Analyst 2 - Quality Assurance

Medial Group; Gurabo (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

Medial Group in Gurabo, Puerto Rico, seeks a Quality Assurance professional to establish and maintain QA programs, procedures and controls. The role entails monitoring complaint databases, ensuring compliance with safety and environmental regulations, and identifying trends for management review.

The ideal candidate has at least 2 years in pharma quality investigations, a Science degree, and is willing to work 100% on-site in Gurabo.

Qualifications

• Minimum 2 years of experience with Investigations and complaints.
• Work experience with quality system in the pharma industry is acceptable.
• Bachelor's degree in Science completed.
• Willing to work 100% on-site Gurabo.

Responsibilities

• Establishes and maintains quality assurance programs, procedures and controls.
• Monitors sources of quality detractors using service and complaint databases.
• Ensures compliance with policies, procedures, quality standards; safety and environmental regulations.
• Generates and identifies significant trends; reports them to management and cross-functional teams.
• Provides advanced technical assistance in the use of information mapping technology.
• Supports product review and release functions and good manufacturing practice auditing.

Skills

Quality Assurance

Investigations

Complaints handling

Education

Bachelor's degree in Science

Tools

Information mapping software

Job description

• Industry Pharma/Biotech/Clinical Research
• City Gurabo

Job Description

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

Monitors and tracks allsources of quality detractors utilizing the service database andcomplaint database. Ensures compliance with company policies,procedures, and quality standards; as well as safety and environmentalregulations. Develops solutions to database problems of moderate scopeand complexity. Writes and assists others in writing standard operatingprocedures. Generates and identifies significant trends. Regularlyreports them to management and appropriate cross functional teams.Provides advanced technical assistance in the use of information mappingtechnology. Provides support to product review and release functions.Generates moderately complex statistical summaries. Provides support togood manufacturing practice auditing.

Requirements

Minimum 2 years of experience with Investigations and complaints. Work experience with quality system in the pharma industry isacceptable. Bachelor's degree in Science completed. Willing to work 100% on-site Gurabo.