preferred.
- Experience in a manufacturing environment with cGMP preferred in FMCG and/or OTC.
- Minimum 5 years of experience in a Quality management role or relevant industry experience.
- Team leader and change agent
- SPC, and/or lean tools
- Current PC Skills utilizing Excel, and related MS Office Software are necessary for success.
- Must be able to act with discretion and confidentiality.
- Requires ability for test design and interpretation of results.
- Must have strong communication skills, presentation skills, writing 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.
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