Sr. Quality Systems Specialist

Juncos - Puerto Rico

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Provide oversight for the development implementation and maintenance of quality programs systems processes and procedures to ensure compliance with internal policies regulatory requirements and industry standards.

Ensure the performance and quality of services conform to establishedQuality System standards agency guidelines and company expectations.

Offer expertise and guidance in interpreting regulatory governmental and internal quality policies to maintain compliance across operations.

Partner with operating entities to analyze processes ensure requirement alignment and drive continuous improvement initiatives.

Lead audit and inspection preparation activities; support and coordinate during audits; drive resolution of audit and inspection findings.

Act as liaison with internal/external auditing groups and regulatory inspectors throughout the entire audit lifecycle.

Coordinate legal and quality documentation requests in support of government investigations or litigations.

Maintain and regularly update quality assurance programs procedures and documentation to align with evolving standards and regulatory expectations.

Promote uniform global quality standards and facilitate best-practice sharing across sites and teams.

Other duties may be assigned.

Requirements

Minimum of 4 years of relevant experience in the regulated industry.

Top 3 Required Experience Areas:

Strong investigation skills with demonstrated root cause analysis capabilities.
Proficient technical writing strong organization and effective communication skills.
Experience in Process Validation and Computer Software Validation (CSV).

Bachelors Degree completed with a minimum of 4 years of relevant experience.
Masters degree with a minimum of 2 years of relevant experience.
*Willing to work 100% on-Site in JuncosPR.*