Sr Specialist QA

Weil Group, Inc; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Weil Group, Inc. in Puerto Rico seeks a senior QA specialist to lead quality assurance activities within the manufacturing and distribution environment.

You will review and approve process validation protocols, participate in incident triage, and release sanitary utility systems, ensuring compliance with regulatory standards. The role requires extensive QA, validation, and regulatory experience, with responsibilities spanning NPI collaboration, investigations, and ownership of site quality

Qualifications

• Experience leading cross-functional QA teams and investigations.
• Strong knowledge of manufacturing, QA, validation and release processes.
• Ability to interact with regulatory agencies and external stakeholders.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent QA on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

Skills

Project management

Organizational skills

Cross-functional leadership

Regulatory interaction

QA processes

Data analysis

Documentation

Communication

Independent work

Validation

Education

Doctorate + 2+ yrs related experience

Master's + 6+ yrs related experience

Bachelor's + 8+ yrs related experience

Associate's + 10+ yrs related experience

High school diploma/GED + 12 yrs related experience

Job description

SUMMARY

In support of Client's Quality Assurance program acts as the technical specialist. Review and approve product MPs.

FUNCTIONS

• Approve process validation protocols and reports for mfg. processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

EDUCATION/LICENSES

• Doctorate degree and 2 years of directly related experience or Master's degree and 6 years of directly related experience or Bachelor's degree and 8 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.

COMPETENCIES/SKILLS

• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teamsEnhanced skills in leading, influencing, and negotiating.
• Strong knowledge in area of expertise.
• Collaborate and coordinate with higher level outside resources.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.
• Demonstrated ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.
• Demonstrate the Client Values/Leadership Practices.

Weil Group is proud to be an Equal Employment Opportunity Employer.