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Process Alliance · 1 day ago

Deviation Writer

Durham, NC

Full-time

Onsite

Entry Level

1+ years exp

Process Alliance is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering, automation, manufacturing services, and medical devices. They are hiring a deviation writer to join a pharmaceutical manufacturing team, responsible for writing deviation reports and collaborating with cross-functional teams to ensure compliance with GMP standards.

ManufacturingMedicalPharmaceuticalProduct Design

Hiring Manager

Devin Courtney

Responsibilities

Write detailed deviation reports, documenting investigations in compliance with GMP standards

Collaborate with cross-functional teams (QA, manufacturing, QC, engineering) to gather data and support root cause analysis

Ensure timely closure of deviations and support CAPA documentation as needed

Participate in deviation trending and reporting to drive continuous improvement

Qualification

GMP deviation investigationsPharmaceutical industry experienceAnalytical skillsWriting skillsQuality systems familiarityPackaging experienceQuality Control Lab experience