Description:

Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives.

Duties & Responsibilities:

• Monitors and tracks all sources of quality detractors utilizing the service database and complaint database.
• Ensures compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations.
• Develops solutions to database problems of moderate scope and complexity.
• Writes and assists others in writing standard operating procedures.
• Generates and identifies significant trends.
• Regularly reports them to management and appropriate cross functional teams.
• Provides advanced technical assistance in the use of information mapping technology.
• Provides support to product review and release functions.
• Generates moderately complex statistical summaries.
• Provides support to good manufacturing practice auditing.

Preferred Qualifications:

• Experience with Investigations and complaints. If no previous experience, work experience with quality system in pharma industry is acceptable.
• Generally Requires 2-4 Years work experience.
• Education Required: University/Bachelors Degree or Equivalent

Work Methodology:

• Hybrid:  (Janssen- Gurabo, PR site) & remote.
• 8 months  (1st contract)
• All shifts that worker will work, for example, shift 1, shift 2, day shift, night shift will vary based on the need of the project. Weekends and overtime may also be required.
• W2 Not Exempt