Sr. Specialist QA- 35712

Cis-International-LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen in Juncos, PR seeks a senior QA professional to support the Quality Assurance program, review and approve product MPs, and lead cross-functional investigations.

Responsibilities include on-site release of validated processes, environmental characterization, incident triage, and QA representation on NPI teams, with a 12-month contract and possible extension based on performance and budget.

Qualifications

• Experience with commissioning and qualification, equipment validation.
• Knowledge of QRAES, Kneat, Good Documentation Practices, Change Controls, SOPs.
• Demonstrated interaction with regulatory agencies.
• Strong project management and cross-functional leadership.
• Ability to lead investigations and own site quality program procedures.

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

Cross-functional leadership

Negotiation skills

QA knowledge

Regulatory interaction

Documentation & data analysis

Process development

Communication skills

Independent work

Data trending

Compliance evaluation

Amgen values

Education

Doctorate

Masters

Bachelors

Associates

High school/GED

Job description

SUMMARY:

In support of Amgen'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:

• 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.

PREFERRED QUALIFICATIONS:

• The candidate should have experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, Good Documentation Practices, Change Controls, SOP’s etc.

SKILLS:

• Project management 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.

WORK METHODOLOGY:

• Full on site job in Juncos, PR
• Full time job
• Expected project duration: 12months for the first contractwith a high possibility of extension based on performance and budget.
• Administrative Shift(weekends and overtime may also be required).
• Expected hiring date: September 2026