QA Specialist — cGMP Quality Assurance (Night Shift)

Amgen; Puerto Rico; Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Amgen seeks a Specialist QA to serve as a key quality partner to manufacturing operations, ensuring cGMP compliance and adherence to regulatory expectations. The role supports non-standard 12‑hour night shifts with potential schedule adjustments as needed.

Responsibilities include disposition of bulk drug substances, QA oversight of manufacturing, testing, storage, and distribution, and continuous improvement projects to enhance efficiency and compliance.

Qualifikationen

• Doctorate or equivalent in life sciences or engineering.
• Master's degree with 2+ years QA/manufacturing support experience or Bachelor's with 4+ years QA/manufacturing support experience.
• Associate's with 8+ years QA/manufacturing support, or High school/GED with 10+ years QA/manufacturing support.

Aufgaben

• Execute Quality disposition (approval or rejection) of bulk drug substances.
• Provide Quality oversight for clinical and commercial drug substance operations to ensure compliance with cGMP, cGLP, and other regulatory requirements.
• Ensure deviations, quality events, and changes are identified, assessed, documented, and managed.
• Ensure production records, testing results, facilities, equipment, materials, processes, and procedures meet cGMP and inspection readiness.
• Collaborate to ensure QMS processes are effectively executed and compliant operations.
• Champion continuous improvement initiatives to enhance quality and compliance.
• Complete required training and maintain training compliance.
• Support internal and external audits and regulatory inspections as a Quality Unit representative.

Kenntnisse

Quality Assurance

Regulatory knowledge

Communication skills

Bilingual English/Spanish

Cross-functional collaboration

Documentation & records

Ausbildung

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

CDOCS

Maximo

TrackWise

LIMS

MES/electronic batch record systems

SAP

Jobbeschreibung

Amgen seeks a Specialist QA to serve as a key quality partner to manufacturing operations, ensuring cGMP compliance and adherence to regulatory expectations. The role supports non-standard 12‑hour night shifts with potential schedule adjustments as needed.

Responsibilities include disposition of bulk drug substances, QA oversight of manufacturing, testing, storage, and distribution, and continuous improvement projects to enhance efficiency and compliance.