GMP QA Specialist: CAPA, Audits & Quality Systems

Datwyler; Town of Middletown (NY); On-site; USD 80,000 - 115,000; Full time

Job summary

Datwyler is seeking a Quality Assurance professional to uphold GMP-compliant manufacturing standards at a state-of-the-art pharma packaging site. The role focuses on supporting the site quality system and aligning with global quality policies while partnering with operations to balance quality, compliance, and cost.

Responsibilities include maintaining the QMS, managing customer complaints and CAPAs, and supporting audits.

Qualifications

• Bachelor's degree preferred; science or engineering background a plus.
• 3–5 years of QA experience in a regulated environment.
• Thorough knowledge of cGMP regulations and current industry practice.
• Knowledge of ISO 9001 and ISO 15378.

Responsibilities

• Maintain Quality Management System per global standards and local needs.
• Handle customer complaints, internal quality notifications, CAPA and investigations.
• Support internal and external audits and follow up on outcomes.

Skills

Quality Assurance

English fluent

cGMP knowledge

Written communication

Education

Bachelor's degree in science or engineering

Job description

Datwyler is seeking a Quality Assurance professional to uphold GMP-compliant manufacturing standards at a state-of-the-art pharma packaging site. The role focuses on supporting the site quality system and aligning with global quality policies while partnering with operations to balance quality, compliance, and cost.

Responsibilities include maintaining the QMS, managing customer complaints and CAPAs, and supporting audits.