QA Analyst II — GMP, Audits & SOPs

Vyriad; Rochester (MN); Sur place; USD 70 000 - 95 000; Plein temps

Résumé du poste

Vyriad is seeking an experienced QA Analyst II to strengthen our Quality Assurance team in a manufacturing setting. The role requires independent work, including drafting SOPs, conducting audits, and guiding processes with GMP principles.

You will train teams on quality practices, review records, and collaborate cross-functionally to drive data-driven improvements, CAPA programs, and robust documentation. Bachelor’s degree in science and at least two years in manufacturing QA are required, with

Qualifications

• Bachelor’s degree in a science-related field and at least 2 years in manufacturing QA.
• Knowledge of FDA GMPs; GLP/ISO desired.
• Excellent written and verbal communication.
• Detail-oriented with ability to work independently and take initiative.

Responsabilités

• Provide QA guidance to a variety of business units.
• Independently draft forms and SOPs.
• Conduct data gathering and desk reviews.
• Review documents for clarity and compliance.
• Lead investigations, CAPA, and process improvements.
• Train teams on GMPs and quality principles.
• Support cross-functional teams and audits.
• Manage third-party providers' compliance.
• Respond to customer and regulatory complaints.
• Participate in continuous improvement activities.

Connaissances

QA principles

GMP knowledge

Auditing skills

SOP drafting

Data analysis

Communication

CAPA investigations

Regulatory compliance

Formation

Bachelor's degree in science

2+ years QA manufacturing experience

Description du poste

Vyriad is seeking an experienced QA Analyst II to strengthen our Quality Assurance team in a manufacturing setting. The role requires independent work, including drafting SOPs, conducting audits, and guiding processes with GMP principles.

You will train teams on quality practices, review records, and collaborate cross-functionally to drive data-driven improvements, CAPA programs, and robust documentation. Bachelor’s degree in science and at least two years in manufacturing QA are required, with