QA Specialist I: Build Quality & Compliance (GMP)

SOFIE Inc.; Houston (TX); Sur place; USD 45 000 - 50 000; Plein temps

Résumé du poste

SOFIE Inc. is seeking a Quality Assurance Specialist I to oversee the QA program and QMS at a SOFIE manufacturing site. The role ensures product quality and regulatory compliance across all operations.

You will collaborate with the Facility Manager and Operations team, write and approve SOPs, and participate in audits to maintain CGMP standards. A related degree and QA experience are required.

Qualifications

• Bachelor’s degree in science, quality, or related field.
• 1–2 years QA, Pharmacy, CGMP manufacturing experience preferred.
• Knowledge of USP, FDA, and cGMP regulations preferred.
• Ability to write, review, and revise SOPs.

Responsabilités

• Oversee QA program and QMS at a SOFIE manufacturing site.
• Apply QA processes to ensure product quality and regulatory compliance.
• Write, review, approve, and implement procedures and specs.
• Conduct audits and coordinate with inspectors and operations.

Connaissances

Strong interpersonal communication

Problem solving

MS Office proficiency

Communication with inspectors

Formation

Bachelor’s Degree

Associate’s Degree

Outils

MS Office

Description du poste

SOFIE Inc. is seeking a Quality Assurance Specialist I to oversee the QA program and QMS at a SOFIE manufacturing site. The role ensures product quality and regulatory compliance across all operations.

You will collaborate with the Facility Manager and Operations team, write and approve SOPs, and participate in audits to maintain CGMP standards. A related degree and QA experience are required.