GMP Quality Ops Analyst II - Floor Support

BioLife Plasma

Massachusetts

Vor Ort

USD 72.000 - 113.000

Vollzeit

Vor 8 Tagen

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Zusammenfassung

Takeda in Massachusetts seeks a Quality Operations Analyst II, Floor Support to provide real-time quality oversight of GMP manufacturing operations. You will work with Manufacturing, Facilities, Engineering, Quality Control, Regulatory Affairs, and Quality Systems to maintain inspection readiness and ensure product quality.

Ideal candidates have 4+ years in life sciences with GMP/GDP knowledge and experience with TrackWise, SAP, LIMS, and Veeva, plus strong communication and problem-solving

Qualifikationen

Bachelor’s degree or higher in life sciences, engineering, chemistry, microbiology, biotechnology, or related field.
4+ years of relevant industry experience in life sciences or a GMP-regulated environment.
Knowledge of GMP, GDP, data integrity, quality systems, and risk management.

Aufgaben

Provide routine quality oversight and real-time support of GMP manufacturing operations.
Review, issue, and approve documents such as batch records, logbooks, protocols, and reports.
Support deviations, CAPAs, change controls, internal and regulatory audits, and inspections as needed.
Monitor quality metrics and drive continuous improvement.

Kenntnisse

GMP knowledge

GDP knowledge

Quality systems

TrackWise

SAP

LIMS

Veeva

Lean Six Sigma

Attention to detail

Communication

Ausbildung

Bachelor’s degree in life sciences

Tools