QC Technical Writer — GMP & Validation Docs

SGS Consulting; Boston (MA); On-site; USD 60,000 - 90,000; Full time

Job summary

SGS Consulting in Boston, MA seeks a QC Validation Support specialist to coordinate validation documentation for product validation at the Client Andover site. The role requires understanding scientific principles of test methods, data analysis, and cGMP requirements.

You will collaborate with laboratory SMEs and analysts to facilitate lifecycle management, author method validation documents, and support assay improvement activities across sites.

Qualifications

• Authoring validation documents and data review
• Familiarity with GMP documentation practices
• Collaboration with SMEs for lifecycle management

Responsibilities

• Author validation documents using document workflow with SMEs
• Use of Laboratory Management System (LIMS)
• Support assay improvement activities and generate supporting documents
• Participate in cross-site meetings and track project timelines

Skills

QC microbial support

Technical writing

Interpersonal communication

Microbiology knowledge

Education

Science degree (microbiology or related)

GMP writing experience in biopharma

Tools

LIMS

Job description

SGS Consulting in Boston, MA seeks a QC Validation Support specialist to coordinate validation documentation for product validation at the Client Andover site. The role requires understanding scientific principles of test methods, data analysis, and cGMP requirements.

You will collaborate with laboratory SMEs and analysts to facilitate lifecycle management, author method validation documents, and support assay improvement activities across sites.