QA Specialist — 12-Hour Night Shift (cGMP)

Regulatory Jobs; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan

Health insurance

Stock options

Flexible work model

Job summary

Amgen seeks a Specialist QA – AML 6 to act as a key Quality partner for manufacturing operations. You will ensure cGMP compliance, oversee drug substance operations, and manage deviations and quality events.

The role may involve a non-standard 12-hour night shift with potential schedule adjustments. The ideal candidate will have a Doctorate or equivalent, with extensive QA/manufacturing experience, deep knowledge of QA systems, and bilingual English/Spanish communication skills.

Qualifications

• PhD or equivalent required/4+ years QA or manufacturing support experience for alternate degrees

Responsibilities

• Serve as Quality partner to manufacturing operations to ensure cGMP compliance
• Provide oversight for clinical and commercial drug substance operations
• Manage deviations, quality events, and changes per procedures
• Ensure production records, testing results, and facilities comply with cGMP
• Collaborate to execute QMS processes and compliance
• Drive continuous improvement initiatives for quality and efficiency
• Complete required training and maintain compliance
• Support internal and external audits and regulatory inspections
• Escalate risks to senior management
• Provide QA support for New Product Introductions (NPI)

Skills

Bilingual English/Spanish

Leadership

Strong communication

Organizational skills

Education

Doctorate degree

Master’s degree + 2 years QA experience

Bachelor’s degree + 4 years QA

Associate’s degree + 8 years QA

High school diploma + 10 years QA

Tools

CDOCS

Maximo

TrackWise

LIMS

MES (electronic batch records)

SAP

Job description

Amgen seeks a Specialist QA – AML 6 to act as a key Quality partner for manufacturing operations. You will ensure cGMP compliance, oversee drug substance operations, and manage deviations and quality events.

The role may involve a non-standard 12-hour night shift with potential schedule adjustments. The ideal candidate will have a Doctorate or equivalent, with extensive QA/manufacturing experience, deep knowledge of QA systems, and bilingual English/Spanish communication skills.