Quality Control - Technical Writer

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

Job Responsibilities

This role will provide non-testing support to the QC Product Technical Support department. This scope includes coordination of generating validation documents to support product validation at the Client Andover site. The technical skills within scope will require understanding of the scientific principles of test methods, data analysis and cGMP requirement. The candidate will be responsible for facilitating lifecycle management through collaboration with laboratory subject matter experts (SMEs) and analysts.

• Authoring method validation documents using document workflow, through collaboration with SMEs
• Use of the Laboratory Management System (LIMS)
• Supporting assay improvement activities and generating supporting documents
• Participating in across site meetings and tracking the project timeline

Successful candidate requirements

• Knowledge of QC microbial support and technical writing
• Strong interpersonal and written communication skills
• A detail-oriented approach to deliverables as the main job responsibility is data review and generation of GMP documentation
• A degree in science, preferably in microbiology or related technical discipline
• Past experience supporting GMP writing in the biopharmaceutical field

Skills

Knowledge of QC microbial support technical writing

Strong interpersonal communication skills microbiology

Education/Experience

N/A