Quality Assurance Documentation Specialist 2

Job overview

The Quality Assurance Documentation Specialist 2 role is onsite in Portsmouth, NH. Compensation is not specified. The position supports site operations across Manufacturing, Validation, MES, and Quality Control. The role reviews and approves GMP documentation and validation records so site documents are accurate, justified, and aligned with applicable procedures and data integrity requirements. It also works with internal customers and QA colleagues to resolve documentation issues and support operational projects.

What you'll do

• Independently review and approve initial and revised documents in the Document Management System, including SOPs, work instructions, eBR and automation documentation, forms, checklists, and scanned documents
• review validation and qualification protocols and summary reports
• review specified non-DMS documents
• record review observations
• follow documentation procedures and verify justified changes
• escalate issues for guidance while working with internal customers
• participate in meetings, data queries, and report compilation
• apply data integrity principles
• perform other assigned duties.

What we're looking for

Skills & competencies

quality assurance documentation specialist

gmp documentation

document review

validation

quality assurance

data integrity

manufacturing

quality control

portsmouth nh

katalyst healthcares & life sciences

Work arrangement

• Weekend coverage required

Why this role

Documentation review includes equipment and instrumentation, validation maintenance, and computer and analytical systems.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.