Onsite QA Specialist – Manufacturing Compliance & NPI

ProQuality Network; Juncos (PR); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Amgen is seeking a QA Specialist to support its Quality Assurance program on-site. You will perform QA activities with minimal supervision, ensuring compliance with quality standards, regulatory requirements, and internal procedures.

The role involves leading investigations, audits, and change control across manufacturing and distribution processes. The ideal candidate has strong documentation skills, experience in regulated environments, and the ability to interact with regulatory agencies

Qualifications

• Must have 1 of: Master’s + 2 years related experience; Bachelors + 4 years; Associates + 8 years; High school/GED + 10 years of related experience.
• Experience in regulated manufacturing environments and CQV processes is preferred.
• Strong technical writing, documentation, and data trending skills are required.

Responsibilities

• Review and approve MPs and process validation protocols.
• Lead investigations and CAPA, drive timely resolutions.
• Represent QA on incident triage, NPI teams, and CCRB designee.
• Review environmental characterization, maintenance WO, EMS/BMS alarms, and NC investigations.

Skills

Quality Assurance

Regulatory compliance

QA Leadership

Documentation & writing

Cross-functional teamwork

Auditing

Education

Master's + 2 years of related experience

Bachelor's + 4 years of related experience

Associates + 8 years of related experience

High school + 10 years of related experience

Job description

Amgen is seeking a QA Specialist to support its Quality Assurance program on-site. You will perform QA activities with minimal supervision, ensuring compliance with quality standards, regulatory requirements, and internal procedures.

The role involves leading investigations, audits, and change control across manufacturing and distribution processes. The ideal candidate has strong documentation skills, experience in regulated environments, and the ability to interact with regulatory agencies