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Our client is currently seeking a Engineering Consultant
Top 5 Qualifications
Investigations, Root Cause Analysis, or Corrective Actions - Critical
Experience in Computer System Validation - Critical
Annual Product Review - Would be Nice
Experience with Validation, Process, Cleaning, or Equipment Validation - Would be Nice
Experience with Stability Programs - Would be Nice
Preferred Certifications :
Certified Quality Auditor
Certified Quality Engineer
Certified Quality Manager
Job Summary
The role serves as a technical / subject matter expert for compliance quality-related issues and works to resolve these issues while improving quality globally. As an internal auditor and member of the Quality Systems team, the individual will assist in the day-to-day operations of Quality Systems processes, including :
Batch Record Review
Over-the-Counter (OTC) Drug and Nutritional Product Release
Annual Product Review (APR)
Validation Support
Change Control
Training
Document Control & Distribution
Investigation & Root Cause Analysis
Inspection Readiness
Key Responsibilities
Quality Management System (QMS)
Oversee batch record review, document control, change control, annual OTC product review, validation support, and stability support.
Investigate and review quality events and market quality concerns.
Assist in process improvement initiatives to streamline compliance requirements and incorporate best practices.
Support special projects aligned with business and compliance goals.
Inspection Readiness
Stay updated on global regulatory changes that could impact Mary Kay products.
Assist in the implementation, monitoring, and maintenance of compliance policies and procedures.
Ensure compliance with global Quality standards and conduct internal audits of Mary Kay manufacturing centers and subsidiaries.
Provide audit support for FDA, TDH, Health Canada, and other external regulatory agencies.
Root Cause Analysis
Perform investigations into product quality issues, identifying root causes and implementing corrective actions.
Support failure investigations across Quality, R&D, Manufacturing Operations, Purchasing, Package Engineering, and Legal.
Ensure long-term systemic resolution and monitor the effectiveness of implemented changes.
Internal Auditor
Serve as an internal auditor, ensuring that the site operates in compliance with regulations.
Develop audit plans and execute audits, documenting findings and corrective action plans as necessary.
Assess manufacturing processes and work collaboratively with internal departments to ensure Mary Kay Quality Standards are upheld.
Skills & Experience
Experience : 3+ years in quality assurance or quality control
Education : Bachelor's / University Degree - Field of Study : Chemistry, Microbiology
Decision Making : Uses judgment based on information analysis
Additional Skills & Abilities
Strong understanding of advanced quality principles, audit protocols, inspection procedures, FDA and cGMP regulations.
Knowledge of OTC product compliance and various manufacturing processes / formulations.
Ability to apply advanced concepts and theories to develop new systems and principles.
Critical thinking & time management to analyze and solve complex problems.
Effective oral and written communication skills for interaction with personnel across various cultures.
Capable of independent decision-making with minimal supervision.