Specialist QA- 35845

CIS International LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

CIS International LLC seeks a Specialist QA for on-site work in Juncos, PR. The role supports Amgen's QA program with responsibilities spanning NPI, change control, FATs, validation, PPQs, incident triage, and regulatory interactions.

The position is full-time with a potential extension based on performance and budget. Ideal candidates hold advanced degrees with substantial related experience and strong leadership in cross-functional teams, investigations, and quality systems.

Qualifications

• Doctorate or Masters with related experience required.
• Bachelor’s + 4 years related experience required.
• Associates + 8 years related experience or equivalent.
• High school/GED + 10 years related experience acceptable.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead investigations and site audits.
• Own site quality program procedures.
• Review and approve change controls and CAPA records.
• Provide lot disposition and authorize lots for shipment.

Skills

Project management

Cross-functional collaboration

Regulatory interaction

Investigation leadership

Documentation and recordkeeping

Attention to detail

Education

Doctorate or Masters + 2 years related experience

Bachelors + 4 years related experience

Associates + 8 years related experience

High school/GED + 10 years related experience

Tools

MS Word

MS Excel

Electronic Quality Systems

Job description

Specialist QA- 35845 (NPI, Change Control, FATs, Validation & PPQs.)

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

• Doctorate orMasters + 2 years of directly related experience.
• Bachelors + 4 years of directly related experience.
• Associates + 8 years of directly related experience.
• High school/GED + 10 years of directly related experience.

PREFERRED QUALIFICATIONS

• NPI, Change Control, FATs, Validation, and PPQs.

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 on site job in Juncos, PR
• Full time job
• Expected project duration: 3months for the first contractwith a high possibility of extension based on performance and budget.
• AdministrativeShift(weekends and overtime may also be required).
• Expected hiring date: November 2026