Sr. Specialist QA

CIS International LLC; Juncos (PR); On-site; USD 90,000 - 170,000; Full time

Job summary

CIS International LLC seeks a senior QA professional to manage and improve quality systems across manufacturing and distribution processes in the United States and Puerto Rico. The role requires leading cross-functional teams and representing QA on critical incident triage.

Responsibilities include approving validation protocols, releasing sanitary utility systems, and mentoring the QA team. Extensive regulatory interaction experience and strong communication are essential.

Qualifications

• Doctorate with 2+ years related experience.
• Master's with 4+ years related experience.
• Bachelor's with 6+ years related experience.
• Associate's with 10+ years related experience.
• High school/GED with 12+ years related experience.

Responsibilities

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

Skills

Cross-functional leadership

Regulatory interactions

QA/QA validation

Manufacturing/Distribution knowledge

Data trending

Audit readiness

Communication skills

Independent worker

Education

Doctorate

Masters

Bachelors

Associates

High school/GED

Job description

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

EDUCATION:

• Doctorate + 2 years of directly related experience.
• Masters + 4 years of directly related experience.
• Bachelors + 6 years of directly related experience.
• Associates + 10 years of directly related experience.
• High school/GED + 12 years of directly related experience.

SKILLS:

• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teams
• Enhanced 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 Amgen Values/Leadership Practices.