Position Details


Quality Assurance Specialist / Quality Engineer
Full Time Direct Hire
Salary is DOE (target is ~90-100k)
Carlstadt, NJ (near Newark)
Available for long term employment with no Visa Sponsorship at any point

Required Skills / Experience:
• 5+ years of experience with progressive responsibilities in Quality Assurance
• Experience with Drug Quality Assurance
• 21 CFR / FDA Regulations
• CAPA (Corrective and Preventative Actions), RCA (Root Cause Analysis), Complaints, etc.
• Full Cycle Project Management

• Labeling on the Drug Side
• Statistical and Data Analysis
• Team Lead Experience
• Medical Device experience
• Master Control
• ISO Standards
• Six Sigma/Black Belt/Lean Certifications
• PMP Certificate
• Bachelor’s Degree

Soft Skills:
• Focused on how to help the company succeed while maintaining safety and adhering to regulations
• Player Coach
• Outstanding oral and written skills including technical writing
• Self-starter
• Works well with a team
• Able to multi-task
• Enjoy working in a highly detailed environment

• Reviews and assesses the appropriateness of non-conformance, planned deviation, and corrective action records in accordance with internal procedures.
• Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals).
• Plan and lead root cause analysis meetings and develop corrective action plans with content subject matter experts (SME). Implement corrective action plans with support of SME and monitor and verify CAPA effectiveness.
• Facilitates cross-functional special project teams and acts as representation for QA.
• Participates in inspections/audits by various regulatory authorities.
• Serves as QA interface to other departments and/or partners.
• Lead cross-functional special project teams and acts as representation for QA.
• Assists in development and maintenance of department Standard Operating Procedures, as needed.
• Contributes to a culture of continuous improvement through process improvement activities.
• Supports investigations through guidance of quality workflows, trend queries, and other tools.
• Contributes to the development, maintenance & reporting of department metrics, as needed.

• Medical, Dental & Vision
• Life insurance, AD&D, and Disability
• 401k

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