Senior QA Specialist – GMP, Regulatory & Batch Review

Integrated Resources, Inc ( IRI ); Cambridge (MA); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Integrated Resources, Inc (IRI) is seeking a Pharmaceutical Quality Assurance professional to review event documentation, batch records, and regulatory filings. The role encompasses product disposition for drug substances, products, devices, and finished goods, and supports design verification and DHF deliverables.

The candidate will build and maintain PSF for client programs, demonstrate strong regulatory knowledge of FDA/EMA guidelines, and collaborate to ensure timely, compliant release in a

Formación

• BS degree in life sciences, engineering or related field required.
• Minimum 5 years of pharma QA experience in GMP manufacturing/supply chain.
• Solid understanding of FDA and EMA regulations and guidelines.

Responsabilidades

• Review event documentation such as batch records, exceptions, and regulatory filings.
• Perform production record review and product disposition for drug substance, drug product, device assembly and finished goods.
• Support design development plan including design verification and DHF deliverables.
• Build and maintain Product Specification Files (PSF) for client program.

Conocimientos

Regulatory knowledge

GXP compliance

Teamwork and initiative

Independent prioritization

Communication skills

Problem solving

Organization skills

Attention to deadlines

Computer proficiency

Educación

BS in life sciences/engineering

Herramientas

Microsoft Office

Descripción del empleo

Integrated Resources, Inc (IRI) is seeking a Pharmaceutical Quality Assurance professional to review event documentation, batch records, and regulatory filings. The role encompasses product disposition for drug substances, products, devices, and finished goods, and supports design verification and DHF deliverables.

The candidate will build and maintain PSF for client programs, demonstrate strong regulatory knowledge of FDA/EMA guidelines, and collaborate to ensure timely, compliant release in a