Overview
On Site
Full Time
Skills
Computerized System Validation
Training
Distribution
Quality Management
QMS
Document Management
Change Control
Process Improvement
Policies and Procedures
Root Cause Analysis
ROOT
Research and Development
Manufacturing Operations
Purchasing
Packaging Engineering
Legal
Corrective And Preventive Action
Quality Assurance
Quality Control
Chemistry
Microbiology
Data Analysis
Auditing
Inspection
Good Manufacturing Practice
OTC
Regulatory Compliance
Manufacturing
Critical Thinking
Management
Communication
Decision-making
Supervision
Privacy
Marketing
Job Details
Location: Lewisville, TX
Description: Our client is currently seeking a Engineering Consultant
Top 5 Qualifications
Preferred Certifications:
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:
Key Responsibilities
Quality Management System (QMS)
Inspection Readiness
Root Cause Analysis
Internal Auditor
Skills & Experience
Additional Skills & Abilities
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Description: 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.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
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