QA Specialist I: CGMP Manufacturing & Compliance

SOFIE; New Jersey; Presencial; USD 60.000 - 75.000; Jornada completa

Descripción de la vacante

SOFIE is seeking a Quality Assurance Specialist I to oversee the QA program and the Quality Management System at the site level, ensuring regulatory compliance for products manufactured under 21 CFR Part 212 and 211 as applicable. You will maintain oversight of quality processes and ensure materials, components, packaging, and finished dosage forms meet specifications.

Collaborating with the Facility Manager and Operations, you will write, review, and implement procedures, conduct site audits,

Formación

• Bachelor’s degree in science/quality; required or preferred.
• Experience in manufacturing operations and CGMP environment preferred.

Responsabilidades

• Maintain oversight of QA program and QMS at the site level.
• Ensure materials, components, packaging, and finished dosage forms meet specifications.
• Write, review, approve, and implement procedures and methods as required.
• Coordinate site audits and liaise with inspectors on QA topics.
• Maintain training records and oversee metrology and calibration programs.
• Support CAPA, deviation investigations and continuous improvement.

Conocimientos

Strong interpersonal communication

MS Office proficient

Problem solving

Educación

Bachelor’s Degree (Scientific / Medical / Quality)

Associate’s Degree acceptable alternative

Herramientas

MS Office

Descripción del empleo

SOFIE is seeking a Quality Assurance Specialist I to oversee the QA program and the Quality Management System at the site level, ensuring regulatory compliance for products manufactured under 21 CFR Part 212 and 211 as applicable. You will maintain oversight of quality processes and ensure materials, components, packaging, and finished dosage forms meet specifications.

Collaborating with the Facility Manager and Operations, you will write, review, and implement procedures, conduct site audits,