Quality Control - Technical Writer

SGS Consulting; Milton (MA); On-site; USD 70,000 - 110,000; Full time

Job summary

SGS Consulting is seeking a QC support professional to assist the Product Technical Support team in validation document generation for client site product validation. Strong microbiology knowledge and GMP writing experience are required.

The role emphasizes collaboration with SMEs, data review, and generating GMP documentation while coordinating timelines across sites. A science degree in microbiology or related field is preferred.

Qualifications

• Experience writing GMP documentation in biopharmaceutical settings is preferred.
• Familiarity with validation concepts and data review processes.
• Strong documentation, organization, and attention to detail.

Responsibilities

• Author method validation documents using document workflow with SMEs.
• Coordinate validation document generation to support product validation at client site.
• Facilitate lifecycle management through collaboration with SMEs and analysts.
• Participate in across-site meetings and track project timelines.

Skills

QC microbial support

Technical writing

Interpersonal skills

Written communication

Microbiology

Education

Science degree in microbiology or related field

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. The key responsibilities of the candidate are as follows:
• 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 requires: 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