Biologics QA Specialist - Batch Review & Compliance

Regeneron Pharmaceuticals; Rensselaer (IN); In loco; USD 92.000 - 151.000; Tempo pieno

Descrizione del lavoro

Regeneron Pharmaceuticals is seeking a Quality Assurance Specialist to support Internal Bulk Batch Review activities in Manufacturing. You will participate in deviations, change controls and CAPAs, review batch records, and collaborate across departments to resolve issues while ensuring QA policy compliance.

The role requires a BS/BA in a scientific field, with 2–6 years of QA experience depending on level.

Competenze

• BS/BA in scientific discipline or related field; substitution of experience allowed.
• Minimum experience: Assoc QA Specialist: 2+ years; Specialist: 4+ years; Sr Specialist: 6+ years.
• Understanding of biologics manufacturing operations and QA processes.
• Ability to prioritize tasks and meet deadlines in a fast-paced environment.

Mansioni

• Represent QA in deviations, change controls, CAPAs and investigations.
• Review batch records and coordinate with departments to resolve issues.
• Provide QA guidance aligned with policies and procedures.
• Train/mentor junior staff and support process education.
• Dispostion activities including document review and labeling.

Conoscenze

Deviations review & investigation

Change controls

CAPA handling

Cross-functional communication

Documentation & QA policies

Formazione

BS/BA in scientific discipline

Strumenti

Computerized systems

Batch record review tools

Descrizione del lavoro

Regeneron Pharmaceuticals is seeking a Quality Assurance Specialist to support Internal Bulk Batch Review activities in Manufacturing. You will participate in deviations, change controls and CAPAs, review batch records, and collaborate across departments to resolve issues while ensuring QA policy compliance.

The role requires a BS/BA in a scientific field, with 2–6 years of QA experience depending on level.