Specialist QA- 35670

Cis-International-LLC; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Amgen seeks a QA professional to support its Quality Assurance program on-site in Juncos, PR. The role involves reviewing and approving MPs, validation reports, and environmental characterization, while leading investigations and site audits.

Responsibilities include ownership of site quality procedures, managing change controls, and ensuring compliance with regulatory requirements. 5-month initial contract with potential extension based on performance and budget.

Qualifications

• Masters degree with 2+ years of directly related QA experience.
• Bachelor's degree with 4+ years of directly related QA experience.
• Experience with GMP, QA, QAL and validation activities.

Responsibilities

• Review and approve product MPs and process validation docs.
• Approve environmental characterization and sanitary utility reports.
• Lead investigations and site audits.
• Own site quality program procedures and change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

Project management

Organizational skills

Cross-functional leadership

Negotiation

Regulatory interactions

Data analysis

Communication

Independent work

Education

Master's degree

Bachelor's degree

Tools

MS Office Suite

Job description

SUMMARY:
Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision.
FUNCTIONS:

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

EDUCATION:

• Masters + 2 years of directly related experience.
• Bachelors + 4 years of directly related experience.

PREFERRED QUALIFICATIONS:

• Change Control, Documentation Review, Validation, PPQ.

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 process development.
• Demonstrate 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- time job
• Full on-site job
• Location: Juncos, PR
• Expected hiring month: September 2026
• Initial contract term: 5 monthsfor the first contractwith a high possibility of extension based on performance and budget.
• Number of openings: 1
• Administrative Shift(weekends and overtime may also be required).
• Professional services contract