Sr Specialist QA

Weil Group, Inc; Juncos (PR); On-site; USD 95,000 - 125,000; Full time

Job summary

Weil Group, Inc. is seeking a Senior QA professional to act as a technical specialist in support of the Quality Assurance program. The role requires reviewing and approving product MPs, leading investigations, and owning site quality procedures to ensure compliance.

The position involves representing QA on cross-functional teams, coordinating regulatory interactions, and maintaining robust quality systems across manufacturing and distribution processes at the Juncos, PR site.

Qualifications

• Minimum education as listed: Doctorate with related experience or Master’s with related experience or Bachelor’s with extensive experience or Associate’s with longer experience or high school diploma with extended experience.

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

Leadership and negotiation

Regulatory interaction

Documentation and data analysis

Communication and presentation

Independent working

Data trending and evaluation

Education

Bachelor's degree or higher in a related field

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.