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

CIS International LLC; Juncos (PR); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

Amgen is seeking a Specialist QA to support NPI, Change Control, FATs, Validation, and PPQs in a full-time, on-site role in Puerto Rico. The candidate will review and approve MP releases, validation documents, and environmental reports, while coordinating with cross-functional teams and regulatory agencies as needed.

The role emphasizes leading investigations, QA on NPI, and ownership of site quality procedures, with potential for contract extension based on performance and budget.

Qualifications

• Must have advanced degree with related experience as listed.
• Requires strong project management and cross-functional collaboration.
• Experience interacting with regulatory agencies is a plus.
• Ability to lead investigations, audits and CAPA records.

Responsabilités

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

Connaissances

Project management

Organizational skills

Cross-functional leadership

Negotiation

Communication

Independent work

Formation

Doctorate or Masters + 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

Description du poste

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

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:

• Doctorate or Masters + 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