Quality Specialist I: GMP Docs & Audit Support

Aptar Italia S.P.A.; Gibsonia (Allegheny County); Presencial; USD 60 000 - 80 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401k plan with Company matching

Paid time off

Medical, dental, vision benefits

Resumo da oferta

Aptar Pharma in Gibsonia, PA is seeking a Quality Specialist I to support the Quality Management System, document control, audits, and regulatory compliance. This role assists with records management, training, and CAPAs to ensure product quality and compliance.

The position emphasizes collaboration with QA, labs, and management to maintain data integrity and effective quality processes in a GMP environment.

Qualificações

• Four-year degree or equivalent in Life Sciences.
• 1–2 years in quality, manufacturing, or a regulated industry.
• Experience with FDA/EMA/ISO standards is preferred.
• Strong documentation and data integrity skills.

Responsabilidades

• Coordinate and assist with scheduling internal and external audits.
• Prepare and organize required documentation in advance of inspections.
• Provide on-site support during audits, including document retrieval and coordination with QA and laboratory personnel.
• Convert paper-based records to electronic formats per ALCOA principles.
• Maintain electronic and physical records; manage off-site archival storage.
• Assist in administering the electronic document management system and review changes.

Conhecimentos

Audit support

Record control

Document control

Quality systems

Data management

Project quality review

Logbook control

Equipment management

Asset management

Formação académica

Four-year degree or equivalent in Life Sciences

Descrição da oferta de emprego

Aptar Pharma in Gibsonia, PA is seeking a Quality Specialist I to support the Quality Management System, document control, audits, and regulatory compliance. This role assists with records management, training, and CAPAs to ensure product quality and compliance.

The position emphasizes collaboration with QA, labs, and management to maintain data integrity and effective quality processes in a GMP environment.